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

Sponsored by EndoCell Therapeutics, Inc.

About this trial

Last updated 10 months ago

Study ID

ENDOCELL-T1DM-101

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

Accepting

18 to 75 Years

All Sexes

Trial Timing

Started 10 months ago

What is this trial 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

What are the participation requirements?

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