50
Participants
Start Date
April 19, 2018
Primary Completion Date
May 31, 2021
Study Completion Date
September 30, 2021
CardioCell
"Patients in the N-O CLI trial will receive a full dose of IMP three times during the trial: at baseline, after 45 days post index administration and after 3 months post index administration.~IMP will be administered into femoral artery and intramuscularly with 50:50 proportion. The intramuscularly dose will be administered into muscles above and below the knee in 50:50 proportion."
Placebos
"Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner.~Control group will receive the same amount of fluid used for WJMSCs preparation, without cells."
Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Katowice
The John Paul II Hospital, Krakow
Collaborators (1)
KCRI
OTHER
National Center for Research and Development, Poland
OTHER
John Paul II Hospital, Krakow
OTHER