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iPSC-Derived Islet Cells for Diabetes Mellitus Treatment

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Study Aim

This study aims to treat Diabetes Mellitus by using iPSC-derived islet cells, with a primary focus on monitoring any adverse events.

What is being tested

iPSC-derived islet cell

Biological
Who is being recruted

Diabetes Mellitus+2

+ Endocrine System Diseases

+ Metabolic Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorPeking University First Hospital
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 16, 2026

Actual date on which the first participant was enrolled.

This clinical study focuses on treating diabetes mellitus using a unique approach. It involves the use of islet cells, which are special cells that produce insulin, a hormone that helps regulate blood sugar levels. These islet cells are derived from iPSCs, a type of stem cell that can transform into any cell type in the body. The study aims to help patients with diabetes mellitus, a condition where the body cannot produce enough insulin or use it effectively. The goal is to evaluate if these iPSC-derived islet cells can provide a safe and effective treatment method, potentially improving care for those living with this condition. During the study, participants receive an infusion of the iPSC-derived islet cells. The study is open-label, meaning everyone involved knows about the treatment being used. The primary outcome measured is any adverse events or side effects that may occur. This helps determine the safety of the treatment. The study does not specify a phase, indicating it could be early in the research process.

Official TitleA Single-Arm, Open-Label Clinical Study of iPSC-Derived Islet Cells for the Treatment of Diabetes Mellitus
Principal SponsorPeking University First Hospital
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

6 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Peking University First Hospital

Beijing, ChinaOpen Peking University First Hospital in Google Maps
Recruiting soonOne Study Center