Status:
RECRUITING
Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Brittle Type 1 Diabetes Mellitus
Eligibility:
All Genders
6-65 years
Phase:
NA
Brief Summary
This is a single-center, single-arm Phase Investigational Intervention Trial (IIT) clinical trial aimed at evaluating the safety and efficacy of allogeneic regenerative islet transplantation for the t...
Eligibility Criteria
Inclusion
- Age 6-65 years, gender not specified.
- Despite intensified exogenous insulin therapy, blood glucose control remains inadequate \[glycated hemoglobin ≥7.5%, or TIR (time in range) \<70%\].
- Able and willing to use the blood glucose meter provided by the sponsor, conduct self-blood glucose monitoring as required, and complete the patient log as instructed.
- Fertile eligible subjects (male or female) must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose; premenopausal female patients must have a negative pregnancy test before enrollment.
- Diagnosed with type 1 diabetes for at least 1 year based on the World Health Organization (WHO) disease diagnostic criteria, and at least one positive result for diabetes-related autoantibodies \[glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated-2 autoantibody (IA-2A), insulin autoantibody (IAA), islet cell antibody (ICA), zinc transporter 8 antibody (ZaT8A)\]. Experiencing two or more severe hypoglycemic events in the past year, with at least one severe hypoglycemic event in the past 3 months (severe hypoglycemia defined as blood glucose below 2.9 mmol/L or inability to self-correct during hypoglycemia).
- Voluntarily participate and sign the informed consent form.
Exclusion
- Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive human immunodeficiency virus (HIV) testing, and positive syphilis treponemal antibody (TP);
- Presence of significant organic lesions in vital organs such as the heart, lungs, or brain;
- Complications of severe diabetes, including but not limited to retinal hemorrhage, diabetic foot, etc.;
- Liver function tests with total bilirubin, ALT, and AST ≥2×ULN, and failure to normalize after drug treatment;
- Untreated cancer or less than 1 year since cure;
- Severe gastrointestinal dysfunction, gastrointestinal immune diseases, and inability to take immunosuppressant;
- History of smoking, alcohol abuse, or drug misuse;
- Severe mental or psychological disorders;
- Various advanced metabolic diseases (such as hyperuricemia, etc.);
- Participation in other clinical trials in the 3 months prior to enrollment;
- Patients requiring long-term oral/intravenous administration of high-dose glucocorticoids due to various diseases;
- Pregnant or lactating women;
- Investigator judgment indicating clear evidence of severe, active, uncontrolled endocrine or autoimmune abnormalities other than type 1 diabetes;
- Other situations judged by the investigator as unsuitable for participation in the trial.
Key Trial Info
Start Date :
September 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06196996
Start Date
September 14 2021
End Date
September 1 2026
Last Update
January 9 2024
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China