RecruitingPhase 1NCT05095532

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

Autologous Mesenchymal Stromal Cells and Islet Co-transplantation to Enhance Islet Survival and Function in Chronic Pancreatitis Patients Undergo Total Pancreatectomy and Islet Autotransplantation


Sponsor

Medical University of South Carolina

Enrollment

42 participants

Start Date

Dec 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Diagnosis of CP and scheduled for TP-IAT;
  • ≥18 years old;
  • Diabetes with HbA1c <12%.

Exclusion Criteria3

  • 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);

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Interventions

BIOLOGICALBone marrow-derived mesenchymal stem cells

MSC transplantation

OTHERPlacebo

Standard of Care


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT05095532


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