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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pancreatitis Diabetes||Biological: autologous mesenchymal stromal cell||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- C-peptide level after mixed meal tolerance test [ Time Frame: 12 months ]
- Liver function, kidney function [ Time Frame: 12 months after transplant ]
- The absence of severe hypoglycemic episodes [ Time Frame: 12 months after transplant ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384018
|United States, South Carolina|
|GI Surgery, Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Hongjun Wang, Ph.D||Medical University of South Carolina|