🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07126873
Recruiting Phase 1/2

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

NCT07126873 · tracked via the Priya Life Science China tracker
Sponsor
EndoCell Therapeutics, Inc.
Phase
Phase 1/2
Started
2025-08-11
Last updated
2025-08-22

Condition(s) studied

Diabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia

Investigational drug(s) / intervention(s)

Allogeneic Human E-islet (E-islet 01)

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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Clinical history of Type 1 Diabetes with \> 5 years of duration * 2-hour C-peptide level \<0.3 ng/mL after a mixed meal stimulation test * Under continuous insulin therapy, Participants have at least one of the following conditions: 1. At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment; 2. Unaware hypoglycemia evaluated using the Clarke scoring system * Willing and able to conduct self-blood glucose monitoring as required, with good compliance * Voluntarily participate and sign the informed consent form Exclusion Criteria: * Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab). * History of malignancy within the past 5 years or undergoing antitumor treatment * Participation in other clinical trials in the 3 months or islet cell transplant, organ transplant, or cell therapy in the 12 months prior to enrollment * Other situations judged by the investigator as unsuitable for participation in the trial

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Changzheng Hospital Shanghai Shanghai Municipality Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07126873 on ClinicalTrials.gov ↗ ← All trials in China