E-islet 01 therapy for people with long-standing Type 1 diabetes and impaired hypoglycemia awareness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional trial enrolls participants with Type 1 diabetes for at least five years, very low C-peptide, and either impaired hypoglycemia awareness or recent severe hypoglycemia to receive allogeneic human E-islet 01. The protocol focuses on safety and tolerability while tracking effects on hypoglycemia frequency and metabolic markers such as mixed-meal stimulated C-peptide. Eligible participants must be on continuous insulin therapy and able to perform frequent self-blood glucose monitoring, and those with active systemic infections or recent malignancy are excluded. Follow-up visits and safety/efficacy assessments are conducted at the single study site in Shanghai.

Why it matters

Who can join: the full rules

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

Where it's running

• Shanghai Changzheng Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: yanyan ma
• Email: mayanyan@endocell.cn
• Phone: +8618621591910

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.