ENC-201-CED: Encellin encapsulated donor islets
What this study tests
Phase 1 safety study of encapsulated donor islets in Canada. July sponsor reporting describes seven participants and non-fibrotic engraftment; insulin independence has not been demonstrated.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-03-11.
Most recent recorded citation date: 2026-07-08. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults aged 18-70 with T1D who satisfy site eligibility for standard-of-care islet infusion. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No registry-posted results. The July 2026 ISSCR-hosted sponsor release reports enrollment complete at seven, versus the registry estimate of 10. Interim explant observations do not establish clinical efficacy. The estimated primary-completion date of 31 July 2026 has passed without a registry readout.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: Canada. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Primary endpoints
- Safety from Day 1 through Day 134
The full picture
What is being tested
ENC-201-CED is Encellin's Encapsulated Cell Replacement Therapy device loaded with human primary islets.1 The registry describes the product as macro-encapsulated human primary islets placed in a subcutaneous space, with device feasibility and safety as the purpose.1
Design
The study is a single-group Phase 1 trial at University Health Network in Toronto and McGill University Health Centre in Montreal.1 It plans 10 adults aged 18-70 who already meet site eligibility for standard-of-care islet infusion.1 It started in May 2024, is now active but no longer recruiting, and is sponsored by Encellin with resCON Research as a collaborator.1 The primary endpoint is safety through Day 134.1
Two of the secondary endpoints go straight at the field's core problem. "Containment" counts how many islet equivalents remain inside the device once it is explanted after Day 120 — in other words, are the cells still there. "Engraftment" is histopathology measuring the degree of fibrosis, in millimetres, from the surface of the device.1 Fibrosis — the scar tissue the body lays down around a foreign object, which can starve encapsulated cells of oxygen and nutrients — is the failure mode that has sunk earlier encapsulation attempts, and this trial is explicitly instrumented to measure it.
Early evidence
January interim reporting covered five participants; viable islets were identified in the initial evaluated explant, rather than confirmed in all five.2 The July update described non-fibrotic engraftment across seven participants, with vascularization and islets identified in multiple participants. Full analysis was ongoing.4 These sponsor observations do not demonstrate insulin independence or durable glucose control.
Current status
The registry remains active, not recruiting, with estimated enrollment of 10; the July release says enrollment finished at seven.14 The registry was last updated on 11 March 2026. Its estimated primary completion of 31 July has passed, and estimated study completion remains 30 October 2026. No results are posted; an estimated completion date is not a result.1
Sources
- [1]
- [2]Encellin announces interim clinical results showing first-in-human non-fibrotic engraftment and viable encapsulated human islets · Manufacturer · 2026-01-13
Encellin. Encellin Announces Interim Clinical Results Showing First-in-Human Non-Fibrotic Engraftment and Viable Encapsulated Human Islets in Subjects with Type 1 Diabetes.
- [3]Cell therapy trial: Encellin's device delivers promising early results · Open-source community · 2026-01-06 — Reports that the January 2026 interim findings covered the first five subjects.
- [4]Encellin Phase 1 progress at ISSCR 2026 · Manufacturer · 2026-07-08 — Sponsor release hosted by ISSCR; open-label safety study, not designed to measure efficacy.
Encellin / ISSCR. Phase 1 clinical progress. 8 July 2026.