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Clinical Trial Summary

The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will receive the placebo.

Clinical Trial Description

The CIHF trial will enroll 105 patients with randomization into active and placebo therapy with 2:1 ratio.

Additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded fashion, labelled CardioCell to determine the early myocardial uptake and retention of IMP.

The primary research question of this project is to check if the administration of CardioCell could improve the clinical outcomes in patients with CIHF. There are several secondary questions, defined by secondary endpoints in each cohort, e.g.: if the investigated treatment is possible to administered, if the investigated treatment and way of CardioCell administration is safe, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03418233
Study type Interventional
Source John Paul II Hospital, Krakow
Contact Piotr Musialek, MD, PhD
Phone +48 12 614 22 87
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date March 31, 2018
Completion date December 31, 2020

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