Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With Acute Myocardial Infarction (AMI)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

October 20, 2017

Primary Completion Date

July 2, 2020

Study Completion Date

March 31, 2021

Conditions
Myocardial Infarction
Interventions
DRUG

Cardiac Drug

"Patients in the AMI trial will receive one dose of IMP during the index procedure. The IMP administration will be performed by dedicated catheter into infarct related artery.~Active IMP consist of 30 000 000 of Wharton's jelly mesenchymal stem cells (WJMSCs) in each IMP dose prepared for patients randomized into active treatment group."

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)

31-202

The John Paul II Hospital, Krakow

02-507

Central Clinical Hospital of the MSWiA in Warsaw, Warsaw

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

NCT03404063 - Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With Acute Myocardial Infarction (AMI) | Biotech Hunter | Biotech Hunter