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

September 2, 2026 updated by: Hangzhou Reprogenix Bioscience, Inc

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety as assessed by number of subjects with adverse events
Time Frame: From RGB-5088 transplantation to one year later
From RGB-5088 transplantation to one year later
Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%
Time Frame: On Day180 post RGB-5088 transplantation
On Day180 post RGB-5088 transplantation
Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%
Time Frame: On Day365 post RGB-5088 transplantation
On Day365 post RGB-5088 transplantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety as assessed by number of subjects with adverse events
Time Frame: From RGB-5088 transplantation to end of study (up to 5 years)
From RGB-5088 transplantation to end of study (up to 5 years)
Proportion of subjects who are insulin independent
Time Frame: From 90 days to end of study (up to 5 years)
From 90 days to end of study (up to 5 years)
Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%
Time Frame: Up to 5 years post RGB-5088 transplantation
Up to 5 years post RGB-5088 transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Reprogenix Bioscience, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linong Ji, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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