NCT07118475

Autologous Islet Transplantation for Diabetes

Exploratory Clinical Study of Adult Pancreatic Progenitor-derived Islet Autologous Transplantation in the Treatment of Diabetes

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 Mellitus, Type 2

Interventions

Type	Name	Description
BIOLOGICAL	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

Timeline

• Start date: 2025-10-07
• Primary completion: 2027-05-30
• Completion: 2027-05-30
• First posted: 2025-08-12
• Last updated: 2026-04-06

Locations

1 site across 1 country: China