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NCT Number: NCT06408311

Safety of ENC-201-CED ENCRT

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UHN, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ENC-201-CED hPI

Combination Product

macro-encapsulated human primary islets

Primary outcomes

  1. Safety

    Time frame: Day 1 through Day 134

    Rate of device-related Adverse Events (AE)

Secondary outcomes

  1. Containment

    Time frame: post Day 120

    Assessment of number of islet equivalents (IEQ) in explants

  2. Engraftment

    Time frame: post Day120

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

Sponsors and collaborators

Lead sponsor

Encellin

Industry

Collaborators

  • resCON Research

Registry information

Official study title

A Safety and Tolerability Study of ENC=201-CED in Participants With Type 1 Diabetes Receiving Islet Infusion

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 10, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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