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

NCT07126873 | Recruiting Phase 1

• 1 other identifier: ENDOCELL-T1DM-101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

  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

  At 1 year after E-islet 01 infusion

Secondary Outcomes (3)

• Proportion of Participants who are Time in range (TIR) >70%

  At 1 year after E-islet 01 infusion

• Number of participants with increase in fasting C-peptide and stimulated C-peptide from baseline

  At 1 year after E-islet 01 infusion

• Proportion of Participants who are Insulin Independent or Reduction in Exogenous Insulin

  At 1 year after E-islet 01 infusion

Study Arms (1)

Allogeneic Human E-islet (E-islet 01)

EXPERIMENTAL

Biological: Allogeneic Human E-islet (E-islet 01)

Interventions

Allogeneic Human E-islet (E-islet 01) BIOLOGICAL

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

Allogeneic Human E-islet (E-islet 01)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical history of Type 1 Diabetes with \> 5 years of duration
• 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:
• At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EndoCell Therapeutics, Inc.: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

yanyan ma

CONTACT

+8618621591910; mayanyan@endocell.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 17, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CN (1)