Selected cell-therapy and adjunct trial review — 16 September 2026

Scope: eight parent-assigned records. Reviewed substantive summary, intervention, eligibility, outcomes and body against the sources below. Preserved direct item relationships and registry-check fields. This is an evidence/content audit, not clinical validation. Last-reviewed dates apply to these reviewed records only.

vc-01-viacyte-encapsulated

Outcome and correction: Retained insufficient functional engraftment and foreign-body response; removed unsupported certainty that most cells died from measured oxygen deprivation, universal field-impact claims, and broad safety/proof claims.

Primary sources checked: Registry NCT02239354; CIRM investigator/funder progress; ViaCyte ADA 2018 report.

Limits: Early sponsor/funder observations; no controlled efficacy inference. Oxygen limitation is biologically plausible but more specific causal wording exceeded the directly reviewed evidence.

vctx210-crispr-encapsulated

Outcome and correction: Removed proof-of-concept success inference, specific edit/device claims relying on secondary coverage, and mistaken implication that CTX211 became a Vertex program. Seven enrolled/completed study retained; missing outcomes made explicit.

Primary sources checked: Registry NCT05210530; CRISPR/ViaCyte first dosing announcement.

Limits: No registry results or peer-reviewed clinical outcome paper identified; study completion is not demonstrated safety/efficacy.

vctx211-crispr-hypoimmune

Outcome and correction: Corrected five enrolled versus assumed five dosed; reconciled no posted results with company-reported 12-month C-peptide; removed first-ever and validated-success claims.

Primary sources checked: Registry NCT05565248; CRISPR January 12, 2026 SEC-filed update.

Limits: Unquantified sponsor C-peptide statement, no patient-level or controlled outcome dataset.

Additional 16 September correction: inspected 3 August 2026 corporate update, slide 41. It adds company claims of no serious adverse events or adverse events of special interest, 12-month C-peptide and histologic insulin-cell survival despite device fibrosis and immune-cell infiltration. Summary, results and narrative now include this sponsor-only context; it supersedes the earlier description of a single brief C-peptide statement. The formal registry status remains terminated despite the slide describing Phase 1 as completed. Five enrolled is not assumed to mean five dosed or five contributing to each observation. Linked to the existing CTX213 programme item as predecessor context, with no successor human-efficacy inference. Full clinical results and participant-level safety interpretation remain limited.

verapamil-newonset

Outcome and correction: Identified this as European Ver-A-T1D, not earlier US studies. Primary endpoint not met; per-protocol result cannot rescue it. Conference provenance explicit; investigator explanation attributed; broad safety claim removed.

Primary sources checked: Protocol; EASD September 2025 primary society release; Registry NCT04545151.

Limits: Release says no full paper available at presentation; full outcome publication not identified in this review. Exact P=.06/.034 removed because directly accessible society release describes significance without these values. Direct EurekAlert fetch returned 403, but web search returned the society release text.

tirtle1-tirzepatide-t1d

Outcome and correction: Existing numerical outcomes and safety counts retained after primary full-text check. Added important exclusions (recent DKA/severe hypoglycemia, gastroparesis, pancreatitis, retinopathy and pregnancy).

Primary sources checked: Primary full text, PMC12719702; DOI.

Limits: Twenty-four randomized, 22 completed, 12 weeks; inadequate to exclude uncommon harms. ANZCTR eligibility corroborated by primary paper rather than a fresh registry extraction.

t1ger-golimumab

Outcome and correction: Removed old-map editorial history; retained 84 participants, C-peptide .64 vs .43, P<.001, lower insulin and similar HbA1c. Added autoantibody/C-peptide criteria and relevant hypoglycemia adverse-event/anti-drug antibody findings.

Primary sources checked: NEJM primary abstract; Registry NCT02846545.

Limits: Abstract-level outcome review; no new long-term efficacy or safety claim. Distinguishes investigator-recorded hypoglycemia adverse events from overall mean event counts.

up421-hypoimmune-islets

Outcome and correction: Corrected estimated enrollment two versus one published recipient. Removed ranking superlatives and unsupported 2–7%/15–50-fold dose extrapolation. Added primary 2025 report, 2026 follow-up citation, and exact sponsor update. Added restrictive eligibility.

Primary sources checked: NEJM 2025; NEJM 2026 letter metadata; Sana July 13, 2026 follow-up; Registry NCT06239636.

Limits: 2025 abstract reviewed; 2026 letter metadata verified but full letter not independently retrieved. Follow-up details attributed to Sana. One low-dose recipient cannot establish insulin independence or uncommon harms.

tegoprubart-islet-transplant

Outcome and correction: Retained 12/12 sponsor-reported insulin independence; distinguished initial cohort from registry target 70. Removed unproved comparative safety/superiority and speculative policy claims. Added omitted immunosuppression-related adverse events managed through mycophenolic-acid dose reduction. Updated stale citation status and detailed eligibility.

Primary sources checked: Registry NCT06305286; Eledon June 8, 2026 primary company report.

Limits: Single-arm interim company/conference report, median follow-up eight months. Absence of selected toxicity signals cannot establish safer therapy. Continuing immunosuppression explicit.

Validation: npm run validate passed after correcting the CIRM citation source to the supported community enum (primary funder report described in its note).