Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT
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- STATUS
- Recruiting
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- End date
- Jun 30, 2026
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- participants needed
- 42
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- sponsor
- Medical University of South Carolina
Summary
This is a clinical trial for non-diabetic 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.
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.
Details
| Condition | Chronic Pancreatitis, Mesenchymal Stem Cells |
|---|---|
| Treatment | Placebo, Bone marrow-derived mesenchymal stem cells |
| Clinical Study Identifier | NCT05095532 |
| Sponsor | Medical University of South Carolina |
| Last Modified on | 14 April 2022 |
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