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

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

April 3, 2025

Primary Completion Date

April 3, 2027

Study Completion Date

October 31, 2027

Conditions
Diabetes Mellitus
Interventions
PROCEDURE

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.

Trial Locations (1)

200032

Zhongshan Hospital, Fudan University, Shanghai

All Listed Sponsors
collaborator

Shanghai Newislet Therapeutics Co., Ltd.

UNKNOWN

lead

Shanghai Zhongshan Hospital

OTHER

NCT06991829 - Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank in Treating Patients With T3c Diabetes | Biotech Hunter | Biotech Hunter