Mesenchymal Stem Cell and Islet Co-transplantation

Sponsor

Medical University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT02384018

Collaborator

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

Enrollment

Location

Arms

35.7

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis Diabetes	Biological: autologous mesenchymal stromal cell	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Nov 21, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

C-peptide level after mixed meal tolerance test [12 months]

Secondary Outcome Measures

Liver function, kidney function [12 months after transplant]
The absence of severe hypoglycemic episodes [12 months after transplant]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GI Surgery, Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hongjun Wang, Professor of Surgery, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT02384018

Other Study ID Numbers:

CCT-BMMSC15-001
5R21DK099696

First Posted:

Mar 10, 2015

Last Update Posted:

Apr 4, 2022

Last Verified:

Mar 1, 2022

Additional relevant MeSH terms:

Pancreatitis

Pancreatitis, Chronic

Study Results

No Results Posted as of Apr 4, 2022