Safety of ENC-201-CED ENCRT

NCT ID: NCT06408311

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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ENC-201-CED hPI

Group Type EXPERIMENTAL

ENC-201-CED hPI

Intervention Type COMBINATION_PRODUCT

macro-encapsulated human primary islets

Interventions

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ENC-201-CED hPI

macro-encapsulated human primary islets

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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resCON Research

UNKNOWN

Sponsor Role collaborator

Encellin

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grace Wei, PhD

Role: STUDY_DIRECTOR

Encellin

Locations

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UHN

Toronto, Ontario, Canada

Site Status RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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ENC Trial Info

Role: CONTACT

6504340987

resCON Research

Role: CONTACT

Facility Contacts

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Trial Coordinator, BSc

Role: primary

416-340-4800 ext. x7393

Lin Jawhar

Role: primary

Other Identifiers

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ENC201PD

Identifier Type: -

Identifier Source: org_study_id

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