Overview
CellProthera develops ProtheraCytes, an autologous CD34+ stem cell therapy registered as an Advanced Therapy Medicinal Product (ATMP) by the EMA, for regenerating damaged cardiac tissue post-acute myocardial infarction (AMI). The therapy uses a GMP-compliant expansion process with the proprietary StemXpand automated device and StemPack kit to produce large quantities of purified stem cells from patient peripheral blood. The company is advancing Phase III trials in the US, Europe, and potentially Asia, partnering with CDMOs like CELLforCURE by SEQENS for manufacturing.
Frequently asked questions
- What is ProtheraCytes and its regulatory status?
- ProtheraCytes is an autologous CD34+ stem cell therapy for tissue regeneration, particularly cardiac tissue post-AMI. It is registered as an Advanced Therapy Medicinal Product (ATMP) in the Tissue Engineered product category by the European Medicines Agency (EMA).
- What manufacturing technology does CellProthera use?
- CellProthera employs a GMP-compliant cell expansion process with the StemXpand automated device and StemPack disposable kit for in vitro production of large quantities of purified CD34+ stem cells from mobilized peripheral blood.
- What is the clinical trial status and geographic scope?
- CellProthera completed successful Phase II trials and plans a Phase III study starting Q1 2027, enrolling 300-400 patients at ~50 sites in the US and Europe, with potential Asian sites. Partnerships include BioCardia and a transendocardial catheter from Celyad Oncology.