Mesenchymal Stem Cell and Islet Co-transplantation

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Brief Title

Mesenchymal Stem Cell and Islet Co-transplantation

Official Title

A Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow-derived Mesenchymal Stromal Cells in Chronic Pancreatitis Patients Who Undergo Total Pancreatectomy and Islet Autotransplantation.

Brief Summary

      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.
    

Detailed 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
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

C-peptide level after mixed meal tolerance test

Secondary Outcome

 Liver function, kidney function

Condition

Chronic Pancreatitis

Intervention

autologous mesenchymal stromal cell

Study Arms / Comparison Groups

 Control
Description:  Patients will receive standard islet transplantation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

42

Start Date

December 2014

Completion Date

December 2026

Primary Completion Date

December 2026

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.
      

Gender

All

Ages

18 Years - 69 Years

Accepts Healthy Volunteers

No

Contacts

Hongjun Wang, Ph.D, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02384018

Organization ID

CCT-BMMSC15-001

Secondary IDs

5R21DK099696

Responsible Party

Sponsor

Study Sponsor

Medical University of South Carolina

Collaborators

 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Sponsor

Hongjun Wang, Ph.D, Principal Investigator, Medical University of South Carolina


Verification Date

December 2020