Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI)

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 19, 2018

Primary Completion Date

May 31, 2021

Study Completion Date

September 30, 2021

Conditions
Critical Limb Ischemia
Interventions
DRUG

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."

DRUG

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."

Trial Locations (2)

40-635

Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Katowice

31-202

The John Paul II Hospital, Krakow

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

KCRI

OTHER

collaborator

National Center for Research and Development, Poland

OTHER

lead

John Paul II Hospital, Krakow

OTHER

NCT03423732 - Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI) | Biotech Hunter | Biotech Hunter