NCT07680673

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
24mo left

Started Jan 2027

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

January 6, 2027

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

June 24, 2026

Last Update Submit

July 7, 2026

Conditions

Type 1 Diabetes

Keywords

islets, islet cell transplantation islet transplantation, Diabetes Mellitus, Diabetes Mellitus Type 1, Glucose Metabolism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assessment of IEQ (islet equivalent) population present in explants

    4 months

Other Outcomes (1)

  • Exploratory functional outcomes

    4 months

Study Arms (2)

Cohort A: ENCRT-103-hPI with standard of care

EXPERIMENTAL

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.

Cohort B: ENCRT-103-hPI only

EXPERIMENTAL

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.

Interventions

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

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.

Also known as: ENCRT, ENCRT-103, ENCRT-103-hPI, ENC-103, ENC-103-CED
Cohort A: ENCRT-103-hPI with standard of careCohort B: ENCRT-103-hPI only

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

UHN

Toronto, Ontario, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2026

First Posted

July 2, 2026

Study Start (Estimated)

January 6, 2027

Primary Completion (Estimated)

July 6, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

July 8, 2026

Record last verified: 2026-07

Locations

CA(3)