Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus

September 9, 2025 updated by: Hangzhou Reprogenix Bioscience, Inc

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 Phase I clinical trial is a single-center, single-arm, open-label study aimed at evaluating the safety and therapeutic efficacy of RGB-5088 islet cell transplantation in patients with Type 1 Diabetes Mellitus.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • 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 Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Recruiting
        • Tianjin First Center Hospital
        • Principal Investigator:
          • Shusen Wang
        • Contact:
        • Principal Investigator:
          • Zhongyang Shen

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

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
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
Time Frame: From RGB-5088 transplantation to one year later
From RGB-5088 transplantation to one year later
Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events
Time Frame: From 90 days to 365 days after RGB-5088 transplantation
From 90 days to 365 days after RGB-5088 transplantation

Secondary Outcome Measures

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 with HbA1c ≤ 6.5% and free of severe hypoglycemic events
Time Frame: From 90 days to end of study (up to 5 years)
From 90 days to end of study (up to 5 years)

Collaborators and Investigators

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

Sponsor

Hangzhou Reprogenix Bioscience, Inc

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 (Actual)

February 17, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 12, 2024

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGB-5088-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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