Chronic pancreatitis (CP) is a disease in which long-standing inflammation of the pancreas alters the normal structure and function of the pancreas. Total Pancreatectomy and islet autotransplantation (TP-IAT) is currently being performed to increase patients’ quality of life and ameliorate post-operative diabetes in well-selected CP patients. There is a dramatic loss of beta cell mass after islet transplantation caused mainly by stresses during islet harvest and post transplantation. The goal of this clinical trial is to find out if co-transplantation of autologous mesenchymal stromal cells (also called MSCs) with islets can improve islet cell survival after TP-IAT.
This trial will enroll 42 CP patients scheduled for TP-IAT. Participants who meet the study criteria and consent to this study will be randomized into three groups. One group will receive islet transplantation alone. The other two groups will receive islets plus MSCs at two different doses. Potential effects of MSC on islet function, glycemic control, pain relief, quality of life, and adverse events will be determined. All participants will receive standard of care.
The clinical trial registration number for this study is NCT02384018.