RecruitingPhase 1/2

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

China21 participantsStarted 2025-08-11

Plain-language 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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;
. Unaware hypoglycemia evaluated using the Clarke scoring system

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From E-islet 01 infusion to end of study (up to 5 years)

Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycated Haemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in Glycosylated hemoglobin(HbA1c) From Baseline

Timeframe: At 1 year after E-islet 01 infusion

Trial details

NCT IDNCT07126873

SponsorEndoCell Therapeutics, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

yanyan ma

+8618621591910 mayanyan@endocell.cn

View on ClinicalTrials.gov More Diabetes Mellitus, Type 1 trials