NCT07464119

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
93mo left

Started Mar 2026

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Mar 2026Dec 2033

First Submitted

Initial submission to the registry

March 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

March 4, 2026

Last Update Submit

March 9, 2026

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    From enrollment to month 6

Secondary Outcomes (2)

  • Change from baseline in glycosylated hemoglobin (HbA1c)

    From enrollment to month 6

  • Change from baseline in exogenous insulin dosage

    From enrollment to month 6

Study Arms (1)

iPSC-derived islet cell

EXPERIMENTAL
Biological: iPSC-derived islet cell

Interventions

iPSC-derived islet cellBIOLOGICAL

iPSC-derived islet cell infusion

iPSC-derived islet cell

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 11, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2033

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)