A Clinical Study of iPSC-Derived Islet Cells for Diabetes... | NCT07464119

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

NCT07464119

Sponsor

Peking University First Hospital

Status

Not yet recruiting

Last Update Posted

Mar 11, 2026Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

iPSC-derived islet cell

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 16, 2026Estimated

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2033Estimated

First Submitted Date

Mar 4, 2026

First Submission Date that Met QC Criteria

Mar 9, 2026

First Posted Date

Mar 11, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 11, 2026Actual

Name	Class
Hangzhou Reprogenix Bioscience, Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iPSC-derived islet cell	Experimental		Biological: iPSC-derived islet cell

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iPSC-derived islet cell	Biological	iPSC-derived islet cell infusion	iPSC-derived islet cell

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events		From enrollment to month 6

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital		Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided