EXCELLENT (EXpanded CELL ENdocardiac Transplantation)
- Conditions
- Acute Myocardial Infarction
- Interventions
- Drug: Standard Treatment for CHF post AMI
- Registration Number
- NCT02669810
- Lead Sponsor
- CellProthera
- Brief Summary
A multicentric controlled phase I / IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process, and injected in patients with an acute myocardial infarction and a LVEF remaining below 50% versus standard of care.
- Detailed Description
The main purpose of this phase I/IIb is to evaluate the safety, the tolerance and the first efficacy trends of intracardiac injection of ProtheraCytes (autologous PB-CD34+ Stem Cells after automated ex-vivo expansion with the StemXpand machine) in patients with an acute myocardial infarction and decreased ejection fraction. ProtheraCytes will be reinjected using a dedicated catheter , thus avoiding open chest surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PROTHERACYTES Standard Treatment for CHF post AMI The interventional investigators will perform the ProtheraCytes® cardiac injections using a catheter introduced via the femoral route up to the left ventricle cavity for intraventricular injections (Helix/Biocardia). Intracoronary injection will be possible with OTW catheter or microcatheter (UK only) if patient presents a contraindication to intramyocardial injection Standard of Care Standard Treatment for CHF post AMI Patients will be treated as standard treatment for CHF post - AMI. PROTHERACYTES PROTHERACYTES The interventional investigators will perform the ProtheraCytes® cardiac injections using a catheter introduced via the femoral route up to the left ventricle cavity for intraventricular injections (Helix/Biocardia). Intracoronary injection will be possible with OTW catheter or microcatheter (UK only) if patient presents a contraindication to intramyocardial injection
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac Events (MACE) From randomization up to 6 months The primary endpoint is the incidence of Major Adverse Cardiac Events (MACE), which have been adjudicated and confirmed to be a MACE by an independent and blinded Clinical Events Committee (CEC) from randomization
- Secondary Outcome Measures
Name Time Method Viability improvement of the infarcted segment(s) From Baseline up to 6 months The viability assessment will be performed using cMRI and perfusion 99mTc SPECT (optional) respectively. A correlation assessment between LVESVi improvement and viability of the infarcted segment(s) will be statistically performed.
Left Ventricle End Systolic Volume index (LVESVi) From Baseline up to 6 months Improvement of LVESVi will be assessed by comparing cMRI at baseline, 3 and 6 months. The left ventricular volumes will be indexed to body surface area. cMRI will also assess other parameters such as:
* Left ventricular end diastolic volume index (ml/m²)
* Left ventricular ejection fraction (%)
* Left ventricular mass (g)Other secondary outcomes measures From Baseline up to 6 months Cardiac event free survival; Quality of life via SF36 scale
Trial Locations
- Locations (13)
CHU BESANCON Hopital Jean Minjoz 3 Boulevard A.Fleming
🇫🇷Besançon, France
Hôpital Haut Levèque
🇫🇷Pessac, France
Ninewells Hospital & Medical School
🇬🇧Dundee, United Kingdom
BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,
🇬🇧Edgbaston, United Kingdom
Saint Bartholomew's Hospital W Smithfield,
🇬🇧London, United Kingdom
GHRMSA
🇫🇷Mulhouse, France
CHU Montpellier Arnaud-De-Villeneuve
🇫🇷Montpellier, France
Institut Jacques Cartier
🇫🇷Massy, France
CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel
🇫🇷Dijon, France
CHU de Grenoble
🇫🇷Grenoble, France
Hôpital de Rangueil
🇫🇷Toulouse, France
Leeds University & Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
University of Edinburgh
🇬🇧Edinburgh, United Kingdom