Preventing and curing evidence review — 16 September 2026

Coverage: 79 existing public items reviewed, with 35 item files corrected or updated. An additional 12 distinct research or historical programme items were added during the second discovery pass below. Review cutoff: 16 September 2026; comparison baseline: 27 August 2026.

What this ledger certifies

This is an item-level substantive review of the displayed scientific claims, trial status, eligibility, evidence interpretation and access descriptions against the cited primary publications (full text where accessible, otherwise abstract/metadata), current registry records, regulator labels, and programme/sponsor pages. Each entry records the main claim check and its limits. It is not a claim that every sentence of every historical full paper or every local reimbursement pathway was independently verified. HTTP success, publication metadata and source retrieval alone were not counted as claim verification. Unchanged historical review dates were not bulk advanced. Dates advanced on corrected items reflect the substantive checks described here; item scores remain editorial judgments, not measured treatment effects.

Current ClinicalTrials.gov evidence comes from the v2 records retrieved for this refresh. Estimated dates remain estimates; a passed date is not a result. Trial-only eligibility is not a product label. Company releases and conference abstracts remain identified as such. An unsuccessful registration search is not proof that no trial exists anywhere.

Important source discrepancies and limits

• The new general-population consensus is DOI 10.1007/s00125-026-06841-z, published 10 September. Its primary text recommends screening at 2–4, then 6–8 and 10–15 if negative. The convening organization’s announcement says 4–6 for the middle window. The item follows the paper. This consensus is not a new outcomes trial or a funding mandate.
• Current June US teplizumab label: Sanofi-hosted prescribing information. The formerly cited FDA s013 April label does not support the June stage-3 indication. Boxed viral-reactivation warning and contraindications were materially missing from the old summaries.
• Kriya’s current primary page names KRIYA.288 with glucokinase payload. Identity with older media-described KRIYA-839 insulin-plus-glucokinase has not been established. No public T1D registration was located in the sponsor search; do not invent a trial.
• Dynamic conference/CTIS pages, several blocked publisher pages, T1DRA direct-homepage retrieval and T1Detect current ordering remain access limitations. Where abstract-only or manufacturer evidence was available, that is identified below; it does not warrant a blanket “all public claims independently verified” certification.
• EASD presentations scheduled after 16 September, NIH 22–23 September workshop, planned Q4 INDs and later trial completion dates are future events. Previously public conference abstracts remain abstract-level evidence, not completed conference presentations or peer-reviewed outcomes.

Item-by-item ledger

01. abatacept-prevention — Abatacept (CTLA4-Ig)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Historical randomized outcomes checked: ~9.6-month lag in C-peptide decline; stage-1 prevention HR 0.702, P=.11 did not establish prevention. C-peptide preservation is not prevention approval.
• Registry NCT00505375: COMPLETED; updated 2020-05-06; enrollment 112 (ACTUAL); primary completion 2012-05 (ACTUAL); results posted.
• Registry NCT01773707: COMPLETED; updated 2024-06-06; enrollment 212 (ACTUAL); primary completion 2021-12-14 (ACTUAL); results posted.
• Primary publication/regulatory sources checked or consulted: dbi20-0054; dci24-0042; S0140-6736%2811%2960886-6; dc13-0604; dc22-2200.

02. alefacept-immunotherapy — Alefacept (CD2 memory T-cell targeting)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: T1DAL primary 12-month endpoint missed; secondary and 24-month C-peptide/hypoglycemia outcomes favorable. No current marketed T1D treatment established.
• Registry NCT00965458: TERMINATED; updated 2017-07-06; enrollment 49 (ACTUAL); primary completion 2013-03 (ACTUAL); results posted.
• Primary publication/regulatory sources checked or consulted: S2213-8587%2813%2970111-6; JCI81722.

03. avant1a-covid-vaccine-prevention — AVAnT1A (early COVID-19 vaccination, GPPAD primary prevention)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: AVAnT1A is primary prevention in genetically at-risk infants, not demonstrated efficacy. Vaccine licensure for infection is not a T1D indication; no outcome upgrade.
• Registry NCT06452654: RECRUITING; updated 2025-09-23; enrollment 2252 (ESTIMATED); primary completion 2027-10 (ESTIMATED); results not posted in retrieved record.

04. baricitinib-prevention — Baricitinib (JAK1/2 inhibitor)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: BANDIT 48-week C-peptide effect and safety abstract checked; current BARICADE registries recruit ages 1–35. Removed unsupported inexpensive/generic-style availability and inference that continuous treatment is established as necessary.
• Registry NCT07222137: RECRUITING; updated 2026-09-04; enrollment 150 (ESTIMATED); primary completion 2031-07 (ESTIMATED); results not posted in retrieved record.
• Registry NCT07222332: RECRUITING; updated 2026-09-04; enrollment 300 (ESTIMATED); primary completion 2028-07 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: NEJMoa2306691; s13063-022-06356-z; s12916-025-04201-z; 207924s006lbl.pdf; dbi20-0054.

05. frexalimab-cd40l — Frexalimab (CD40L antagonist)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: FABULINUS protocol publication is a design paper, not efficacy. Pediatric cohort and current registry context checked; no T1D outcome upgrade.
• Registry NCT06111586: ACTIVE_NOT_RECRUITING; updated 2026-06-29; enrollment 197 (ACTUAL); primary completion 2027-04-28 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: dom.70785.

06. gad-alum-immunotherapy — GAD-alum antigen-specific immunotherapy (Diamyd)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: DIAGNODE-3 failure/discontinuation retained against sponsor primary updates; historical genotype-subgroup benefit did not establish replicated efficacy. No new programme revival located.
• Registry NCT03345004: COMPLETED; updated 2023-01-09; enrollment 109 (ACTUAL); primary completion 2020-07-13 (ACTUAL); results posted.
• Registry NCT05018585: TERMINATED; updated 2026-08-26; enrollment 321 (ACTUAL); primary completion 2026-06-24 (ACTUAL); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: jama.2013.6285; NEJMoa0804328; dc21-0318; s00125-020-05227-z; dgac343.
• Programme/sponsor/conference source boundary: Diamyd Medical reports negative interim results of Phase 3 DIAGNODE-3 trial (manufacturer); Diamyd Medical discontinues DIAGNODE-3 following evaluation confirming futility; initiates strategic review (manufacturer); Diamyd Medical provides an update on strategic review and financial position (manufacturer).

07. golimumab-anti-tnf — Golimumab (anti-TNF)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: T1GER 52-week and 104-week follow-up checked. Stage-1 platform registration is a planned prevention test and cannot support onset-delay efficacy.
• Registry NCT07683026: NOT_YET_RECRUITING; updated 2026-07-06; enrollment 255 (ESTIMATED); primary completion 2032-09-01 (ESTIMATED); results not posted in retrieved record.
• Registry NCT02846545: COMPLETED; updated 2025-02-04; enrollment 84 (ACTUAL); primary completion 2019-05-21 (ACTUAL); results posted.
• Registry NCT03298542: COMPLETED; updated 2025-02-03; enrollment 8 (ACTUAL); primary completion 2020-12-21 (ACTUAL); results not posted in retrieved record.
• Registry NCT04729296: WITHDRAWN; updated 2021-12-02; enrollment 0 (ACTUAL); primary completion 2027-07-01 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: NEJMoa2006136; dc22-0908; 125289s146lbl.pdf.

08. hydroxychloroquine-prevention — Hydroxychloroquine for stage-1 T1D prevention

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: TN22 HR 0.95/futility and no reported retinal safety concern supported by trial publication; no prevention benefit.
• Registry NCT03428945: TERMINATED; updated 2024-04-09; enrollment 273 (ACTUAL); primary completion 2022-10-27 (ACTUAL); results posted.
• Primary publication/regulatory sources checked or consulted: dc23-1096.

09. imatinib-immunotherapy — Imatinib (tyrosine kinase inhibitor)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Imatinib randomized primary outcome used a one-sided test; benefit at 12 months not sustained 24 months. Frequent dose modification/discontinuation supports restrained safety interpretation.
• Registry NCT01781975: COMPLETED; updated 2020-02-11; enrollment 67 (ACTUAL); primary completion 2017-05 (ACTUAL); results posted.
• Primary publication/regulatory sources checked or consulted: S2213-8587%2821%2900139-X; 021588s060lbl.pdf.

10. low-dose-atg-prevention — Low-dose anti-thymocyte globulin (ATG)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: MELD-ATG paper verified doses 0.5/2.5 mg/kg, serum sickness 32%/82%, cytokine release 24%/33%. Updated ASCEND to recruiting on 9 September, n 60, Nov 2029 estimated completion; removed old registry/site disagreement.
• Registry NCT04291703: TERMINATED; updated 2026-05-07; enrollment 2 (ACTUAL); primary completion 2024-12-17 (ACTUAL); results posted.
• Registry NCT07216391: RECRUITING; updated 2026-09-09; enrollment 60 (ESTIMATED); primary completion 2029-11-30 (ESTIMATED); results not posted in retrieved record.
• Registry NCT02215200: COMPLETED; updated 2020-03-02; enrollment 89 (ACTUAL); primary completion 2017-08 (ACTUAL); results posted.
• Registry NCT04509791: COMPLETED; updated 2025-01-10; enrollment 114 (ACTUAL); primary completion 2024-12-16 (ACTUAL); results not posted in retrieved record.
• Registry NCT00515099: TERMINATED; updated 2017-05-11; enrollment 58 (ACTUAL); primary completion 2012-06 (ACTUAL); results posted.
• Primary publication/regulatory sources checked or consulted: dc18-0494; db19-0057; S0140-6736%2825%2901674-5; S2213-8587%2813%2970065-2; db16-0823; bmjopen-2021-053669; dc15-1419; dbi20-0054.
• Programme/sponsor/conference source boundary: ATG and Teplizumab Comparative Prevention Study (ASCEND T1D) (registry).

11. low-dose-il2-prevention — Low-dose interleukin-2 (IL-2)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Low-dose IL2 dose-finding expands Tregs; subgroup preservation does not establish clinical onset delay. Current engineered-IL2 and aldesleukin registries remain recruiting; no posted efficacy.
• Registry NCT07142252: RECRUITING; updated 2026-09-08; enrollment 66 (ESTIMATED); primary completion 2028-05-25 (ESTIMATED); results not posted in retrieved record.
• Registry NCT05153070: RECRUITING; updated 2026-09-09; enrollment 24 (ESTIMATED); primary completion 2027-11-29 (ESTIMATED); results not posted in retrieved record.
• Registry NCT01353833: COMPLETED; updated 2012-04-23; enrollment 25 (ACTUAL); primary completion 2011-10 (ACTUAL); results not posted in retrieved record.
• Registry NCT01862120: COMPLETED; updated 2020-11-12; enrollment 24 (ACTUAL); primary completion 2016-07-08 (ACTUAL); results not posted in retrieved record.
• Registry NCT03782636: ACTIVE_NOT_RECRUITING; updated 2025-10-03; enrollment 41 (ACTUAL); primary completion 2023-02-16 (ACTUAL); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: dbi20-0054; s11892-014-0553-6; S2213-8587%2813%2970113-X; journal.pmed.1002139; jci.insight.99306; s00125-020-05200-w; wellcomeopenres.15697.1; jci.insight.147474.

12. oral-insulin-immunotherapy — Oral insulin (antigen-specific immunotherapy)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: POInT primary endpoint neutral HR 1.12; genotype interactions hypothesis-generating. Corrected blanket zero-hypoglycemia claim: rare glucose <50 mg/dL measurements occurred in both arms. No general prevention indication.
• Registry NCT00419562: COMPLETED; updated 2020-05-07; enrollment 560 (ACTUAL); primary completion 2016-12 (ACTUAL); results posted.
• Registry NCT03364868: COMPLETED; updated 2024-10-08; enrollment 1050 (ACTUAL); primary completion 2024-06-28 (ACTUAL); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: dc15-1419; jama.2013.6285; bmjopen-2016-011144; S0140-6736%2825%2901726-X; jama.2015.2928; diacare.28.5.1068; jama.2017.17070.

13. rituximab-prevention — Rituximab (anti-CD20)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Rituximab initial C-peptide effect and 8.2-month lag checked; RELAY combination remains active follow-up with no posted outcomes. No prevention approval.
• Registry NCT00279305: COMPLETED; updated 2020-05-06; enrollment 87 (ACTUAL); primary completion 2009-04 (ACTUAL); results posted.
• Registry NCT03929601: ACTIVE_NOT_RECRUITING; updated 2026-09-01; enrollment 74 (ACTUAL); primary completion 2027-03-31 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: PMID 19940299; PMID 24026563; PMID 26404926.

14. selective-jak-inhibitors — Selective JAK inhibitors (abrocitinib / ritlecitinib)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: JAKPOT current registry Sep 2 moves estimated primary completion to 30 October 2026 and final 30 October 2027; updated stale June timing. No posted T1D efficacy.
• Registry NCT05743244: ACTIVE_NOT_RECRUITING; updated 2026-09-02; enrollment 78 (ESTIMATED); primary completion 2026-10-30 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: 213871s000lbl.pdf.

15. siplizumab-anti-cd2 — Siplizumab (anti-CD2)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: DESIGNATE/STRIDE terminated records and posted immune/safety tables support no interpretable clinical-preservation result and significant lymphodepletion concern. No restart found.
• Registry NCT05574335: TERMINATED; updated 2026-07-28; enrollment 8 (ACTUAL); primary completion 2025-05-14 (ACTUAL); results posted.
• Registry NCT06025110: TERMINATED; updated 2025-08-14; enrollment 9 (ACTUAL); primary completion 2025-07-24 (ACTUAL); results not posted in retrieved record.

16. teplizumab — Teplizumab (Tzield)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Replaced stage 2-only April FDA label URL with June current US label. Verified stage 2 age 1+, jurisdiction-specific age 8+ elsewhere; added boxed viral-reactivation warning/contraindications and funding distinction. Stage 3 is separate item. PBS July rejection/NICE implementation dates are reimbursement claims, not efficacy.
• Registry NCT01030861: COMPLETED; updated 2020-08-05; enrollment 76 (ACTUAL); primary completion 2018-11 (ACTUAL); results posted.
• Registry NCT03875729: COMPLETED; updated 2024-04-24; enrollment 328 (ACTUAL); primary completion 2023-05-01 (ACTUAL); results posted.
• Registry NCT07088068: RECRUITING; updated 2026-09-14; enrollment 723 (ESTIMATED); primary completion 2028-06-06 (ESTIMATED); results not posted in retrieved record.
• Registry NCT05757713: ACTIVE_NOT_RECRUITING; updated 2026-01-30; enrollment 20 (ESTIMATED); primary completion 2026-08-27 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: NEJMoa1902226; scitranslmed.abc8980; NEJMoa2308743; s40265-023-01847-y; dbi20-0054; tzield.pdf; pbac-web-outcomes-07-2026-v1.pdf; tzield-teplizumab; tzield; teplizumab-to-delay-the-onset-of-type-1-diabetes-recommended; ta1176; jama.2013.6285.
• Programme/sponsor/conference source boundary: Sanofi's Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes (manufacturer); Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children (manufacturer); Sanofi's Teizeild approved in the EU for patients with stage 2 type 1 diabetes (manufacturer); MHRA approves teplizumab to delay progression of type 1 diabetes (regulatory).

17. ustekinumab-immunotherapy — Ustekinumab (IL-12/23 p40 blocker)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Ustekinumab adolescent randomized 12-month signal checked; adult trial remains a test of generalizability. No prevention or T1D approval.
• Registry NCT03941132: ACTIVE_NOT_RECRUITING; updated 2025-02-24; enrollment 66 (ESTIMATED); primary completion 2026-02-01 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: s41591-024-03115-2; 761044s010lbl.pdf.

18. verapamil — Verapamil (oral)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Pediatric verapamil RCT modest C-peptide preservation and exploratory off-drug loss checked; bradycardia/AV block monitoring remains relevant. No approved T1D disease-modifying indication.
• Registry NCT02372253: COMPLETED; updated 2020-02-05; enrollment 32 (ACTUAL); primary completion 2017-12 (ACTUAL); results posted.
• Registry NCT04233034: COMPLETED; updated 2024-11-27; enrollment 113 (ACTUAL); primary completion 2022-09-15 (ACTUAL); results posted.
• Registry NCT04545151: COMPLETED; updated 2026-05-20; enrollment 136 (ACTUAL); primary completion 2025-04-23 (ACTUAL); results not posted in retrieved record.
• Registry NCT07061574: RECRUITING; updated 2026-09-02; enrollment 120 (ESTIMATED); primary completion 2030-04-15 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: s41467-022-28826-3; jama.2023.2064; bmjopen-2024-091597; s00125-024-06205-5; 000525824.

19. ask-screening-program — ASK (Autoimmunity Screening for Kids)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Official ASK site now includes all US children 1–17 AND adults; locations page offers home collection and remote Labcorp kits. Updated eligibility, sampling, access and resolved home-kit upcoming claim. Published screening evidence does not prove kit-specific DKA efficacy.
• Primary publication/regulatory sources checked or consulted: j.ypmed.2026.108625; 761183s013lbl.pdf.
• Programme/sponsor/conference source boundary: ASK Research Program — current eligibility (registry); ASK screening locations and collection options (registry).

20. australia-national-screening-pilot — Australian T1D National Screening Pilot

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Pilot protocol compares three screening models, with genetic enrichment distinct from antibody diagnosis. Corrected claim that no general-population screen can be requested: Type1Screen now offers wider access. School pilot and system investment remain research, not universal service.
• Primary publication/regulatory sources checked or consulted: PMID 39129150.
• Programme/sponsor/conference source boundary: Type 1 Diabetes National Screening Pilot (official study site) (registry); Australian Type 1 Diabetes National Screening Pilot: advancing the evidence base towards national public health implementation (manufacturer); National T1D screening supported with nearly $10m from Breakthrough T1D (manufacturer).

21. autoantibody-screening — Islet autoantibody screening (GADA, IA-2A, ZnT8A, IAA)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Added 10 September 2026 peer-reviewed general-population consensus with ages 2–4, 6–8, 10–15 and required follow-up. Primary full text disagrees with convening-body announcement on middle age band (announcement 4–6); used 6–8. Historical staging/progression and assay-standardization evidence retained.
• Primary publication/regulatory sources checked or consulted: s00125-026-06841-z; dc15-1419; jama.2013.6285; jama.2019.21565; s00125-023-05953-0; dc21-0422; dci24-0042; dc19-2003; j.ypmed.2026.108625; dom.70569; dc25-1326.

22. cascade-kids-screening — CASCADE (Cascade Kids newborn screening)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Cascade Kids official programme uses residual Washington newborn cards followed by risk-based monitoring; no evidence it is a permanent nationwide funded service. Genetic risk is not a diagnosis.
• Programme/sponsor/conference source boundary: TEDDY and CASCADE: Type 1 Diabetes Research Studies (manufacturer); Newborn Screening Research — CASCADE study (regulatory).

23. d1ce-screen-italy — D1Ce Screen / Italy national screening (Law 130/2023)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: D1Ce pilot/statutory framework and staged implementation distinguished. Nationwide operational launch not verified; secondary implementation-decree reporting is weaker than statute/protocol evidence. No confident claim of universal availability added.
• Primary publication/regulatory sources checked or consulted: dom.16611.
• Programme/sponsor/conference source boundary: The D1Ce Screen project — Istituto Superiore di Sanità (regulatory).

24. edent1fi-screening — EDENT1FI (European early-detection consortium)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: EDENT1FI official consortium scale and master-protocol rationale reviewed; consensus and harmonization do not establish each local programme active today or permanent reimbursement.
• Primary publication/regulatory sources checked or consulted: dom.70569.

25. elsa-screening-program — ELSA (EarLy Surveillance for Autoimmune diabetes)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Official NHS ELSA page explicitly says currently paused. Changed available status/access score/summary/display; age 2–17 remains design eligibility. Removed fixed 10–15 year prediagnostic antibody lead-time; no reopening date assumed.
• Primary publication/regulatory sources checked or consulted: teplizumab-to-delay-the-onset-of-type-1-diabetes-recommended; ta1176; PMID 41576975; PMID 31180194.
• Programme/sponsor/conference source boundary: The ELSA Study — current participation status (registry); Type 1 Diabetes: Infant Testing — Hansard, House of Commons (regulatory); Type 1 Diabetes Screening (Children) Bill — UK Parliament (regulatory).

26. fr1da-screening-program — Fr1da (German General-Population T1D Screening)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: JAMA 2026 cohort 220,476, five-year progression 36.2% and no family-history difference checked. Corrected initial DKA denominator: 280 screen-positive children were not 280 clinical diabetes diagnoses. No programme-wide near-zero-risk guarantee.
• Registry NCT04039945: RECRUITING; updated 2024-12-17; enrollment 285000 (ESTIMATED); primary completion 2028-12 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: jama.2026.6085.

27. genetic-risk-screening — Genetic risk score (GRS) newborn screening

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: GRS2 discrimination is population-level; high score is neither disease diagnosis nor deterministic outcome. POInT result reinforces separation of enrichment from prevention efficacy.
• Registry NCT03364868: COMPLETED; updated 2024-10-08; enrollment 1050 (ACTUAL); primary completion 2024-06-28 (ACTUAL); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: dc18-1785; S0140-6736%2825%2901726-X; PMID 26404926; jama.2013.6285; s00125-023-05953-0.

28. oral-glucose-tolerance-test — Oral glucose tolerance test (OGTT) for T1D staging

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: 2024 monitoring consensus supports OGTT as metabolic staging test, not a convenient first-line general-population antibody screen. No result/treatment conflation.
• Registry NCT00097292: RECRUITING; updated 2025-07-01; enrollment 75000 (ESTIMATED); primary completion 2030-07-31 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: dci24-0042.

29. pledge-screening-program — PLEDGE (Sanford general-population screening)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: PLEDGE official study pages support Sanford footprint, research/free offer and coupled genetic/antibody approach. No published outcome upgrade or universal US availability inferred.
• Registry NCT04477928: RECRUITING; updated 2026-03-02; enrollment 33000 (ESTIMATED); primary completion 2031-03 (ESTIMATED); results not posted in retrieved record.
• Programme/sponsor/conference source boundary: PLEDGE Pediatric Screening Study (manufacturer).

30. t1detect-screening — T1Detect (Breakthrough T1D at-home autoantibody screening)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.

• Claim check: Current T1Detect ordering, price, financial assistance and shipping could not be verified from live primary ordering source. Recast old launch terms as historical, access unverified and link verified ASK alternative. Removed stale future age 1 teplizumab expansion; fixed FDA label URL. Assay validation from other DBS platforms is not proof of current kit performance.

• Primary publication/regulatory sources checked or consulted: journal.pone.0242049; dc15-1419; jama.2013.6285; jama.2019.21565; dme.70071; dia.2023.0345; dc24-2443; tzield.pdf; 761183s013lbl.pdf.

• Follow-up link check: former T1Detect landing page returned 404; removed it and its unverified current-panel attribution. The December 2020 launch announcement remains indexed historical evidence, explicitly not a current offer. Consolidated teplizumab labeling to correctly titled June 2026 prescribing information.

31. t1dra-adult-screening — T1DRA (Type 1 Diabetes Risk in Adults)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.

• Claim check: T1DRA official site search-index text supports free UK age 18–70 home testing and consent route; direct homepage fetch failed (index 2 months old). Corrected claim that US adult route is T1Detect and no other country adult route; ASK/Type1Screen are verified alternatives. Current direct recruitment confirmation remains limited.

• Primary publication/regulatory sources checked or consulted: teplizumab-to-delay-the-onset-of-type-1-diabetes-recommended; dom.70569.

• Programme/sponsor/conference source boundary: T1DRA — Type 1 Diabetes Risk in Adults (official study site) (official study programme).

• Retrieval limit (not a falsity finding): https://t1dra.bristol.ac.uk/.

• Follow-up access check: direct homepage timed out and consent page returned 502; indexed eligibility/consent/news pages were two to four months old. Public summary, status, access score and availability labels now say current recruitment is unconfirmed. Removed unsupported worldwide-exclusive screening claims and identified ASK/Type1Screen alternatives. Study consent page, eligibility and news were available through indexed text only.

32. trialnet-pathway-to-prevention — TrialNet Pathway to Prevention

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: TrialNet eligibility/network and historical cohort/monitoring publications checked. Zero DKA in one Italian cohort is not a universal guarantee; risk models require recalibration across populations. No changed eligibility claim added.
• Registry NCT00097292: RECRUITING; updated 2025-07-01; enrollment 75000 (ESTIMATED); primary completion 2030-07-31 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: dc15-1419; jama.2013.6285; dc25-0192; s00125-025-06461-z; dgac594; NEJMoa1902226; download; 761183s013lbl.pdf; s00125-025-06434-2; s12916-025-04225-5.

33. type1screen-australia — Type1Screen (Australia)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Current official funder page broadens free Type1Screen to anyone in Australia over 1. Updated summary/eligibility/access/card/body, keeping earlier relatives-cohort 2.1% yield and 12 progressions without DKA separate from wider population.
• Primary publication/regulatory sources checked or consulted: PMID 39879258.
• Programme/sponsor/conference source boundary: Type1Screen — diabetes autoantibody screening (official site) (manufacturer); Type1Screen: free screening for early-stage type 1 diabetes in Australia (manufacturer).

34. celregen-crg-002-islets — Celregen CRG-002 iPSC-derived islets

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: CRG-002 remains invitation-only, n=10, with estimated January 2028 primary completion. The existing EASD abstract is conference-level evidence, scheduled for 29 September; it is not a completed presentation or peer-reviewed paper. The dynamic abstract could not be fully retrieved in this pass.
• Registry NCT07503028: ENROLLING_BY_INVITATION; updated 2026-08-26; enrollment 10 (ESTIMATED); primary completion 2028-01-18 (ESTIMATED); results not posted in retrieved record.
• Programme/sponsor/conference source boundary: First-in-human transplantation of CRG-002, an iPSC-derived universal islet product for type 1 diabetes (conference).

35. cipsc-islets-rgb-5088 — CiPSC-derived autologous islets (RGB-5088)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: The published CiPSC recipient achieved insulin independence while already immunosuppressed; registry endpoints are not results. Removed the false claim that Sana treated the only human ever to carry an insulin-producing graft without drugs. Autologous origin does not establish protection from recurrent autoimmunity.
• Registry NCT06731218: RECRUITING; updated 2025-09-15; enrollment 10 (ESTIMATED); primary completion 2027-12-31 (ESTIMATED); results not posted in retrieved record.
• Registry NCT07464119: NOT_YET_RECRUITING; updated 2026-03-11; enrollment 30 (ESTIMATED); primary completion 2028-12-31 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: j.cell.2024.09.004; 09636897251366828.

36. donor-islet-transplant — Donor islet transplant (Lantidra / donislecel)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: FDA SBRA and label directly checked: Lantidra approval used UIH-001/UIH-002 (30 participants), distinct from CIT-07 (48). Added primary citations and explicit separation. FDA reports 21 insulin-independent for at least one year, 10 beyond five years, 90% with a serious adverse reaction and two deaths during follow-up. Corrected bleeding/liver-complication denominator from infusions to recipients (13%). Removed unsupported numerical annual access ceiling.
• Registry NCT00434811: COMPLETED; updated 2019-07-17; enrollment 48 (ACTUAL); primary completion 2012-09 (ACTUAL); results not posted in retrieved record.
• Registry NCT04786262: RECRUITING; updated 2026-09-01; enrollment 57 (ESTIMATED); primary completion 2027-12-31 (ESTIMATED); results not posted in retrieved record.
• Registry NCT00679042: ACTIVE_NOT_RECRUITING; updated 2026-04-06; enrollment 21 (ACTUAL); primary completion 2017-07-19 (ACTUAL); results posted.
• Primary publication/regulatory sources checked or consulted: download; download; PMID 41219164; fda-approves-first-cellular-therapy-treat-patients-type-1-diabetes; PMID 27208344; PMID 40544428; TXD.0000000000001960.

37. e-islet-01 — E-islet 01 allogeneic human regenerative islets

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: The current E-islet 01 trial is distinct from the 2026 three-recipient T1D publication and 2024 T2D kidney-recipient case. DOI/title metadata were verified, but the full 2026 case letter was inaccessible in this pass. No drug-free benefit or posted trial results were inferred.
• Registry NCT07126873: RECRUITING; updated 2025-08-22; enrollment 21 (ESTIMATED); primary completion 2027-12-31 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: S2213-8587%2825%2900423-1; s41421-024-00662-3.

38. newcelx-ncel101-isletrx — NewcelX NCEL-101 / IsletRx

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: NewcelX/IsletRx primary corporate materials describe pre-IND consultation. A meeting is not IND clearance, and does not demonstrate human efficacy or establish an approval date.
• Programme/sponsor/conference source boundary: NewcelX pipeline: IsletRx / NCEL-101 for type 1 diabetes (manufacturer); NewcelX submits pre-IND package to FDA for NCEL-101 for type 1 diabetes (manufacturer); NewcelX announces strategic collaboration with Eledon to advance NCEL-101 program for type 1 diabetes (manufacturer); NewcelX Announces Successful FDA Pre-IND Meeting with Clear Path Forward for NCEL-101 Toward Starting Clinical Trials for Type 1 Diabetes (manufacturer).

39. orizuru-oztx-410-islet-sheet — OZTx-410 allogeneic iPSC islet cell sheet (Orizuru)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: The Japanese jRCT record confirms OZT-410 is not recruiting, with three planned recipients aged 20 to under 65. That status does not demonstrate insulin independence or efficacy.
• Programme/sponsor/conference source boundary: Phase 1/1b trial to evaluate the safety of OZTx-410, allogeneic iPS cell derived islet cell sheet in individuals with type 1 diabetes eligible for pancreatic islet transplantation (OASiS-1; jRCT2053240146) (registry).

40. seraxis-sr-02-islets — Stem-cell-derived islet clusters (Seraxis SR-02)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: SR-02 registry design and sponsor first-recipient reporting were reviewed. No quantitative peer-reviewed efficacy was located. Selection for severe hypoglycemia and the need for immunosuppression remain limits.
• Registry NCT07581197: NOT_YET_RECRUITING; updated 2026-05-12; enrollment 9 (ESTIMATED); primary completion 2028-11 (ESTIMATED); results not posted in retrieved record.
• Programme/sponsor/conference source boundary: Seraxis Announces FDA IND Allowance for Clinical Study of SR-02 Replacement Islets for Type 1 Diabetes (manufacturer).

41. stem-cell-islets — Stem-cell-derived islets (zimislecel / VX-880)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Updated the 1 September NCT04786262 master protocol: VX-880 Phase 1/2/3 plus VX-017 Phase 1/2; 57 estimated participants total; December 2027 primary completion and December 2031 final completion; hepatic portal infusion. Kept VX-880's NEJM n=12 result separate from unreported VX-017 outcomes.
• Registry NCT04786262: RECRUITING; updated 2026-09-01; enrollment 57 (ESTIMATED); primary completion 2027-12-31 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: NEJMoa2506549.

42. tuff-ipc-adipose-islets — TUFF-IPC autologous adipose-derived insulin-producing cells

• Disposition: corrected/updated. Current item lastReviewed: 2026-08-27T00:00:00.000Z.
• Claim check: The jRCT full eligibility criteria explicitly allow ages 18–65 inclusive. Corrected “under 65” wording. This is a recruiting first-in-human study with target n=3, not evidence of efficacy.
• Programme/sponsor/conference source boundary: jRCT2063250055 — investigator-initiated FIH of autologous adipose-derived insulin-producing cells in type 1 diabetes (registry).

43. vx-017-blood-type-independent-islets — VX-017 blood-type-independent stem-cell islets

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: VX-017 is now Part D of the recruiting master protocol. Updated maturity, display, route, eligibility and citation. Registration does not establish dosing, outcomes, immune-evasion design or a drug-free regimen. Unverified blood-group and C-peptide restrictions were not added.
• Registry NCT04786262: RECRUITING; updated 2026-09-01; enrollment 57 (ESTIMATED); primary completion 2027-12-31 (ESTIMATED); results not posted in retrieved record.
• Programme/sponsor/conference source boundary: Vertex reports second-quarter 2026 financial results (manufacturer).

44. beta-o2-bair-bioartificial-pancreas — Beta-O2 ßAir bioartificial pancreas (oxygen-refueled macrocapsule)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: BetaAir's four-recipient Phase 1 showed protected cells without immunosuppression, but insufficient insulin output and no clinically effective glucose benefit. Daily oxygen refills and the small study remain limitations.
• Registry NCT02064309: ACTIVE_NOT_RECRUITING; updated 2026-04-28; enrollment 4 (ACTUAL); primary completion 2027-05 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: ajt.14642.

45. encellin-encapsulation — Encellin thin-film cell encapsulation (ENCRT / ENC-201)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.

• Claim check: ENC-103/ENC-201 registry design and status were reviewed. Immune protection and insulin independence are intended outcomes, not demonstrated clinical benefits. No controlled efficacy report was located.

• Registry NCT06408311: ACTIVE_NOT_RECRUITING; updated 2026-03-11; enrollment 10 (ESTIMATED); primary completion 2026-07-31 (ESTIMATED); results not posted in retrieved record.

• Primary publication/regulatory sources checked or consulted: PMID 25950860; PMID 28763191; PMID 28632821.

• Follow-up source correction: the two dead company /news/ URLs moved to /blog/. January company report distinguishes five explants from viable islets in the initial evaluated explant. July ISSCR release reports seven enrolled, non-fibrotic engraftment across seven and islets in multiple participants. Updated item and distinguished the registry estimate of 10 from reported enrollment of seven. These remain interim sponsor/society observations, not controlled efficacy or insulin-independence proof. Removed a redundant secondary citation and unsupported comparative-safety wording. December 2023 financing source remains corporate evidence.

46. itolerance-itol-102-safasl-microgel — iTolerance iTOL-102 (SA-FasL microgel + islets)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: The SA-FasL primate experiment used a small cohort and temporary rapamycin; it is not the proposed iTOL-102 stem-cell product. Removed the inference that FDA sent the company back: pre-IND consultation is not authorization. Removed the false exclusive-human-benchmark claim.
• Registry NCT03482050: COMPLETED; updated 2021-01-15; enrollment 16 (ACTUAL); primary completion 2020-06-22 (ACTUAL); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: sciadv.abm9881.
• Programme/sponsor/conference source boundary: Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment (manufacturer); iTolerance — iTOL-100 platform and pipeline (iTOL-101, iTOL-102) (manufacturer); NLS Pharmaceutics and Kadimastem Highlight Continued BIRD Foundation Support for ITOL-102 Diabetes Program Following Merger (manufacturer).

47. mit-oxygen-generating-encapsulation — MIT oxygen-generating encapsulation device (self-oxygenating islet implant)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Corrected “rodent-only”: the Device paper also reports one-month islet survival in a nonhuman primate without immunosuppression. No human benefit was shown. Removed unsupported attribution of VX-264 failure to the same mechanism.
• Primary publication/regulatory sources checked or consulted: j.device.2026.101084.

48. opf-310-porcine-islets — OPF-310 encapsulated porcine islets

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: The current OPF-310 registry allows ages 35–70, not 35–65. Corrected eligibility. The recruiting first-in-human porcine encapsulation trial has no reported efficacy; protection from xenograft rejection remains a test.
• Registry NCT06575426: RECRUITING; updated 2026-08-21; enrollment 13 (ESTIMATED); primary completion 2027-06-30 (ESTIMATED); results not posted in retrieved record.

49. sernova-bio-hybrid-organ — Sernova Cell Pouch Bio-hybrid Organ

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: The September 2024 sponsor source explicitly says all six insulin-independent Cohort A recipients received combined pouch and intraportal transplantation. Added that qualifier directly beside summary, criterion and 6/6 body claims. Interim 8/12 and long-lived tissue remain sponsor reports; neither establishes the pouch-alone effect. Chronic immunosuppression and funding-dependent Cohort C remain limits.
• Registry NCT03513939: ACTIVE_NOT_RECRUITING; updated 2026-02-25; enrollment 17 (ESTIMATED); primary completion 2026-10 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: TP.0000000000000864; ajt.14547.

50. sig-002-lilly-sigilon-encapsulated-islets — SIG-002 (Lilly/Sigilon Afibromer-encapsulated islets)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Lilly/Sigilon primary corporate/SEC history and SIG-001 registry were reviewed. Hemophilia-platform failure does not prove SIG-002 failure, and silence does not prove cancellation. Removed the false assertion that only one person ever carried an insulin-producing graft without immunosuppression.
• Registry NCT04541628: TERMINATED; updated 2024-09-04; enrollment 3 (ACTUAL); primary completion 2022-10-28 (ACTUAL); results posted.
• Programme/sponsor/conference source boundary: Lilly to Acquire Sigilon Therapeutics (manufacturer); Lilly and Sigilon Therapeutics Announce Strategic Collaboration to Develop Encapsulated Cell Therapies for the Treatment of Type 1 Diabetes (manufacturer); Lilly Clinical Development Pipeline (manufacturer).

51. vertex-vx-264-encapsulated-islets — Vertex VX-264 (device-encapsulated stem-cell islets)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: VX-264 was discontinued after insufficient C-peptide production. Active registry follow-up does not restart the programme. Removed speculative hypoxia/fibrosis causation and claims that safety was proved; sponsor-reported early tolerability is not a definitive safety conclusion.
• Registry NCT05791201: ACTIVE_NOT_RECRUITING; updated 2026-09-10; enrollment 7 (ACTUAL); primary completion 2027-03-12 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: NEJMoa2506549; db25-0037.

52. vicapsys-cxcl12-alginate-encapsulation — ViCapsys / MGH CXCL12-alginate islet encapsulation (VICAPSYN)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Primate papers show small pilot studies, reduced islet viability and C-peptide detectable through 13 weeks, not insulin independence. Corrected contradictory claims that no animal achieved insulin independence and every study was drug-free: mouse glycemic correction occurred, and the NOD combination used costimulation blockade.
• Primary publication/regulatory sources checked or consulted: xen.70098; xen.12826; TXD.0000000000000890; ajt.15308; ajt.13049; xen.12577; j.pharmthera.2018.08.011.

53. aspect-bioprinted-islet-tissue — Aspect Biosystems bioprinted islet tissue (ex-Novo Nordisk platform)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Aspect's 2022 poster used rat islets and a chemical diabetes model; the later-acquired hypoimmune component has no combined human proof. Current pipeline stage is undisclosed. Removed the false exclusive Sana human benchmark.
• Programme/sponsor/conference source boundary: Aspect Biosystems and Novo Nordisk enter new phase of partnership to develop curative medicines for diabetes (manufacturer); "816-P: Bioprinted Allogeneic Islet-Containing Implants Normalize Blood Glucose Control in Diabetic Rat Models without Immune Suppression" (conference); Aspect Biosystems to Present on Pancreatic Tissue Therapeutic at American Diabetes Association 82nd Scientific Sessions (manufacturer); Pipeline of Bioprinted Tissue Therapeutics — Aspect Biosystems (manufacturer).

54. century-cnty-813-allo-evasion — Century Therapeutics CNTY-813 (Allo-Evasion 5.0 iPSC islets)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Century's company and ADA evidence is preclinical. Q4 2026 IND and second-half 2027 first-data guidance remain plans. Future October presentations were not counted as completed results; no human CNTY-813 outcomes were located.
• Primary publication/regulatory sources checked or consulted: NEJMc2604408.
• Programme/sponsor/conference source boundary: New CNTY-813 Preclinical Data Demonstrate Durable Glucose Control, Immune Evasion Under Alloimmune Pressure, and Scalable Manufacturing at ADA 2026 (manufacturer); Century Therapeutics Reports First Quarter 2026 Financial Results and Business Updates (manufacturer); Century Therapeutics Selected for Oral Presentations of CNTY-813 Preclinical Data at EASD 2026 and Breakthrough T1D Clinical & Research Congress 2026 (manufacturer); Century Therapeutics pipeline — CNTY-813, beta islet cells (Allo-Evasion 5.0) (manufacturer).

55. genprex-gpx002-pdx1-mafa-reprogramming — Genprex GPX-002 (AAV Pdx1 + MafA alpha-to-beta reprogramming)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Genprex mouse papers support alpha-cell reprogramming but show recurrent autoimmunity after about four months in NOD mice. Primate work and company timelines remain development claims; no human T1D efficacy was located.
• Primary publication/regulatory sources checked or consulted: PMID 29304344; PMID 36879848.
• Programme/sponsor/conference source boundary: Diabetes Gene Therapy — GPX-002 (Genprex program page) (manufacturer); Genprex Provides Clinical Update on Diabetes Gene Therapy Program (manufacturer); Genprex Collaborators Present Positive Preclinical Data on Diabetes Gene Therapy for Type 2 Diabetes at the 2026 American Society of Gene and Cell Therapy Annual Meeting (manufacturer).

56. immunostem-pdl1-hspc — IMMUNOSTEM PD-L1 HSPC gene therapy

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: IMMUNOSTEM remains not yet recruiting after its estimated 2025 start. Mouse PD-L1 restoration does not establish human immune tolerance, durability or conditioning requirements. No human outcome was located.
• Registry NCT06938334: NOT_YET_RECRUITING; updated 2025-04-22; enrollment 15 (ESTIMATED); primary completion 2029-06-15 (ESTIMATED); results not posted in retrieved record.
• Programme/sponsor/conference source boundary: Altheia Science — PD-L1 HSPC technology (manufacturer); Altheia Science publications: PD-L1 overexpression in HSPCs and autoimmune diabetes (manufacturer).

57. kriya-839-aav-insulin-glucokinase — Kriya muscle-directed AAV gene therapy (current KRIYA.288 programme)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: Rewritten around current KRIYA.288 glucokinase payload. Identity with historical KRIYA-839 insulin-plus-glucokinase is not established. The sponsor's Phase 1/2 label lacks a located public T1D registration; a sponsor query found four non-T1D studies. Removed unverified PROGRESS eligibility and start promises.
• Primary publication/regulatory sources checked or consulted: PMID 23378612.
• Programme/sponsor/conference source boundary: KRIYA.288 Type 1 Diabetes — current programme specifications (manufacturer).
• Retrieval limit (not a falsity finding): https://doi.org/10.2337/db23-855-P.

58. minutia-hypoimmune-islets — Minutia (gene-edited hypoimmune islets + graft nanosensors)

• Disposition: corrected/updated. Current item lastReviewed: 2026-08-27.
• Claim check: Minutia's CIRM/NIH awards and preclinical descriptions are funding and design evidence, not clinical efficacy. Removed exclusive-human-benchmark wording. No IND or trial was located; unsuccessful searches are not proof of worldwide absence.
• Primary publication/regulatory sources checked or consulted: NEJMc2604408.
• Programme/sponsor/conference source boundary: Minutia | A Next Generation Cell Therapy Company (manufacturer); Bioengineering human stem cell-derived beta cell organoids to monitor cell health in real time and improve therapeutic outcomes in patients (CIRM DISC2-13498) (registry).

59. sana-sc451-hypoimmune — Sana Biotechnology SC451 (hypoimmune stem-cell islets)

• Disposition: corrected after additional opening-summary and ranking QA; current item lastReviewed: 2026-09-16.

• Claim check: Distinguished UP421 donor-islet proof from the still-pre-IND SC451 iPSC product. The first NEJM case and July letter/sponsor follow-up concern one low-dose recipient who remained on insulin. Full July letter retrieval was limited; sponsor details remain attributed rather than treated as an independent full-paper review.

• Registry NCT06239636: RECRUITING; updated 2024-12-11; enrollment 2 (ESTIMATED); primary completion 2025-05 (ESTIMATED); results not posted in retrieved record.

• Primary publication/regulatory sources checked or consulted: NEJMc2604408; PMID 40757665; 09636897251394787; s41587-019-0016-3.

• Programme/sponsor/conference source boundary: Sana Biotechnology Announces Follow-On Publication in the New England Journal of Medicine Highlighting Long-Term Data and Durability of Hypoimmune-Modified Islet Cell Transplantation Without Immunosuppression in Type 1 Diabetes (manufacturer); Sana Biotechnology and Mayo Clinic Announce Strategic Collaboration Focused on Improving Care in Type 1 Diabetes and Accelerating Development of SC451 (manufacturer).

• Additional correction: evidence badge now preclinical; all six criteria and their scores apply to SC451 itself. Removed inherited UP421 age and treatment regions, unsupported strongest/longest comparisons, and claims that immune evasion is proven for SC451. UP421 clinical observations remain explicitly separate context. Detailed July follow-up is attributed to the company because full letter retrieval remained limited.

• Fresh primary status evidence: Sana 10 August 2026 Q2 update describes preparation for IND and Phase 1/2; SC451 registry name search repeated 16 September returned 0. Search absence is not worldwide proof; stage 0 was retained from primary development evidence, not inferred from calendar dates.

60. vertex-vctx211-gene-edited — CRISPR Therapeutics hypoimmune islets (CTX211 → CTX213)

• Disposition: corrected after additional opening-summary and ranking QA; current item lastReviewed: 2026-09-16.

• Claim check: CTX211's five-participant trial remains terminated. Sponsor-reported detectable C-peptide at 12 months is unquantified; successor CTX213 is preclinical. CAR-T immune-evasion papers provide platform context, not CTX211 islet outcomes. Protocol exclusion of chronic immunosuppression does not document every recipient's full treatment course.

• Registry NCT05565248: TERMINATED; updated 2026-05-07; enrollment 5 (ACTUAL); primary completion 2025-08-08 (ACTUAL); results not posted in retrieved record.

• Registry NCT05210530: COMPLETED; updated 2023-06-26; enrollment 7 (ACTUAL); primary completion 2023-01-19 (ACTUAL); results not posted in retrieved record.

• Primary publication/regulatory sources checked or consulted: s41467-023-37785-2; j.stem.2025.07.009.

• Programme/sponsor/conference source boundary: CRISPR Therapeutics Highlights Strategic Priorities and Anticipated 2026 Milestones (manufacturer); CRISPR Therapeutics Provides Business Update and Reports First Quarter 2026 Financial Results (manufacturer); CRISPR Therapeutics pipeline — CTX213 (Regenerative Medicine) (manufacturer).

• Additional correction: public name and scoring scope now identify current CTX213; evidence badge preclinical, all criteria rebuilt around successor-specific uncertainty. Removed predecessor age/access fields, inferred all-five drug-free treatment course, and inherited device-retrieval safety benefit. Stage 0 unchanged.

• Newly inspected 3 August 2026 company presentation, slide 41 adds sponsor-reported CTX211 no serious adverse events or adverse events of special interest, 12-month C-peptide and histologic insulin-cell survival despite device fibrosis and immune infiltration. This supersedes the earlier ledger’s narrow description of one unquantified press-release sentence; it is not peer-reviewed full clinical results, nor CTX213 human evidence. CTX213 rat findings are preclinical.

• 3 August Q2 update supports current preclinical status. CTX213 registry name search repeated 16 September returned 0; no worldwide absence inferred.

61. asiti-201-proinsulin-liposome — ASITI-201 (proinsulin peptide / calcitriol liposomes)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27T00:00:00.000Z.
• Claim check: The 2 July ANZCTR update reports Part A complete and Part B recruiting, with 36 planned and 27 accrued. UQ's first-dose announcement is not an outcome table. Adult, HLA and residual C-peptide eligibility and short follow-up were checked.
• Primary publication/regulatory sources checked or consulted: TrialReview.aspx?id=387349.

62. bcg-vaccine-immunotherapy — Repeat BCG vaccination

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Adult and pediatric BCG studies remain in follow-up, with estimated primary completion in 2029 and 2031. The review literature remains conflicting, not new randomized confirmation. No approved T1D indication or efficacy upgrade was established.
• Registry NCT02081326: ACTIVE_NOT_RECRUITING; updated 2026-04-13; enrollment 150 (ESTIMATED); primary completion 2029-07 (ESTIMATED); results not posted in retrieved record.
• Registry NCT05180591: ACTIVE_NOT_RECRUITING; updated 2026-06-26; enrollment 150 (ESTIMATED); primary completion 2031-03 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: j.prp.2026.156592; j.prp.2026.156592.

63. celz-201 — CELZ-201 perinatal tissue-derived cell therapy

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: CELZ-201's current randomized Phase 1/2a trial plans 18 recent-onset adults aged 18–35 and pancreatic-artery infusion. No posted results. A regenerative mechanism and safety endpoints do not prove regeneration or safety.
• Registry NCT05626712: RECRUITING; updated 2026-02-19; enrollment 18 (ESTIMATED); primary completion 2027-01-31 (ESTIMATED); results not posted in retrieved record.
• Programme/sponsor/conference source boundary: CELZ-201 for the Treatment of New Onset Type 1 Diabetes in Adults (manufacturer); CELZ-201 Clinical Trial (manufacturer).

64. dimethyl-fumarate-immunotherapy — Dimethyl fumarate for beta-cell preservation

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Both dimethyl-fumarate T1D trials recruit with C-peptide endpoints but no posted efficacy. MS approval and safety experience do not establish benefit-risk in T1D; no outcome upgrade.
• Registry NCT07258394: RECRUITING; updated 2026-03-05; enrollment 90 (ESTIMATED); primary completion 2028-12-31 (ESTIMATED); results not posted in retrieved record.
• Registry NCT07548996: RECRUITING; updated 2026-07-21; enrollment 96 (ESTIMATED); primary completion 2028-12-31 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: 204063s031lbl.pdf.

65. gnti-122-engineered-tregs — GNTI-122 engineered Tregs (POLARIS)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: GNTI-122 POLARIS has HLA restriction, n=16, a rapamycin-combination cohort and sponsor-confirmed first dosing. Treg persistence and preservation remain intended outcomes.
• Registry NCT06919354: RECRUITING; updated 2026-08-10; enrollment 16 (ESTIMATED); primary completion 2028-02 (ESTIMATED); results not posted in retrieved record.
• Programme/sponsor/conference source boundary: GentiBio — GNTI-122 for new-onset type 1 diabetes (manufacturer); GentiBio announces first participant dosed in POLARIS phase 1 clinical trial of GNTI-122 (manufacturer).

66. imc-s118ai-immtaai — IMC-S118AI (PPI × PD-1 ImmTAAI)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27T00:00:00.000Z.
• Claim check: IMC-S118AI's CT.gov not-yet-recruiting status and CTIS authorization/start-date and age-band differences remain explicit. HLA, BMI and C-peptide restrictions matter. Detailed dynamic CTIS verification remained limited; no efficacy result was located.
• Registry NCT07493122: NOT_YET_RECRUITING; updated 2026-03-25; enrollment 154 (ESTIMATED); primary completion 2030-11 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: 2025-524449-28-00.
• Programme/sponsor/conference source boundary: Immunocore reports fourth quarter and full year 2025 financial results (manufacturer).

67. leiden-toldc-immunotherapy — Leiden tolerogenic dendritic-cell therapy

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27T00:00:00.000Z.
• Claim check: LUMC's June first-recipient announcement reports no adverse effects in one person, not a safety database. The target n=10 and two-year follow-up are design features, not established durability. Detailed dynamic CTIS retrieval was limited.
• Primary publication/regulatory sources checked or consulted: 2023-508558-25-01?lang=en.

68. mixed-chimerism-islet-tolerance — Mixed haematopoietic chimerism (immune tolerance induction)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Mixed-chimerism mouse work and the MDR-101 kidney RCT address different questions. The 75% immunosuppression-free endpoint in kidney recipients is not human T1D efficacy. The closest islet/bone-marrow registry does not establish successful drug withdrawal.
• Registry NCT05973734: ENROLLING_BY_INVITATION; updated 2026-06-08; enrollment 24 (ESTIMATED); primary completion 2030-12 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: PMID 39922283; PMID 39800883; PMID 39922283; PMID 39800883.

69. opt101-cd40-peptide — OPT101 (CD40-pathway peptide)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27T00:00:00.000Z.
• Claim check: Posted OPT101 Phase 1b results show no C-peptide advantage over placebo and 18 of 24 completing. Phase 2 recruitment is a future efficacy test. Conference immunophenotyping is not proof of clinical preservation.
• Registry NCT06964087: RECRUITING; updated 2026-04-06; enrollment 72 (ESTIMATED); primary completion 2026-05-31 (ESTIMATED); results not posted in retrieved record.
• Registry NCT05428943: COMPLETED; updated 2026-08-10; enrollment 24 (ACTUAL); primary completion 2024-02-21 (ACTUAL); results posted.
• Programme/sponsor/conference source boundary: Restoring Immune Homeostasis with a Novel Peptide — Phase 1b immunophenotyping (conference).

70. pipeptoldc-tolerogenic-vaccine — PIpepTolDC tolerogenic dendritic-cell vaccine

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: PIpepTolDC Phase 1 has actual enrollment six, primary completion in 2024 and active follow-up through an estimated 2026 completion. No posted results; personalized manufacturing and safety-first design remain limits.
• Registry NCT04590872: ACTIVE_NOT_RECRUITING; updated 2026-04-22; enrollment 6 (ACTUAL); primary completion 2024-06-03 (ACTUAL); results not posted in retrieved record.

71. polyclonal-treg-therapy-t1d — Autologous polyclonal Treg therapy (T-Rex program)

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: T-Rex missed its randomized C-peptide endpoint (P=.94/.21). Phase 1 persistence does not overturn that result. July pooled immune-subtyping research is exploratory and did not test rescue of the Treg intervention.
• Registry NCT02691247: COMPLETED; updated 2021-01-08; enrollment 113 (ACTUAL); primary completion 2019-03 (ACTUAL); results posted.
• Primary publication/regulatory sources checked or consulted: scitranslmed.adn2404; scitranslmed.aad4134; s00125-026-06794-3.

72. sab-142 — SAB-142 (fully human anti-thymocyte globulin)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: SAB-142's four-treated-person Day-120 signal is sponsor-reported. Corrected rabbit-ATG “only once” assertions and press-release source classification. PRISE's estimated 1 September start has passed while the registry remains not yet recruiting. Repeat-course safety and efficacy remain unproven.
• Registry NCT07187531: RECRUITING; updated 2026-08-24; enrollment 159 (ESTIMATED); primary completion 2027-11 (ESTIMATED); results not posted in retrieved record.
• Registry NCT07670650: NOT_YET_RECRUITING; updated 2026-06-26; enrollment 108 (ESTIMATED); primary completion 2029-03-01 (ESTIMATED); results not posted in retrieved record.
• Programme/sponsor/conference source boundary: SAB BIO Presents Additional Clinical and Mechanistic Data from SAB-142 Phase 1 Trial in Adult Patients with Established Autoimmune Type 1 Diabetes at IDS 2026 (manufacturer); SAB BIO to Present Data on SAB-142 at the American Diabetes Association's 2026 Scientific Sessions and FOCIS 2026 Annual Meeting (manufacturer).

73. stem-cell-educator-therapy — Stem Cell Educator therapy

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Stem Cell Educator's early open-label report is small and does not establish causal regeneration or a durable cure. Its current registry has an unknown-status flag. No large blinded confirmation or approval was located.
• Registry NCT04011020: UNKNOWN; updated 2024-04-29; enrollment 50 (ESTIMATED); primary completion 2024-10-20 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: 1741-7015-10-3; j.autrev.2022.103058.

74. teplizumab-new-onset — Teplizumab for new-onset T1D (Tzield)

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: June label risks and original PROTECT secondary-null results remain. Added the 10 September 2026 pre-specified per-protocol analysis: 275 selected participants, TIR +6.17 percentage points with nominal P<.05; it is not a new trial or independent replication. No score upgrade. Retained the distinction between DCCT C-peptide/DKA association and demonstrated drug benefit.
• Registry NCT03875729: COMPLETED; updated 2024-04-24; enrollment 328 (ACTUAL); primary completion 2023-05-01 (ACTUAL); results posted.
• Registry NCT00385697: COMPLETED; updated 2023-12-05; enrollment 554 (ACTUAL); primary completion 2010-06 (ACTUAL); results posted.
• Registry NCT07088068: RECRUITING; updated 2026-09-14; enrollment 723 (ESTIMATED); primary completion 2028-06-06 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: s00125-026-06849-5; tzield.pdf; NEJMoa2308743; NEJMoa012864; diabetes.54.6.1763; S0140-6736%2811%2960931-8; db13-0345; fda-approves-drug-pediatric-stage-3-type-i-diabetes; dc26-0220; NEJMoa2308743; diabetes.54.6.1763; NEJMoa012864; db13-0345; S0140-6736%2811%2960931-8; dc26-0220.
• Programme/sponsor/conference source boundary: Sanofi's Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes (manufacturer); Sanofi's Teizeild approved in the EU for patients with stage 2 type 1 diabetes (manufacturer).

75. beta-cell-regeneration — Beta-cell regeneration / regrowth agents

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: DYRK1A/harmine papers concern human islet mass in mouse grafts, not demonstrated regeneration in living patients. Healthy-volunteer Phase 1 safety is not diabetes efficacy. Specificity, chronic proliferation and recurrent autoimmunity remain open.
• Registry NCT05526430: COMPLETED; updated 2025-01-16; enrollment 27 (ACTUAL); primary completion 2023-06-23 (ACTUAL); results posted.
• Primary publication/regulatory sources checked or consulted: dom.12731; nm.3820; j.cmet.2018.12.005; scitranslmed.adg3456; s41586-019-0942-8; 02698811241273772.

76. denosumab-beta-cell-preservation — Denosumab beta-cell preservation

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: Denosumab's registry requires residual C-peptide and has adult sex-specific age bands. No reported T1D benefit was located. Approval for bone disease does not establish a diabetes indication.
• Registry NCT06524960: RECRUITING; updated 2026-07-28; enrollment 45 (ESTIMATED); primary completion 2027-10-11 (ESTIMATED); results not posted in retrieved record.

77. diamyd-remygen-gaba — Remygen (oral GABA) — Diamyd's beta-cell regeneration bet

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: ReGenerate-1 found no C-peptide, HbA1c or CGM benefit, with AST elevation in nine of 35 and two withdrawals. Removed blanket safety confirmation and “benefit in no one” assertions. Pediatric lower-dose explanations remain hypotheses.
• Registry NCT03635437: COMPLETED; updated 2022-11-02; enrollment 35 (ACTUAL); primary completion 2022-09-27 (ACTUAL); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: s41598-025-95751-y; s41467-022-35544-3.

78. glp1-newonset-beta-cell — GLP-1 drugs to rescue beta cells at diagnosis

• Disposition: reviewed; no confirmed content change. Current item lastReviewed: 2026-08-27.
• Claim check: The new-onset semaglutide series has ten participants and no comparator. It does not prove beta-cell regeneration or disease modification. Adjunct obesity trials in established T1D do not establish new-onset preservation.
• Registry NCT07614412: NOT_YET_RECRUITING; updated 2026-05-29; enrollment 240 (ESTIMATED); primary completion 2028-01-31 (ESTIMATED); results not posted in retrieved record.
• Primary publication/regulatory sources checked or consulted: NEJMc2302677; 19322968241305641.

79. icovamenib-menin-inhibitor — Icovamenib (BMF-219) — oral menin inhibitor

• Disposition: corrected/updated. Current item lastReviewed: 2026-09-16.
• Claim check: COVALENT-112 is now completed (28 August registry; 37 actual participants), not terminated. Sponsor Week-12 n=5 C-peptide and Week-52 historical comparison remain uncontrolled and not peer-reviewed. Removed “largest regeneration signal” superlatives; C-peptide is not direct proof of new cell growth. Prior liver-related clinical hold remains relevant.
• Registry NCT06152042: COMPLETED; updated 2026-08-28; enrollment 37 (ACTUAL); primary completion 2025-05-20 (ACTUAL); results not posted in retrieved record.
• Programme/sponsor/conference source boundary: Biomea Fusion Announces Positive 52-Week Results from Phase 2 COVALENT-112 Trial in Type 1 Diabetes (manufacturer); Biomea Fusion Presents New Clinical and Translational Data for Icovamenib at the ADA 86th Scientific Sessions (manufacturer); Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold (manufacturer); FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials (manufacturer).

Review-date semantics — implementation recommendation

Reviewed the current methodology and changelog wording on 16 September. The methodology correctly distinguishes content review, registry check, registry update, and estimated completion. Two changelog phrases are stronger than the underlying data: “exactly how current the science ... is” and “so you always know how current a ranking's evidence is”. A date records work performed; it cannot establish completeness or currency of every supporting claim.

Recommended public wording: “See what was reviewed, what changed, and which questions remain unresolved.” Label date-only entries Reviewed, reserving Updated for records with an actual content change. Preserve the monthly material-change summary separately from the review-date list.

For each item, expose a short Review scope and limits block beside the review date, with:

• Date and concrete scope, such as “Trial status and eligibility checked against the 1 September registry update; efficacy remains based on the 2025 publication.”
• Claim-specific limitations, such as “VX-017 immune-management regimen not established in the public protocol”, “2026 letter metadata and sponsor account available; full text not independently checked”, or “Current kit ordering could not be verified”.
• Direct evidence links and source type. A conference abstract, sponsor report, abstract-only review and full publication should not look equivalent.

Use the item-level ledger as the content basis, with human-readable summaries rather than a blanket “verified” badge. Do not derive a new lastReviewed date from HTTP success, a source audit run, file modification, or unchanged registry fields alone. Old historical dates can remain when no adequate substantive review occurred. An item-level review can legitimately retain unresolved claims only if those limits are visible rather than hidden behind a recent date.

This recommendation was subsequently implemented through dated review-scope pages and linked item/trial review notes. No schema change was required for the opening evidence navigation; structured outcome and harms fields remain future model work.

Second discovery pass — new programme records

These twelve records were not part of the original 79-item census. They were checked against the sources listed individually, with uncertainty visible in the public cards and detail text. Numerical criterion scores are editorial judgments reflecting evidence and limitations, not measured treatment effects or probabilities. The candidate disposition ledger is prevent-cure-discovery.md; this is a targeted gap-finding pass, not an exhaustive census of every historical immunotherapy publication.

ladarixin-cxcr1-cxcr2

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added distinct negative-result entry. Checked the 2022 randomized publication and latest registry protocol, participant flow, primary analysis and adverse-event tables. Distinguished 289 run-in participants from 140 treatment-analysis participants, transformed C-peptide measure from natural units, and trial futility from a claim that every future ladarixin programme is discontinued.
• Primary sources checked: NCT04628481 — study record (registry); Ladarixin in new-onset type 1 diabetes: randomized placebo-controlled trial (peer-reviewed).
• Limits: The later results are sponsor-posted registry data, not a new peer-reviewed paper. Rare harms and alternative regimens are not established.

rezpegaldesleukin-treg-il2

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added a specific NKTR-358/RESET entry rather than treating the broad low-dose IL-2 item as equivalent. Checked current trial age-staging, target enrolment, dosing, status and dates; developer page supports proposed mechanism only.
• Primary sources checked: NCT07142252 — study record (registry); Nektar pipeline: rezpegaldesleukin in type 1 diabetes (manufacturer).
• Limits: No posted T1D outcomes. Dermatology efficacy and safety are not transferred to diabetes. Current site and individual age-cohort openings require confirmation.

ixekizumab-il17a

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added I-DIT entry. Checked current registry, planned rather than actual sample, eligibility and lack of posted outcomes; January 2026 US Taltz label checked for indications and material warnings.
• Primary sources checked: NCT04589325 — study record (registry); Taltz (ixekizumab) US prescribing information, revised January 2026 (regulatory).
• Limits: No demonstrated T1D effect or specific T1D harms rates. Other-country labels and stock were not surveyed.

dfmo-beta-cell-protection

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added DFMO/TADPOL entry. Checked 2023 publication including small dose groups, primary safety outcome, allergic withdrawal and secondary C-peptide signal; current Phase 2 status and actual 74 enrolment from registry. The early publication reports 31 drug+10 placebo; an older registry description retains 2:1 planned allocation.
• Primary sources checked: Inhibition of polyamine biosynthesis preserves beta-cell function in type 1 diabetes (peer-reviewed); NCT05594563 — study record (registry); NCT02384889 — study record (registry).
• Limits: The Phase 2 trial has no results. Regeneration category is explicitly explained as a grouping: no demonstrated human beta-cell regrowth. No extrapolation from oncology dosing or efficacy.

sorafenib-beta-cell-preservation

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added a narrow repurposing entry. Checked trial status, target 10, adult eligibility, insulin continuation and dates; current Bayer-hosted US label supports known drug warnings and cancer indications.
• Primary sources checked: NCT06227221 — study record (registry); Nexavar (sorafenib) US prescribing information, revised August 2023 (regulatory).
• Limits: Registry still not yet recruiting despite passed estimated start. No T1D benefit or safety outcomes. Selective immune mechanism is not asserted; category is editorial grouping.

anti-il21-liraglutide

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added a historical discontinued programme. Checked the randomized Phase 2 abstract, registry and Novo Q3 2020 discontinuation announcement, plus FDA orphan status. Uses 308 randomized, not an asserted 308-person treated analysis denominator. Benefit at 54 weeks and deterioration off treatment remain distinct.
• Primary sources checked: Anti-IL-21 antibody and liraglutide in recent-onset T1D: randomized Phase 2 trial (peer-reviewed); NCT02443155 — study record (registry); Novo Nordisk Q3 2020 financial report: combination development discontinued (manufacturer); FDA orphan designation record for NNC0114-0006 plus liraglutide (regulatory).
• Limits: Paper abstract supports numerical claims; full patient-level data were not reanalyzed. Regulatory-path discontinuation is not relabeled as efficacy failure. No active programme or current treatment access claimed.

cnp-103-tolerogenic-nanoparticles

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added programme item and corrected associated trial. Checked September 11 registry and publisher-deposited ADA abstract through Crossref: six-adult cohort, early dosing, no serious events reported, no C-peptide efficacy result. Company pipeline and current recruitment page distinguish mechanism/designation from clinical evidence.
• Primary sources checked: NCT06783309 — study record (registry); ADA 2026 abstract 2419-P: CNP-103 first-in-human study (conference); COUR pipeline — CNP-103 intended immune-tolerance mechanism (manufacturer); COUR CNP-103 clinical trial information (manufacturer).
• Limits: Conference report is not full trial outcomes or proof of overall safety. Sponsor page gives conflicting site counts and participation duration; no exact counts repeated. Four recombinant proteins are described but precise payload coverage is not independently validated.

cd6-car-treg

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added distinct autologous engineered Treg programme. Read current registry intervention, sequential safety design, eligibility,15-year follow-up plan and status; City of Hope independently lists it under Coming Soon.
• Primary sources checked: NCT07395050 — study record (registry); City of Hope diabetes clinical trials — CD6-CAR Tregs coming soon (news).
• Limits: Estimated September dates passed; no start/completion inferred. No T1D outcomes. Results for allogeneic CD6-CAR Tregs in graft-versus-host disease do not establish this autologous T1D programme.

cd7-car-t-rd13-02

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added named RD13-02 donor-derived CD7-CAR-T programme, with current registry dose escalation, safety stopping rules, target 9 and stage 2/3 eligibility.
• Primary sources checked: NCT07528105 — study record (registry).
• Limits: No posted outcomes. Stage 2 eligibility does not establish preventive benefit, and a donor-cell protocol is not an approved treatment. No local recruitment confirmation beyond registry.

carc-101c-engineered-red-cells

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added named CARC-101C programme. Registry arms explicitly identify engineered red blood cells; no inference from CARC name to CAR-T. Checked single-dose design, target 12 and narrow recent-onset eligibility.
• Primary sources checked: NCT06546436 — study record (registry).
• Limits: Latest registry is August 2024, not yet recruiting despite old estimated primary completion. Current activity and precise payload are unconfirmed; no outcome or availability implied.

cnk-ut009-immune-cell-therapy

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added narrowly described CNK-UT009 cell programme from registry. Retained phase not applicable rather than invented Phase 1; checked target 12, residual C-peptide eligibility, safety/dose-limit objectives and old update date.
• Primary sources checked: NCT07051564 — study record (registry).
• Limits: Precise cell manufacturing, target, pretreatment and product-specific harms are not adequately characterized in the verified source. Current recruitment unconfirmed; no T1D outcomes posted. No additional programme inferred from dual registration.

ain-shams-adipose-insulin-cells

• Disposition: new record; substantive review 16 September 2026.
• Scope and findings: Added specific Ain Shams university protocol. Checked autologous adipose collection, differentiation intent, portal versus peripheral delivery, target 20 adolescents and sponsor-entered Phase 2/3. Visible text distinguishes registered phase from demonstrated pivotal maturity.
• Primary sources checked: NCT06951074 — study record (registry).
• Limits: April 2025 record remains recruiting despite passed estimated completion dates. No reported insulin independence, engraftment durability, safety dataset or validated immune-protection strategy. Not linked to commercial clinics or sold as a treatment.