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

NCT07126873 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-08-22

No results posted yet for this 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

Conditions

  • Diabetes Mellitus, Type 1
  • Impaired Hypoglycemic Awareness
  • Severe Hypoglycemia

Interventions

BIOLOGICAL

Allogeneic Human E-islet (E-islet 01)

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

Sponsors & Collaborators

  • EndoCell Therapeutics, Inc.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07126873 on ClinicalTrials.gov