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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    42
  • sponsor
    Medical University of South Carolina
Updated on 14 April 2022

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 IdentifierNCT05095532
SponsorMedical University of South Carolina
Last Modified on14 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of CP and scheduled for TP-IAT
≥18 years old
Diabetes-free before surgery as defined by the standards of the American Diabetes Association
No previous major pancreatic surgeries. Patients who have had minor surgeries including transduodenal sphincteroplasty or Whipple/Beger procedure are eligible

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)
Patients who have had prior pancreatic surgeries including distal pancreatectomy or lateral pancreaticojejunostomy. We have observed that islet yield and function are negatively correlated with these types of pancreatic surgeries
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