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

Chronic Pancreatitis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 will be a change in islet function from baseline to 12 months post-transplantation as measured by the C-peptide area under the curve following a mixed meal tolerance test. Potential effects of MSCs on glycemic control, pain relief, quality of life, and adverse events will be evaluated at each follow-up visit. ;

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Mesenchymal Stem Cells
• Pancreatitis
• Pancreatitis, Chronic

• NCT number: NCT05095532
• Study type: Interventional
• Source: Medical University of South Carolina
• Contact: Leah Benn, MPH
• Phone: 843-792-2813
• Email: bennle@musc.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2021
• Completion date: June 30, 2026