Autologous Mesenchymal Stromal Cells and Islet Co-transplantation to Enhance Islet Survival and Function in Chronic Pancreatitis Patients Undergo Total Pancreatectomy and Islet Autotransplantation
Medical University of South Carolina
Summary
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.
Description
This will be a randomized, controlled clinical trial for CP patients scheduled to undergo a TP-IAT surgery. Those who are consented will be randomized into one of three groups. One group will receive islet transplantation alone, a placebo. The other two groups will receive islets plus autologous bone marrow-MSCs at two different doses (20x10\^6/patient, or 50x10\^6/patient). The TP-IAT procedure will remain as routinely performed. Patients will be followed for12 months post-transplantation, having 3 follow-up visits scheduled on days 90, 180, and 365 after the transplant. The primary endpoint…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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);
Interventions
- BiologicalBone marrow-derived mesenchymal stem cells
MSC transplantation
- OtherPlacebo
Standard of Care
Location
- Medical University of South CarolinaCharleston, South Carolina