Autologous Islet Transplantation for Diabetes

NCT07118475 | Enrolling By Invitation Early Phase 1

• 1 other identifier: B2025-257
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to conduct an exploratory clinical trial recruiting insulin-dependent diabetic patients who meet the criteria for islet transplantation. Pancreatic tissue will be obtained via endoscopic ultrasound-guided fine-needle aspiration biopsy, and adult pancreatic progenitor cells (APP) will be expanded in vitro and differentiated into islet-like cells. After quality assessment, these cells will be transplanted via injection beneath the anterior rectus sheath. Following autologous transplantation of APP-derived islets, the transplanted islets are expected to survive at the implantation site, stably secrete insulin, and thereby reduce or potentially eliminate the need for exogenous insulin. Glycated hemoglobin (HbA1c) levels are anticipated to decrease, with a significant reduction in the risk of severe hypoglycemic episodes, and no transplant-related adverse events are expected. As this is an exploratory clinical study, participants may not benefit from APP islet transplantation and may face risks or adverse events associated with the procedure. However, the findings of this research may advance more scientific and effective treatment strategies for diabetes. The successful completion of this study could provide a feasible and scalable approach to functionally curing diabetes, effectively reducing disability and mortality rates among diabetic patients, improving their quality of life, and generating substantial health, economic, and social benefits.

Conditions

Diabetes (Insulin-requiring, Type 1 or Type 2)

Keywords

diabetes; islet transplantation; adult pancreatic progenitor

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Adverse events will be coded according to the MedDRA dictionary, and AE will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 of the National Cancer Institute.

  Within one year after transplant

• Hypoglycemia incidence rate

  Hypoglycemia can be divided into three levels based on blood sugar levels, physical changes, and state of consciousness.

  Within one year after transplant

Secondary Outcomes (6)

• Changes in glycosylated hemoglobin (HbA1c) from baseline at 3 months, 6 months, 9 months, and 1 year after transplantation

  Within one year after transplant

• Changes in time in range (TIR) at 3 months, 6 months, 9 months, and 1 year post-transplantation compared to baseline

  Within one year after transplant

• Changes in fasting plasma glucose at 3 months, 6 months, 9 months, and 1 year post-transplantation compared to baseline

  Within one year after transplant

• Changes in insulin at 3 months, 6 months, 9 months, and 1 year post-transplantation compared to baseline

  Within one year after transplant

• Changes in C-peptide at 3 months, 6 months, 9 months, and 1 year post-transplantation compared to baseline

  Within one year after transplant

Study Arms (1)

Autologous islet transplantation

EXPERIMENTAL

Biological: Autologous islet transplantation

Interventions

Autologous islet transplantation BIOLOGICAL

1. EUS-FNB or surgical procurement of pancreatic tissue 2. In vitro culture of adult pancreatic progenitor 3. In vitroinduction of islets 4. islet transplantation beneath the anterior rectus sheath 5. Post-transplant follow-up

Autologous islet transplantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients with islet transplantation indications
• Dependent on exogenous insulin therapy
• C-peptide \<0.3 ng/ml or blood glucose control remains unsatisfactory despite intensive insulin therapy.

You may not qualify if:

• Unable to tolerate transplant related procedures for various reason
• Persons with a history of infectious diseases such as hepatitis B, hepatitis C, HIV and tuberculosis, or persons with active bacterial, fungal or viral infection
• Heart, liver and kidney dysfunction or significant decrease in blood cells
• Previous cancer history
• Researcher-deemed ineligible for this clinical trial due to other reasons.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shengli Lin, Doctor

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From study publication to 5 years post-study
• Access Criteria: For academic inquiries or research collaboration, interested investigators may contact the Principal Investigator, Professor Shengli Lin, via email.

Locations

CN (1)