The Purpose of the Study is to Evaluate the Safety and Performance of ENCRT-103-hPI in Patients With Type I Diabetes. ENCRT-103-hPI is an Implantable Product Shielding Primary Islets From the Immune System.

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.

Detailed Description

This study is a dual-arm, three-centre, non-randomized, FIH trial that will evaluate the safety of the ENCRT-103-hPI in patients with T1D. Study subjects may be receiving standard of care islet infusion (cohort A), or not (cohort B). Cohort B will receive a special access drug regimen compared to cohort A's standard of care immune management.

Both cohorts will experience equivalent processes: donor matching, comparable ENCRT-103-hPI dosages, implant into the upper arm or abdomen, explant at 4 mo and post surgical followup.

The primary objective is to evaluate the safety, tolerability, and local tissue response of fully immune-protected ENCRT devices containing primary human islets in adults with Type 1 Diabetes. Included in assessments are vascular integration and immune cell exclusion.

The secondary objectives are to evaluate of the activity, function, and survival of the donor islets from the retrieved ENCRT-103-hPI.

The exploratory objectives include measures of circulating and stimulated C-peptide, HbA1c, insulin use doses, and when available, CGM trends.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital
      • Principal Investigator: Michael Bleszynski, MD
  • Ontario
    • Toronto, Ontario, Canada
      • UHN
      • Principal Investigator: Trevor Reichman, MD
      • Contact: Site coordinator, DDM; Phone Number: 416-340-4800; Email: honey.lad@uhn.ca
  • Quebec
    • Montreal, Quebec, Canada
      • McGill University Health Centre
      • Contact: Site coordinator; Phone Number: 514-934-1934; Email: kerry.mckenna@muhc.mcgill.ca
      • Principal Investigator: Rohan Kumar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: ENCRT-103-hPI with standard of care; 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.	Device: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.; The ENC-103-CED is a unique device on the landscape. It is a soft, device made of non-fibrosis inducing material and design features. ENCRT-103-hPI that will be implanted consists of this device loaded with primary islets. Both cohorts A and B will receive the intervention of an ENCRT-103-hPI implant.; Other Names: ENCRT; ENCRT-103; ENCRT-103-hPI; ENC-103; ENC-103-CED
Experimental: Cohort B: ENCRT-103-hPI only; Patients receive only an ENCRT implant (the intervention) and a special access drug regimen for immune management.	Device: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.; The ENC-103-CED is a unique device on the landscape. It is a soft, device made of non-fibrosis inducing material and design features. ENCRT-103-hPI that will be implanted consists of this device loaded with primary islets. Both cohorts A and B will receive the intervention of an ENCRT-103-hPI implant.; Other Names: ENCRT; ENCRT-103; ENCRT-103-hPI; ENC-103; ENC-103-CED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of device-related adverse events (AEs)	The primary objective is to evaluate the safety, tolerability, and local tissue response of fully immune-protected ENCRT devices containing primary human islets in adults with Type 1 Diabetes. Included in assessments are vascular integration and immune cell exclusion.	4.5-5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of IEQ (islet equivalent) population present in explants	The secondary objectives are to evaluate of the activity, function, and survival of the donor islets from the retrieved ENCRT-103-hPI through marker expression in histological sections.	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory functional outcomes	Characterize potential functional engraftment via device removal and fixation for histopathological analysis (post-explant).	4 months

Collaborators and Investigators

• Sponsor: Encellin

Study record dates

Study Major Dates

• Study Start (Estimated): January 6, 2027
• Primary Completion (Estimated): July 6, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: islets, islet cell transplantation islet transplantation, Diabetes Mellitus, Diabetes Mellitus Type 1, Glucose Metabolism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: ENCRT-103-hPI; 2-IND-2026-1973-I-X (Other Grant/Funding Number: Breakthrough T1D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Participating institutions may restrict.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No