CellProthera announced a deal with Shonan Kamakura General Hospital (SKGH) to transfer technology to enable cell therapy manufacturing for clinical trials.
The memorandum of understanding allows for GMP manufacturing of CD34+ endothelial progenitor cells (EPCs) for autologous therapy clinical trials. Takayuki Asahara of SKGH intends to adopt CellProthera’s StemXpand platform for clinical trials starting next year.
StemXpand, an automated, scalable platform expands CD34+ stem cells. It rapidly grows ex vivo a collection of naturally occurring, patient-derived cells into a therapeutic dose. The company reports efficacy across several endpoints in a Phase 2 study of heart failure prevention following acute myocardial infarction. It plans to further use the platform to scale up for a Phase 3 trial.
CellProthera intends to provide StemXpand training to the SKGH team. It expects SKGH to adapt processes to fit with the platform and configure the automated technology to comply with Japanese regulatory requirements.
“This deepening of our relationship with Shonan Kamakura General Hospital marks an important milestone for the global expansion of stem cell-based regenerative medicines,” said Matthieu de Kalbermatten, CEO of CellProthera. “We thank Drs. Kobayashi and Asahara for their confidence in the StemXpand technology, and look forward to further demonstrations of its potential to make CD34+ cell therapies accessible to more patients worldwide.”
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