Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank in Treating Patients With T3c Diabetes

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.

NCT Number	NCT06991829
Lead Sponsor	Shanghai Zhongshan Hospital Collaborators: Shanghai Newislet Therapeutics Co., Ltd.
Conditions	Diabetes Mellitus
Enrollment	29 participants
Start Date	2025-04-03
Primary Completion	2027-04-03 (estimated)
Study Completion	2027-10-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-28