Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorViscofan
About this trial
* The Cardiomesh II clinical trial is a phase I open label study intended to enrol 10 patients to evaluate the safety and efficacy of surgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem cells in patients scheduled to undergo coronary revascularisation surgery and at high risk of developing heart failure. * The primary objective of the study is to evaluate the safety of surgical implantation of this membrane in patients with large ischaemic myocardial scars scheduled to undergo coronary revascularisation surgery. The secondary objective is to investigate the efficacy of the above treatment in terms of reduction of scar size and ventricular function parameters.
Eligibility criteria
Qualifiers
Patients planning to undergo coronary revascularisation surgery within one month of study entry.
LVEF ≤45% by CMRI.
History of myocardial infarction at least 3 months prior to inclusion.
Scar covering at least 15% of the total left ventricular myocardial mass defined by late enhancement on CMRI.
Disqualifiers
Participation in another clinical trial within 30 days prior to inclusion.
Prior treatment with cell or gene therapy.
Be a candidate for heart transplant at the time of study entry.
Diagnosis of acute myocardial infarction with 3 months prior to inclusion.
Trial design
Treatments tested in this trial
- VB-C01 cellularised patch
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach Status unavailable 40-635, Katowice - Ochojec
Poland
PolandSponsors and collaborators
Viscofan
Lead sponsor
KCRI Sp. z o.o.
Collaborator
Medical University of Silesia
Collaborator
Clinica Universidad de Navarra, Universidad de Navarra
Collaborator
Hospital General Universitario Gregorio Marañon
Collaborator
Source ClinicalTrials.gov