CellProThera® and BioCardia® today announced an agreement to partner on the EXCELLENT (Expanded Cell Endocardiac Transplantation) Trial, a multi-center, controlled Phase I/IIb study to evaluate the safety and efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process and delivered via the BioCardia HelixT Transendocardial Delivery System.
Background
BioCardia is no stranger to our pages as we’ve followed the progress of its Helix Transendocardial Delivery System. This is a steerable, two-catheter system that enables delivery of biologic therapies to the heart muscle from within the chamber of the heart. The system’s unique performance advantages include crossing the aortic valve over a wire to prevent damage; enhanced navigation using the company’s steerable Morph® guiding catheter; a helical needle which screws into the myocardium for stable delivery; and the use of contrast at the base of the needle to confirm tissue engagement.
French outfit CellProThera is the first company to have conducted successful proof of principle study with autologous CD34+ stem cells to repair myocardial tissue after acute myocardial infarct (AMI). Clinical outcomes have thus far indicated an excellent safety profile, with outstanding clinical benefits. The French pilot study demonstrated both a functional and structural regeneration of the cardiac lesion in patients with AMI after direct intracardiac re-injection of autologous peripheral blood (PB)-CD34+ stem cells.
The trial will study patients with an acute myocardial infarction (AMI) and a left ventricle ejection fraction (LVEF) remaining below or equal to 45 percent after percutaneous transluminal coronary angioplasty (PTCA) and stent(s) implantation versus standard of care. The study will encompass 44 patients treated at up to eight centers in the United Kingdom and France and followed for six months. Co-principal investigators are Jerome Roncalli, MD, PhD, Department of Cardiology, University Hospital of Toulouse, France, and David E. Newby, MD, PhD, University Centre for Cardiovascular Science of Edinburgh, Scotland.
The primary endpoint of the study is no treatment emergent major adverse cardiac events (MACE) at 30 days post-procedure. Secondary endpoints will assess the first efficacy trends, the viability of the infarcted segments, safety of the Helix transendocardial delivery procedure and quality of life.
The agreement between BioCardia and CellProThera calls for milestone payments to BioCardia, which are creditable to a future clinical development program, and milestone payments to CellProThera for timely completion of the Phase II study.
The Helix system has received CE Mark and is commercially available in the European Union. It is currently being used for investigational biotherapeutic programs in the United States and is not approved for sale in the U.S.
Company comments
for CellProThera
“We look forward to taking the next step in demonstrating the safety and efficacy of our promising CD34+ therapy in a Phase II trial,” said CellProThera President and Chief Scientific Officer Philippe Henon, MD. “Partnering with BioCardia, we will be able to safely and effectively deliver our therapy directly to diseased areas of the heart that need it the most, using a system with a safety profile that has been proven in seven clinical trials to date.”
for BioCardia
“The potential of the CD34+ therapy is very exciting and has been demonstrated using surgical intramyocardial delivery,” said BioCardia Chief Executive Officer Peter Altman, PhD. “We look forward to partnering with CellProThera to deliver a procedure proven to be safe in all of our other clinical trials to patients in the EXCELLENT Trial by enabling less invasive, transendocardial delivery using our proprietary Helix technology.”
Source: CellProThera, BioCardia
published: September 18, 2014 in: Cardio, Clinical Studies/Trials