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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 report vascularized, non-fibrotic devices with viable human islets, but no insulin-independence results are posted.

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: non-fibrotic engraftment, robust vascularization, and viable encapsulated human islets after 4 months. Treat as company-reported early safety/explant evidence, not clinical efficacy or insulin-independence proof.

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 The primary endpoint is safety through Day 134.1

Early evidence

Encellin reported interim explant results in January 2026, saying devices removed after 4 months showed non-fibrotic engraftment, robust vascularization, and viable human islets.2 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.

References

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

  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 ↩