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Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank in Treating Patients With T3c Diabetes
Sponsor: Shanghai Zhongshan Hospital
Summary
Islet cells are isolated from resected pancreatic tissue obtained from patients undergoing surgery, followed by ex vivo expansion and culture. Subsequent procedures include HLA typing, functional assessment of organoid-like structures, and biobanking. After matching for HLA, the cells are administered into patients with type 3c diabetes mellitus (T3cDM) via ultrasound-guided percutaneous transhepatic portal vein catheterization. A 52-week follow-up is conducted to evaluate the safety of the cell therapy and its clinical efficacy in glycemic control.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2025-04-03
Completion Date
2027-10-31
Last Updated
2025-05-28
Healthy Volunteers
No
Conditions
Interventions
HLA-matched pancreatic endocrine organoids transplantation
Islet cells are isolated from resected pancreatic tissue obtained from patients undergoing surgery, followed by ex vivo expansion and culture. Subsequent procedures include HLA typing, functional assessment of organoid-like structures, and biobanking. After matching for HLA, the cells are administered into patients with type 3c diabetes mellitus (T3cDM) via ultrasound-guided percutaneous transhepatic portal vein catheterization. A 52-week follow-up is conducted to evaluate the safety of the cell therapy and its clinical efficacy in glycemic control.
Locations (1)
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China