Skip to content
type1.science
Phase 1Active, not recruitingNCT06408311

ENC-201-CED: Encellin encapsulated donor islets

First-in-human Phase 1 safety and tolerability study of Encellin's subcutaneous ENCRT thin-film encapsulation device loaded with human primary donor islets. The trial is active, not recruiting, in Canada with 10 planned adults; company interim explant data from the first five subjects report vascularized, non-fibrotic devices with viable human islets, but no insulin-independence results are posted. Registry primary completion is set for 31 July 2026.

Primary endpoints

  • Safety from Day 1 through Day 134

Results so far

No registry-posted results. Encellin reported interim human explant findings in January 2026 from the first five subjects: non-fibrotic engraftment, robust vascularization, and viable encapsulated human islets after 4 months of implantation. Treat as company-reported early safety/explant evidence, not clinical efficacy or insulin-independence proof. The registry lists primary completion as 31 July 2026 and study completion as 30 October 2026, so a fuller readout may come in H2 2026 - registry dates slip often and should not be read as a promise.

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

Encellin reported interim explant results in January 2026 covering the first five subjects, saying devices removed after 4 months showed non-fibrotic engraftment, robust vascularization, and viable human islets.23 That is an important early signal for the encapsulation/fibrosis problem, but it is not proof of meaningful insulin production, C-peptide benefit, or insulin independence.

What to watch

The registry lists primary completion as 31 July 2026 and overall study completion as 30 October 2026, and no results are posted yet.1 That puts a fuller readout — including the explant fibrosis and islet-survival measurements above — plausibly in the second half of 2026. Treat those dates as a plan, not a promise: registry completion dates slip routinely, especially at small companies.

References

  1. Encellin, Inc. Safety of ENC-201-CED ENCRT. ClinicalTrials.gov NCT06408311. https://clinicaltrials.gov/study/NCT06408311 ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8

  2. Encellin. Encellin Announces Interim Clinical Results Showing First-in-Human Non-Fibrotic Engraftment and Viable Encapsulated Human Islets in Subjects with Type 1 Diabetes. https://www.encellin.com/news/encellincloses99m-bjbbm-2cg4k ↩

  3. Breakthrough T1D Canada. Cell therapy trial: Encellin's device delivers promising early results. 6 January 2026. https://breakthrought1d.ca/cell-therapy-trial-encellins-device-delivers-promising-early-results/ ↩