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Mesenchymal Stem Cell and Islet Co-transplantation

Primary Purpose

Chronic Pancreatitis, Diabetes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
autologous mesenchymal stromal cell
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pancreatitis

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • GI Surgery, Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

autologous mesenchymal stromal cell

Arm Description

Patients will receive standard islet transplantation.

Patients will receive MSCs together with standard islet transplantation.

Outcomes

Primary Outcome Measures

C-peptide level after mixed meal tolerance test

Secondary Outcome Measures

Liver function, kidney function
The absence of severe hypoglycemic episodes

Full Information

First Posted
December 16, 2014
Last Updated
March 23, 2022
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02384018
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
November 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will receive standard islet transplantation.
Arm Title
autologous mesenchymal stromal cell
Arm Type
Experimental
Arm Description
Patients will receive MSCs together with standard islet transplantation.
Intervention Type
Biological
Intervention Name(s)
autologous mesenchymal stromal cell
Intervention Description
Islet transplantation patients will receive autologous MSCs following islets infusion
Primary Outcome Measure Information:
Title
C-peptide level after mixed meal tolerance test
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Liver function, kidney function
Time Frame
12 months after transplant
Title
The absence of severe hypoglycemic episodes
Time Frame
12 months after transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongjun Wang, Ph.D
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
GI Surgery, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29159905
Citation
Wang H, Strange C, Nietert PJ, Wang J, Turnbull TL, Cloud C, Owczarski S, Shuford B, Duke T, Gilkeson G, Luttrell L, Hermayer K, Fernandes J, Adams DB, Morgan KA. Autologous Mesenchymal Stem Cell and Islet Cotransplantation: Safety and Efficacy. Stem Cells Transl Med. 2018 Jan;7(1):11-19. doi: 10.1002/sctm.17-0139. Epub 2017 Nov 21.
Results Reference
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Mesenchymal Stem Cell and Islet Co-transplantation

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