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 ]
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
|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|