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.

Encellin

Status and phase: Begins enrollment in 5 months; Phase 1

Conditions: Type 1 Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07680673

2-IND-2026-1973-I-X (Other Grant/Funding Number)

ENCRT-103-hPI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

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

Experimental group

Description:

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:

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 group

Description:

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

Treatment:

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