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

What this Trial Is About

The trial investigates patients with chronic pancreatitis undergoing total pancreatectomy with islet autotransplantation (TP-IAT). It evaluates the use of bone marrow-derived mesenchymal stem cells (MSCs) compared to standard care and placebo to study their effects on islet survival and function after surgery. This is a randomized, controlled phase 1 clinical trial aiming to understand how MSCs may impact outcomes for these patients. Participants will be randomly assigned to one of three groups: one group receives islet transplantation alone (placebo), and the other two groups receive islets combined with autologous bone marrow MSCs at two different doses (20 million or 50 million cells per patient). The TP-IAT surgery remains standard for all. The MSC or placebo infusion is given once during the transplant procedure. After the surgery, participants will be followed for 12 months with scheduled visits at 90, 180, and 365 days. Researchers will measure changes in islet cell function using a mixed meal tolerance test and C-peptide levels. They will also evaluate blood sugar control, insulin use, pain relief, quality of life, and any adverse events during follow-up. The total participation time is one year post-transplant.

Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT