RGB-5088 islet cell transplantation for Type 1 diabetes

A Single-Center, Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 1 Diabetes Mellitus

This trial will test whether transplanted RGB-5088 islet cells can safely reduce severe hypoglycemia and lower insulin needs in adults with Type 1 diabetes and very low C-peptide.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Hangzhou Reprogenix Bioscience, Inc (industry)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06731218 on ClinicalTrials.gov

What this trial studies

This is a Phase I, single-center, single-arm, open-label trial of RGB-5088 islet cell transplantation in adults with Type 1 diabetes. The study enrolls patients aged 18–60 with stimulated C-peptide < 0.3 ng/mL who have had at least one severe hypoglycemic episode in the prior 12 months. Participants will receive RGB-5088 transplantation and undergo close monitoring for safety, changes in C-peptide, insulin requirements, and episodes of hypoglycemia. The main goal is to characterize safety and early signals of therapeutic effect to guide further development.

Who should consider this trial

Good fit: Adults 18–60 years old with Type 1 diabetes, stimulated C-peptide below 0.3 ng/mL, and at least one severe hypoglycemic event in the past year who meet the study's medical and contraceptive requirements are the intended participants.

Not a fit: People with Type 2 diabetes, untreated proliferative diabetic retinopathy, serious cardiac or gastrointestinal disease, active malignancy, substance abuse, or pregnant or breastfeeding women are not likely to benefit or are excluded from participation.

Why it matters

Potential benefit: If successful, RGB-5088 transplantation could reduce severe hypoglycemia and lower daily insulin requirements by restoring some endogenous insulin production.

How similar studies have performed: Previous islet cell transplantation approaches have shown short-term success in reducing severe hypoglycemia and insulin needs for some patients but often require immunosuppression and rarely produce durable, long-term insulin independence.

Eligibility criteria

Key Inclusion Criteria:

* Age: 18-60 years old (including 18 and 60 years old), male and female;
* Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney);
* Stimulated C-peptide \< 0.3 ng/mL;
* The patient had at least one severe hypoglycemia within 12 months before being included in the project

Key Exclusion Criteria:

* Type 2 diabetes patients;
* Untreated proliferative diabetes retinopathy;
* Serious heart disease;
* Serious gastrointestinal dysfunction ；
* Serious psychological diseases；
* Any history of malignancy;
* Have a history of tobacco, alcohol and drug abuse;
* For female subjects: pregnancy test positive, lactation or unwilling to use effective contraceptive measures during the study period, male patients: intent to procreate or unwilling to use effective contraceptive measures during the study period.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin First Center Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Linlin Jiang

Conditions: Diabetes Mellitus, Type 1, Diabetes Mellitus