Islet transplantation for brittle type 1 diabetes

Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus: A Clinical Study Evaluating Safety and Efficacy

This study is testing if islet transplantation can help people with brittle type 1 diabetes better control their blood sugar levels after struggling with insulin therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 6 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Changzheng Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06196996 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of allogeneic regenerative islet transplantation in patients with brittle type 1 diabetes mellitus who struggle with blood glucose control despite intensive insulin therapy. Eighteen participants aged 6 to 65 will undergo islet transplantation via a percutaneous transhepatic portal vein puncture. The primary goal is to assess improvements in blood glucose levels and overall safety over a 12-month period following the procedure.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 6 to 65 with brittle type 1 diabetes who have inadequate blood glucose control despite intensified insulin therapy.

Not a fit: Patients who do not have brittle type 1 diabetes or those who have well-controlled diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve blood glucose control and quality of life for patients with brittle type 1 diabetes.

How similar studies have performed: While islet transplantation has been explored in other studies, the specific approach of regenerative islet transplantation for brittle type 1 diabetes is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age 6-65 years, gender not specified.
2. Despite intensified exogenous insulin therapy, blood glucose control remains inadequate \[glycated hemoglobin ≥7.5%, or TIR (time in range) \<70%\].
3. 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.
4. 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.
5. 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).
6. Voluntarily participate and sign the informed consent form.

Exclusion Criteria:

1. 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);
2. Presence of significant organic lesions in vital organs such as the heart, lungs, or brain;
3. Complications of severe diabetes, including but not limited to retinal hemorrhage, diabetic foot, etc.;
4. Liver function tests with total bilirubin, ALT, and AST ≥2×ULN, and failure to normalize after drug treatment;
5. Untreated cancer or less than 1 year since cure;
6. Severe gastrointestinal dysfunction, gastrointestinal immune diseases, and inability to take immunosuppressant;
7. History of smoking, alcohol abuse, or drug misuse;
8. Severe mental or psychological disorders;
9. Various advanced metabolic diseases (such as hyperuricemia, etc.);
10. Participation in other clinical trials in the 3 months prior to enrollment;
11. Patients requiring long-term oral/intravenous administration of high-dose glucocorticoids due to various diseases;
12. Pregnant or lactating women;
13. Investigator judgment indicating clear evidence of severe, active, uncontrolled endocrine or autoimmune abnormalities other than type 1 diabetes;
14. Other situations judged by the investigator as unsuitable for participation in the trial.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Hao Yin — Shanghai Changzheng Hospital
• Study coordinator: Hao Yin

Conditions Brittle Type 1 Diabetes Mellitus