STEMCAP-1: Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
This protocol aims to test whether an infusion of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) can reduce pain associated with chronic pancreatitis (CP) and explore potential mechanisms of MSC action.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age between 18 and 75 years old, male or female
• Definite chronic pancreatitis
• Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning/remitting.
• Baseline Izbicki pain score \> 30
• Stable dose of opioids for the past 30 days
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
Bridger Scoggins
scoggibr@musc.edu
(843) 792-6388
Time Frame
Start Date: 2024-07-17
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 48
Treatments
Experimental: Experimental Cohort
MSC
Placebo_comparator: Validation Cohort
Placebo
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Medical University of South Carolina