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Not yet taking people in CanadaPhase 1

Testing an implanted device holding donor islet cells in adults with type 1 diabetes

Tests an implanted device holding donor islet cells in adults with type 1 diabetes.

Key facts

Who runs it
Encellin
Where
Toronto and Vancouver, CanadaSee the 2 sites
Trial code
Registry title
ENCRT-103-hPI: Evaluation of an Immune-protected ENCRT-103-hPI Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.
Status
Not yet recruiting
Phase
Phase 1
People taking part
10 people, planned
Starts
6 Jan 2027
Expected to end
Jan 2029
Type of study
Interventional, 2 groups
Treatments tested
  • ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.
Record updated
20 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 with type 1 diabetes. Some are on an islet infusion wait list and some are not.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Type 1 diabetes. No stage or severity is given in the record.

Main reasons for not taking part

  • Exclusion rules follow the institution's standard of care (cohort A) or the care team's guidelines (cohort B). The record gives no details.

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B)

Who cannot take part

  • - follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Canada

  • UHNToronto, CanadaContact: Site coordinator, DDMNo longer taking part
  • Vancouver General HospitalVancouver, CanadaContact: Michael Bleszynski, MD (principal investigator)No longer taking part

About the trial

What the trial wants to find out

This study will evaluate the safety and performance of ENCRT-103-hPI, which is a cargo of primary islets inside Encellin's ENC-103-CED. The 103 offers a soft pillow-like encasing to contain and protect the cells from the immune system. The product is implanted in the upper arm or abdomen and is approximately the size of a quarter. Eligibility is open to both patients on a standard of care islet infusion wait list, as well as those who are not. Participation in this trial does not preclude future Encellin trial participation. The study duration is 4.5months and requires keeping the implant for 4 months, as well as adhering to a standard of care schedule of follow ups during the implant period.

The 2 groups in the trial

  • Cohort A: ENCRT-103-hPI with standard of careTreatment being tested

    Patients receive standard of care islet infusion and the intervention of an ENCRT implant on the same day. Cohort A also receives standard of care drug regimen for immune management.

    Treatment: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.

  • Cohort B: ENCRT-103-hPI onlyTreatment being tested

    Patients receive only an ENCRT implant (the intervention) and a drug for engraftment and immune management.

    Treatment: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of ENCRT-103-hPI, an Immune-protected Combination Product Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.
Plain-language title
Testing an implanted device holding donor islet cells in adults with type 1 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07680673, who can take part
Record updated
20 August 2026