RGB-5088: Transplantation under the anterior rectus sheath
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Diagnosis of any form of diabetes other than T2DM.
* Daily insulin dose \>1.5 U/kg or total daily dose \<20 U.
* Fasting plasma glucose ≥15.0 mmol/L.
* Positive for any diabetes-related autoantibodies at screening (prior to adipose tissue collection).
* Proliferative diabetic retinopathy requiring treatment or unstable.
* 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.
* Clinically significant abnormal liver function tests.
* Clinically significant abnormal renal function tests.
* Clinically significant abnormalities in hematology parameters.
* Positive pregnancy test; breastfeeding.
* 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.
* Use of concomitant medications (other than current antidiabetic agents) that, in the Investigator's opinion, may interfere with glycemic control.
* 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.
* 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.
* Judged by the Investigator to have poor compliance or unwillingness to adhere to study procedures.
Primary outcome measure(s)
Safety as assessed by number of subjects with adverse events — From RGB-5088 transplantation to one year later
Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1% — On Day180 post RGB-5088 transplantation
Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1% — On Day365 post RGB-5088 transplantation
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
Beijing Municipality
More Hangzhou Reprogenix Bioscience, Inc trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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