Autologous Islet Transplantation for Diabetes

NCT ID: NCT07118475

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-07
• Study Completion Date: 2027-05-30

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous islet transplantation

Group Type: EXPERIMENTAL

Autologous islet transplantation

Intervention Type: 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

Interventions

Autologous islet transplantation

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Diabetic patients with islet transplantation indications

2. Dependent on exogenous insulin therapy

3. C-peptide <0.3 ng/ml or blood glucose control remains unsatisfactory despite intensive insulin therapy.

Exclusion Criteria

1. Unable to tolerate transplant related procedures for various reason

2. 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

3. Heart, liver and kidney dysfunction or significant decrease in blood cells

4. Previous cancer history

5. Researcher-deemed ineligible for this clinical trial due to other reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shengli Lin, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

Zhongshan Hospital

Shanghai, , China

Countries

China

Other Identifiers

B2025-257

Identifier Type: -

Identifier Source: org_study_id