16 September 2026 editorial review · Trial
VX-264: encapsulated stem-cell islets without immunosuppression: 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: Separated discontinued product from active follow-up of 7 participants; September 10 registry date and March 2027 estimate. Removed unsupported mechanistic explanation for failure and broad safety certainty. Company outcome report is not a detailed participant-level publication.
Registry: NCT05791201; ACTIVE_NOT_RECRUITING; updated 2026-09-10; enrollment 7 (ACTUAL); results not posted.
Endpoint comparison: Part A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Day 1 up to 24 months); Part B: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT) (From Baseline and at Day 90).
Sources for this record: Vertex Pharmaceuticals. Vertex Doses First Patient in Phase 1/2 Trial of VX-264 in Type 1 Diabetes (coverage). CGTLive (2023) (news); Masson G. Vertex drops cell-device diabetes combo over poor phase 1 results. Fierce Biotech (2025) (news); ClinicalTrials.gov. A Study to Evaluate the Safety, Tolerability, and Efficacy of VX-264 in Subjects With Type 1 Diabetes Mellitus (NCT05791201). U.S. National Library of Medicine (accessed 2026) (registry); Vertex Pharmaceuticals. Vertex Announces Program Updates for Type 1 Diabetes Portfolio. Vertex Pharmaceuticals (2025) (manufacturer); Advances in Cell Replacement Therapies for Diabetes. (peer-reviewed).
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.