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NCT Number: NCT07464119

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iPSC-derived islet cell

Biological

iPSC-derived islet cell infusion

Primary outcomes

  1. Adverse events

    Time frame: From enrollment to month 6

Secondary outcomes

  1. Change from baseline in glycosylated hemoglobin (HbA1c)

    Time frame: From enrollment to month 6

  2. Change from baseline in exogenous insulin dosage

    Time frame: From enrollment to month 6

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Hangzhou Reprogenix Bioscience, Inc

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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