Transplanting stem cells with islets for chronic pancreatitis patients
Autologous Mesenchymal Stromal Cells and Islet Co-transplantation to Enhance Islet Survival and Function in Chronic Pancreatitis Patients Undergo Total Pancreatectomy and Islet Autotransplantation
This study is testing whether adding stem cells to islet transplants can improve blood sugar control and reduce pain for people with chronic pancreatitis who are having surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05095532 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of autologous bone marrow-derived mesenchymal stem cells (MSCs) in patients with chronic pancreatitis undergoing total pancreatectomy with islet autotransplantation (TP-IAT). Participants will be randomly assigned to receive either islet transplantation alone or islets combined with MSCs at two different doses. The study aims to evaluate changes in islet function, glycemic control, pain relief, and quality of life over a 12-month follow-up period. The primary endpoint is the change in islet function measured by C-peptide levels after a mixed meal tolerance test.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with chronic pancreatitis who are scheduled for total pancreatectomy with islet autotransplantation.
Not a fit: Patients currently under immunosuppression, pregnant or breastfeeding women, or those with significant liver damage will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance islet function and improve the quality of life for patients with chronic pancreatitis.
How similar studies have performed: While the use of MSCs in transplantation is a growing area of interest, this specific combination approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of CP and scheduled for TP-IAT; * ≥18 years old; * Diabetes with HbA1c \<12%. Exclusion Criteria: * Patients who are under immunosuppression; * Pregnant and breastfeeding women. * Patients who have liver damage based on ALT, AST, and total bilirubin levels (\>3 times normal levels);
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Hongjun Wang — Medical University of South Carolina
- Study coordinator: Leah Benn, MPH
- Email: bennle@musc.edu
- Phone: 843-792-2813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.