14
Participants
Start Date
August 31, 2016
Primary Completion Date
August 31, 2020
Study Completion Date
August 31, 2020
Mesenchymal Stem Cells
"A single dose, one time infusion (in the vein) of one of the following doses of human mesenchymal stem cells (hMSCs): 1 x 10\^6, 3 x 10\^6 or 5 x 10\^6 human mesenchymal stem cells per kilogram body weight (hMSCs/kg) during Visit 2. A traditional 3+3 design will be utilized.~Allogeneic mesenchymal stem cells (MSCs) will be derived from bone marrow aspirates from a healthy donor whose serum tests negative for cytomegalovirus (CMV) antibodies. Healthy donors will undergo tests for infectious disease and screening for 41 common cystic fibrosis transmembrane conductance regulator (CFTR) mutations. In addition, the MSCs will be validated for in vitro and in vivo efficacy and potency using the in vivo murine pre-clinical model of cystic fibrosis lung infection and inflammation."
University Hospitals Cleveland Medical Center, Cleveland
Case Western Reserve University
OTHER
Cystic Fibrosis Foundation
OTHER
University Hospitals Cleveland Medical Center
OTHER