16 September 2026 editorial review · Trial
VC-01: ViaCyte first-gen encapsulated stem-cell islets: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Primary-agent trial review — 16 September 2026
Assessment: Summary, current status, primary endpoint and key eligibility compared with the current registry. No additional discrepancy confirmed in that comparison. Historical outcome details beyond the primary sources explicitly discussed in the specialist ledgers were not all independently reverified.
Registry: NCT02239354; TERMINATED; updated 2022-03-24; enrollment 19 (ACTUAL); results posted.
Endpoint comparison: Number of Adverse Events Reported During the Study. (Thru the Month 24 Visit); Change in C-peptide (Baseline to the Month 6 Visit).
Sources for this record: NCT02239354: study record (registry); CIRM: VC-01 clinical trial Year 4 progress report (community); ViaCyte: two-year STEP ONE data presented at ADA 2018 (manufacturer).
Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.
Selected cell-therapy and adjunct trial review — 16 September 2026
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.