CellProthera announced it has selected CELLforCURE by SEQENS as its contract development and manufacturing organization (CDMO) partner for the upcoming Phase 3 clinical trial of ProtheraCytes®.
This therapy uses autologous, expanded CD34+ stem cells to potentially improve survival outcomes following severe heart attacks. CellProthera plans to transfer technology to CELLforCURE by SEQENS this year, with the production of clinical batches scheduled to begin in 2026.
According to CellProthera, ProtheraCytes® is a fresh preparation of stem cells that has the potential for regeneration of various damaged tissues, including cardiac tissue.ProtheraCytes® is derived from CD34+ cells harvested from the peripheral blood of the patient after mobilization from the bone marrow, and the proprietary expansion, purification, and formulation in a fresh cell suspension for injection.
Following encouraging results from its Phase 1/2b trial of ProtheraCytes®, CellProthera is currently preparing for the late-stage clinical development. Last year, the company presented its Phase 3 study design to the FDA, receiving positive feedback.
Technology transfer and qualification of the bioproduction process in a specialized facility capable of manufacturing clinical-grade cellular products are necessary steps prior to starting Phase 3. ”Having a partner with expertise in advanced stage of clinical development and commercialization of cell and gene therapies adds substantial value for CellProthera as we enter the final phase of development for ProtheraCytes, looking at Phase 3 and through to market authorization,” said Matthieu De Kalbermatten, CEO of CellProthera.
