Mesenchymal Stem Cell and Islet Co-transplantation

This is a Phase I study evaluating safety and tolerability of autologous BM-MSCs in chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation (TP-IAT). CCT-BMMSC will be infused at one of the following doses: (Tier 1), 20x10^6 cell per patient, (Tier 2), 50x10^6 cell per patient, and (Tier 3), 100x10^6 cell per patient.

Primary objective: To describe and compare the safety and tolerability of infusion of fresh autologous bone marrow-derived Mesenchymal stromal cells after islet transplantation in chronic pancreatitis patients who undergo TP-IAT. The investigators plan to enroll 24 patients for the whole study. The duration of this study is 12 months. The investigators anticipate that this study will be completed within 2 years of commencement.

Secondary objective: Efficacy of infusion of fresh autologous bone marrow-derived Mesenchymal stromal cells together after islet transplantation in chronic pancreatitis patients who undergo TP-IAT as assessed through onset of diabetes, glycemic control, pain relief and quality of life index.

Safety variables: Adverse events (AEs), Laboratory parameters (hematology, biochemistry, urinalysis), Vital signs

Inclusion criteria

• Chronic pancreatitis patients who undergo TP-IAT.
• >18 years of age.
• Patients with BMI from 18.5 to 30.
• Renal function: >90mls/min/1.73m squared
• Normal INR/PT/PTT values for MUSC clinical laboratory standards
• Diabetes free before surgery (fasting blood glucose<125mg/dl).
• No prior pancreatic surgery with the exception of transduodenal sphincteroplasty or Whipple/Beger procedure.
• Patients with normal liver function as measured by serum levels of aminotransferase including alanine aminotransferase (ALT), and aspartate aminotransferase (AST), and total bilirubin levels.

Exclusion criteria

• Patients whose Hemoglobin, Hematocrit, and Platelet count are above or below normal values for MUSC clinical laboratory standards.
• Patients who has hematological malignancy.
• Patients who are under immunosuppression.
• Patients with marked calcification disease on CT scan.
• Patients with severe fibrosis and atrophy on pancreas MRI.