ENCRT-103-hPI: Encellin's next-generation encapsulation device
What this study tests
A planned first-in-human Phase 1 study of ENC-103, Encellin's follow-on encapsulation device - a soft, roughly quarter-sized pouch loaded with donor human islets and implanted in the upper arm or abdomen, then removed after about four months. It runs two cohorts: people who are also receiving a standard portal-vein islet infusion, and people who are not. Not yet recruiting; the registry lists a January 2027 start at three Canadian sites, with 10 participants planned.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-08-20.
Source dates appear in the references where available; this record has no dated citation metadata.
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 18-75 with type 1 diabetes. Cohort A meets its institution's criteria for standard-of-care islet infusion; Cohort B does not receive one. The registry gives no further detail, deferring to each site's standard of care. 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
- None. The study has not started. The registry lists a start date of 6 January 2027, primary completion of 6 July 2028 and study completion in January 2029. Those are plans, not promises - registry dates slip routinely.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.
Primary endpoints
- Rate of device-related adverse events over roughly 4.5 months, together with local tissue response, vascular integration and immune-cell exclusion at explant
The full picture
What is being tested
ENC-103 is Encellin's next-generation encapsulation device: a soft implant, roughly the size of a quarter, loaded with primary human islets and placed under the skin of the upper arm or abdomen.1 The idea behind every encapsulation device is the same — build a barrier fine enough to keep immune cells away from transplanted islets, but open enough to let glucose in and insulin out, so the cells can do their job without the recipient needing lifelong immunosuppression.
This is a different device from the ENC-201 already in the clinic (NCT06408311). ENC-103 is a second-generation product with its own first-in-human study, and it is not yet recruiting.
Design
The registry describes a non-randomized, dual-arm, three-centre Phase 1 study planned for 10 adults aged 18–75 with type 1 diabetes; the locations currently posted are Vancouver General Hospital and University Health Network in Toronto.1 The device is implanted, left in place for about four months, then explanted and examined.1
The primary endpoint is the rate of device-related adverse events over roughly 4.5 months. Alongside safety, the study assesses local tissue response, vascular integration, and immune-cell exclusion — that last one being the whole point of the device, and something you can only really check by taking the implant out and looking at it.1
The part that matters: two cohorts
The trial splits into two groups.1
- Cohort A enrols people who are also receiving a standard portal-vein islet infusion — the conventional islet transplant, which comes with conventional immunosuppression.
- Cohort B enrols people who are not receiving that infusion, and instead uses what the registry calls a special access drug regimen.
Cohort B is the more informative arm. In Cohort A, any islet function you observe could be coming from the infused islets in the liver rather than from the cells inside the device, and the immunosuppression the patient is already on muddies the question of whether the device is protecting anything. Cohort B removes that confound and puts the device closer to being tested on its own terms. It is still only 10 planned participants across both cohorts, and the primary endpoint is safety — this is not a study designed to show that anybody's blood sugar improved.
What to watch
Nothing has happened yet. The study is listed as not yet recruiting with an estimated start of 6 January 2027 and estimated primary completion of 6 July 2028.1 Realistically, the first useful signal would be explant data — how much fibrosis formed around the device, whether the islets inside were still alive, whether immune cells got in — the same kind of explant evidence Encellin has described in company updates from the ENC-201 study.
Two honest caveats. First, this is a registry entry for a trial the registry lists as not yet recruiting — no enrollment is reported — with an explicitly estimated start date, and such dates routinely slip. Second, even a clean result here does not solve the supply problem: the device is loaded with donor islets, and donor islets remain scarce. Encapsulation and cell supply are two separate walls between here and a cure, and this study is aimed at the first one.
Sources
- [1]Evaluation of ENCRT-103-hPI, an Immune-protected Combination Product Containing Primary Human Islets in Adults With Type 1 Diabetes · Trial registry
Encellin. Evaluation of ENCRT-103-hPI, an Immune-protected Combination Product Containing Primary Human Islets in Adults With Type 1 Diabetes. ClinicalTrials.gov NCT07680673.