Autologous Mesenchymal Stromal Cells and Islet Co-transplantation to Enhance Islet Survival and Function in Chronic Pancreatitis Patients Undergo Total Pancreatectomy and Islet Autotransplantation
Who is this study for? Patients with Chronic Pancreatitis
What treatments are being studied? Bone Marrow-Derived Mesenchymal Stem Cells
Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of CP and scheduled for TP-IAT;
• ≥18 years old;
• Diabetes with HbA1c \<12%.
Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Leah Benn, MPH
bennle@musc.edu
843-792-2813
Backup
Kelsey Cook
conder@musc.edu
843 876 0420
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 42
Treatments
Experimental: BM-MSCs at 20x10^6
One time infusion of islets plus BM-MSCs at 20x10\^6/patient, n=14
Experimental: BM-MSCs at 50x10^6
One time infusion of islets plus BM-MSCs at 50x10\^6/patient, n=14
Placebo_comparator: Placebo
One time infusion of islets only.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Medical University of South Carolina