Mesenchymal Stem Cell and Islet Co-transplantation

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Mar 4, 2015

Keywords

ClinConnect Summary

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 in...

Gender

ALL

Eligibility criteria

• 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.