16 September 2026 editorial review · Trial
ENC-201-CED: Encellin encapsulated donor 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 →Baseline trial evidence review: A–H
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06408311. Registered endpoint checked: Safety (Day 1 through Day 134). Eligibility check: Registry age 18 Years to 70 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
Primary-agent trial review — 16 September 2026
Assessment: Reconciled the July sponsor update with the older registry: seven enrolled versus ten estimated. Interim explant findings remain distinct from clinical efficacy. January viable-islet findings were limited to the initial evaluated explant. Passed estimated completion is not a readout.
Sources: Current registry; July sponsor release hosted by ISSCR.
Limits: Open-label safety study; no posted registry results or demonstrated insulin independence.