Safety and Tolerability Study of Allogeneic Mesenchymal Stem Cell Infusion in Adults With Cystic Fibrosis

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

August 31, 2020

Study Completion Date

August 31, 2020

Conditions
Cystic Fibrosis
Interventions
BIOLOGICAL

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."

Trial Locations (1)

44106

University Hospitals Cleveland Medical Center, Cleveland

All Listed Sponsors
collaborator

Case Western Reserve University

OTHER

collaborator

Cystic Fibrosis Foundation

OTHER

lead

University Hospitals Cleveland Medical Center

OTHER

NCT02866721 - Safety and Tolerability Study of Allogeneic Mesenchymal Stem Cell Infusion in Adults With Cystic Fibrosis | Biotech Hunter | Biotech Hunter