dm+d

Unassigned

New Medicines

ProtheraCytes Myocardial infarction (MI) in patients with left ventricle ejection fraction below or equal to 45%

Information

ProtheraCytes
New molecular entity
CellProthera
CellProthera

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
None
Apr 20BioCardia reports that it is continuing its clinical work with CellProThera in Singapore and Europe using its Helix delivery catheter to deliver CellProThera ’s CD-34 cells for acute infarction in a clinical trial setting [8].
Apr 19CellProthera has planned a PIII trial, which involves setting up new cell therapy centers in Europe, US and Canada. They are also developing a device which can generate ProtheraCytes on an industrial scale [4].
Jun 13Classified as an advanced therapy medicinal product (tissue engineered product) in the EU [2].

Category

A tissue engineered ATMP. Suspension of expanded CD34+ stem cells conditioned in 3 syringes for an autologous endocardiac injection.
It is estimated that about 103,000 people in the UK have a myocardial infarction each year. About 60% occur in men [1].
Myocardial infarction (MI) in patients with left ventricle ejection fraction below or equal to 45%
Intracardiac

Trial or other data

Nov 20PII EXCELLENT trial entry on the US clinical trials registry has not been updated by CellProthera since Jul 19, and the company website shows no signs of recent activity [6,7].
Dec 19UK trial sites Edinburgh, Leeds [5]
Dec 19NCT02669810 due to complete Dec 20 [5]
Apr 19The procedure requires a simple blood sampling best performed within 2 weeks following a severe AMI. The sampling occurs after a treatment period using GCSF in order to mobilize the patient’s own stem cells into the blood flow. The blood sample is then forwarded to a local certified Cell Therapy center and processed in a proprietary automated device StemXpand® using a standard kit StemPack® for the preparation of the final graft product ProtheraCytes®. When injected into scar tissue within the heart wall, CD34+ cells have experimentally shown in nude mice the capability to engraft in the damaged tissue and to differentiate into mature myocardial and endothelial cells [1].
Nov 17PII EXCELLENT study is recruiting [3].
Sep 15PII EXCELLENT study 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 a de novo acute myocardial infarction and decreased ejection fraction (NCT02669810). 44 adults will be recruited in France and the UK (at the University of Edinburgh or the Leeds University & Leeds Teaching Hospitals NHS Trust). The investigators will perform the ProtheraCytes® endocardiac injections using the HELIX® catheter introduced via the femoral route up to the left ventricle cavity. Primary outcome is proportion of adverse events (including MACE), until 6 months. Secondary outcome is improvement of the left ventricle end systolic volume index, assessed by cMRI. Collection of primary outcome data is due to complete Dec 18 [3].