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 range18 Years – 75 Years

SexALL

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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

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