Mesenchymal Stem Cell and Islet Co-transplantation

March 23, 2022 updated by: Hongjun Wang, Medical University of South Carolina

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • GI Surgery, Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients will receive standard islet transplantation.
Experimental: autologous mesenchymal stromal cell
Patients will receive MSCs together with standard islet transplantation.
Biological: autologous mesenchymal stromal cell
Islet transplantation patients will receive autologous MSCs following islets infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
C-peptide level after mixed meal tolerance test
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Liver function, kidney function
Time Frame: 12 months after transplant
12 months after transplant
The absence of severe hypoglycemic episodes
Time Frame: 12 months after transplant
12 months after transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

November 21, 2017

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCT-BMMSC15-001
  • 5R21DK099696 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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