A Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabete Mellitus; Diabete Type 2
• Intervention / Treatment: Biological: RGB-5088

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Linlin Jiang; Phone Number: +86+571-88601920; Email: linlin.jiang@reprogenix.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Peking University People's Hospital
      • Contact: Linong Ji

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RGB-5088; Transplantation under the anterior rectus sheath	Biological: RGB-5088; Transplantation under the anterior rectus sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety as assessed by number of subjects with adverse events	From RGB-5088 transplantation to end of study (up to 5 years)
Proportion of subjects who are insulin independent	From 90 days to end of study (up to 5 years)
Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%	Up to 5 years post RGB-5088 transplantation

Collaborators and Investigators

• Sponsor: Hangzhou Reprogenix Bioscience, Inc
• Investigators: Principal Investigator: Linong Ji, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2032

Study Registration Dates

• First Submitted: August 26, 2026
• First Submitted That Met QC Criteria: August 26, 2026
• First Posted (Actual): August 31, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: RGB-5088-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No