A Clinical Study of iPSC-Derived Islet Cells for Diabetes Mellitus Therapy

March 9, 2026 updated by: Zhang Junqing, Peking University First Hospital

A Single-Arm, Open-Label Clinical Study of iPSC-Derived Islet Cells for the Treatment of Diabetes Mellitus

This is a single-arm, open-label clinical trial designed to assess the safety and therapeutic efficacy of iPSC-derived islet cell infusion in patients with diabetes mellitus.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Subjects aged 18 years or older, of any sex.
  • Duration of diabetes > 5 years.
  • Body mass index (BMI) 18-35 kg/m².
  • Receiving insulin therapy.

Key Exclusion Criteria:

  • Presence of HIV infection , or active acute or chronic hepatitis infection (HBV or HCV), or Treponema pallidum infection.
  • Active pulmonary tuberculosis or patients undergoing treatment for suspected tuberculosis.
  • Uncontrolled systemic fungal, bacterial, viral, or other infections .
  • Presence of severe diabetic complications.
  • Presence of severe organic lesions in vital organs such as the heart, lungs, or brain.
  • History of malignant tumors.

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: iPSC-derived islet cell
Biological: iPSC-derived islet cell
iPSC-derived islet cell infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: From enrollment to month 6
From enrollment to month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in glycosylated hemoglobin (HbA1c)
Time Frame: From enrollment to month 6
From enrollment to month 6
Change from baseline in exogenous insulin dosage
Time Frame: From enrollment to month 6
From enrollment to month 6

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

Collaborators

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 (Estimated)

March 16, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGB-Y0201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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