Mesenchymal Stem Cell and Islet Co-transplantation

Medical University of South Carolina (MUSC)

Status and phase

Completed

Phase 1

Conditions

Chronic Pancreatitis

Diabetes

Treatments

Biological: autologous mesenchymal stromal cell

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02384018

CCT-BMMSC15-001

5R21DK099696 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to show safety and tolerability to our mesenchymal stromal cells (MSCs) product which will be autologous in nature, expanded using a non-xenogeneic, human component expansion media (pooled human platelet lysate) and delivered fresh. Subsequently, the investigators intend to test whether infusion of MSCs immediately after islet autograft can reduce onset of diabetes and improve glycemic control after total pancreatectomy and islet autotransplantation.

Full description

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

Enrollment

3 patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

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.