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Mesenchymal Stem Cell and Islet Co-transplantation

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ClinicalTrials.gov Identifier: NCT02384018
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Medical University of South Carolina

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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.
Study Start Date : December 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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




Primary Outcome Measures :
  1. C-peptide level after mixed meal tolerance test [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Liver function, kidney function [ Time Frame: 12 months after transplant ]
  2. The absence of severe hypoglycemic episodes [ Time Frame: 12 months after transplant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384018


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02384018     History of Changes
Other Study ID Numbers: CCT-BMMSC15-001
5R21DK099696 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases