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

NCT ID: NCT07126873

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-11
• Study Completion Date: 2029-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Allogeneic Human E-islet (E-islet 01)

Group Type: EXPERIMENTAL

Allogeneic Human E-islet (E-islet 01)

Intervention Type: BIOLOGICAL

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

Interventions

Allogeneic Human E-islet (E-islet 01)

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EndoCell Therapeutics, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

yanyan ma

Role: CONTACT

mayanyan@endocell.cn

+8618621591910

Facility Contacts

Hao Yin

Role: primary

yinhaoshanghai@163.com

13901677738

Other Identifiers

ENDOCELL-T1DM-101

Identifier Type: -

Identifier Source: org_study_id