RecruitingPhase 1Phase 2NCT07126873

A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes

A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of E-islet 01 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia


Sponsor

EndoCell Therapeutics, Inc.

Enrollment

21 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the safety, tolerability and efficacy of E-islet 01 in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy called E-islet 01 — a treatment designed to help the body produce insulin again — in people with Type 1 diabetes who struggle with severe low blood sugar episodes. **You may be eligible if...** - You have had Type 1 diabetes for more than 5 years - Your body produces very little or no insulin on its own (confirmed by a special test) - You are on continuous insulin therapy - You have had at least one severe low blood sugar episode in the past year, OR you have hypoglycemia unawareness (you don't feel warning signs when your blood sugar drops) - You are willing and able to check your blood sugar regularly **You may NOT be eligible if...** - You have active infections including tuberculosis, active hepatitis, or HIV - You have had cancer in the past 5 years or are currently on cancer treatment - You have participated in another clinical trial in the past 3 months - You have had an islet cell, organ, or cell therapy transplant in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAllogeneic Human E-islet (E-islet 01)

Allogeneic Human E-islet (E-islet 01), Infused into the hepatic portal vein


Locations(1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

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NCT07126873


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