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Not yet recruiting NCT07464119

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

No phase Interventional Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iPSC-derived islet cell.
Who it may be relevant to
Registry conditions: Diabetes Mellitus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological iPSC-derived islet cell
    iPSC-derived islet cell infusion

Primary outcome measures

  • Adverse events [Time frame: From enrollment to month 6]
Secondary outcome measures (2)
  • Change from baseline in glycosylated hemoglobin (HbA1c) [Time frame: From enrollment to month 6]
  • Change from baseline in exogenous insulin dosage [Time frame: From enrollment to month 6]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Identifiers

NCT: NCT07464119 · RGB-Y0201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗