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

EndoCell Therapeutics, Inc.

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Impaired Hypoglycemic Awareness

Diabetes Mellitus, Type 1

Severe Hypoglycemia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07126873

ENDOCELL-T1DM-101

Details and patient eligibility

About

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

Enrollment

21 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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