Autologous Mesenchymal Stromal Cells and Islet Co-transplantation to Enhance Islet Survival and Function in Chronic Pancreatitis Patients Undergo Total Pancreatectomy and Islet Autotransplantation

Pro00099487

This is a clinical trial for chronic pancreatitis (CP) patients undergoing total pancreatectomy with islet autotransplantation (TP-IAT). Participants will be randomized to either bone marrow-derived mesenchymal stem cells (MSCs) or control with the standard of care. Participants will be followed for one-year post-transplant.

2021-12-01

2026-06-30

2026-06-30

Recruiting

Early phase I

42

Inclusion Criteria: * Diagnosis of CP and scheduled for TP-IAT; * ≥18 years old; * Diabetes with HbA1c \<12%. Exclusion Criteria: * Patients who are under immunosuppression; * Pregnant and breastfeeding women. * Patients who have liver damage based on ALT, AST, and total bilirubin levels (\>3 times normal levels);

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a randomized, controlled clinical trial in which CP patients scheduled for TP-IAT who meet the study criteria and consented will be randomized into three groups. One group will receive islet transplantation alone (n=14). The other two groups will receive islets plus BM-MSCs at two different doses (20x10\\^6/patient, or 50x10\\^6/patient, n=14 in each group).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 42, 'type': 'ESTIMATED'}}

2024-02-29