Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
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 criteria
Qualifiers
Diagnosis of CP and scheduled for TP-IAT;
≥18 years old;
Diabetes with HbA1c <12%.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Bone marrow-derived mesenchymal stem cells
- Placebo
Treatment groups
42 Participants
are divided into 3 treatment groupsSponsors and collaborators
Medical University of South Carolina
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov