Safety of ENC-201-CED ENCRT

Phase 1

Recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Combination Product: ENC-201-CED hPI

• Registration Number: NCT06408311
• Lead Sponsor: Encellin

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of ENC-201-CED in a subcutaneous space in patients with Type I diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Candidates must satisfy site's eligibility for standard of care islet infusion.

Exclusion Criteria

• Candidates are excluded based on the site's criteria for standard of care islet infusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ENC-201-CED hPI	ENC-201-CED hPI	-

Primary Outcome Measures

Name	Time	Method
Safety	Day 1 through Day 134	Rate of device-related Adverse Events (AE)

Secondary Outcome Measures

Name	Time	Method
Containment	post Day 120	Assessment of number of islet equivalents (IEQ) in explants
Engraftment	post Day120	Histopathology to examine degree of fibrosis (mm) from surface of CED.

Trial Locations

Locations (2)

UHN; 🇨🇦 Toronto, Ontario, Canada

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada