Safety of ENC-201-CED ENCRT

Phase 1Active Not RecruitingNCT06408311

Encellin10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

ENC-201-CED hPICOMBINATION_PRODUCT

macro-encapsulated human primary islets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (2)

UHN

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Safety

Rate of device-related Adverse Events (AE)

Time frame: Day 1 through Day 134

Secondary Outcomes

Containment

Assessment of number of islet equivalents (IEQ) in explants

Time frame: post Day 120

Engraftment

Histopathology to examine degree of fibrosis (mm) from surface of CED.

Time frame: post Day120

Data from ClinicalTrials.gov

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