CellProthera has selected CellforCURE by Seqens as its contract development and manufacturing organization for an upcoming Phase 3 trial of ProtheraCytes, an autologous expanded CD34+ stem cell therapy designed to cut heart failure events after severe myocardial infarction.
Tech transfer will begin this year and the CDMO expects to release the first clinical batches in 2026. The work will be carried out at CellforCURE’s ANSM‑authorized advanced therapy facility, chosen for its infrastructure, late‑stage expertise and track record in commercial autologous cell products.
The partnership covers full GMP qualification of CellProthera’s bioproduction process to ensure the therapy meets release requirements for the pivotal study. ProtheraCytes has completed a Phase 1/2b study that showed encouraging safety and efficacy signals.
Following favorable FDA feedback on its Phase 3 design last year, CellProthera is positioning the therapy for late‑stage evaluation. The product is registered as an advanced therapy medicinal product with the European Medicines Agency and is produced using CellProthera’s automated StemXpand and single‑use StemPack platform.
Sequens Group operates 16 manufacturing sites and nine R&D centers worldwide, giving CellProthera access to large‑scale capacity as it advances towards potential commercialization. For CellforCURE, the agreement broadens its portfolio of cardiovascular regenerative programs and underscores its role in supporting late‑phase cell‐therapy pipelines.