Testing RGB-5088 islet cell injection in adults with type 2 diabetes
Tests RGB-5088 islet cell injection in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: A Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 2 Diabetes Mellitus
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07794254, who can take part
Where in China
- Peking University People's HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hangzhou Reprogenix Bioscience, Inc
- Trial code
- NCT07794254
- Record updated
- 8 September 2026
- Original description
This Phase I clinical trial is a multi-center, single-arm, open-label study aimed at evaluating the safety and efficacy of RGB-5088 islet cell infusion in patients with Type 2 Diabetes Mellitus.Read full original descriptionShow less
A Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 2 Diabetes Mellitus
This Phase I clinical trial is a multi-center, single-arm, open-label study aimed at evaluating the safety and efficacy of RGB-5088 islet cell infusion in patients with Type 2 Diabetes Mellitus.
Inclusion: Age 18-65 years (inclusive), male or female; Diagnosis of type 2 diabetes mellitus (T2DM) with a disease duration ≥5 years; Body mass index (BMI) 18-30 kg/m²; Glycated hemoglobin (HbA1c) 7.0%-10.0%; Adherence to guideline-recommended diet and exercise control; willing and able to comply with lifestyle interventions throughout the study; On insulin therapy following adequate trials of standard and advanced glucose-lowering regimens as per guidelines; Subjects are dependent on insulin therapy; Women of childbearing potential, or male participants whose partners are of childbearing potential, must agree to use highly effective contraception throughout the study and for at least 6 months post-treatment; Able to understand the study protocol, willing to participate voluntarily, and provide signed written informed consent.
Exclusion: Positive for any diabetes-related autoantibodies at screening (prior to adipose tissue collection); Use of concomitant medications (other than current antidiabetic agents) that, in the Investigator's opinion, may interfere with glycemic control; Participation in another interventional clinical trial within 3 months prior to signing the Informed Consent Form; Prior islet cell infusion/transplantation; Receipt of any other stem cell therapy; Diagnosis of any form of diabetes other than T2DM; Active infection; hepatitis B, hepatitis C, syphilis, HIV antibody positivity; or history of tuberculosis; History of major cardiovascular or cerebrovascular disease; Uncontrolled hypertension despite pharmacological therapy; History of malignant tumor, except for malignancies with an excellent expected prognosis after curative treatment; History of tobacco dependence, alcohol abuse, substance abuse, or illicit drug use; Any active autoimmune disease or history of autoimmune disease deemed by the Investigator to be incompatible with study participation; Documented history of a psychiatric disorder; History of hemoglobinopathy, other significant hematological disorders, or any condition causing hemolysis or erythrocyte instability; Fasting plasma glucose ≥15.0 mmol/L; Daily insulin dose >1.5 U/kg or total daily dose <20 U; Proliferative diabetic retinopathy requiring treatment or unstable; Clinically significant abnormal liver function tests; Clinically significant abnormal renal function tests; Clinically significant abnormalities in hematology parameters; Positive pregnancy test; breastfeeding; Judged by the Investigator to have poor compliance or unwillingness to adhere to study procedures.