Regenerative therapy platform to support upcoming clinical trials in Japan

CellProthera, a leader in regenerative therapies for ischemic diseases, has entered into a memorandum of understanding (MOU) with Shonan Kamakura General Hospital (SKGH) to transfer its StemXpand® platform for use in upcoming clinical trials in Japan. The agreement will support Dr Takayuki Asahara and his team as they prepare for autologous CD34+ endothelial progenitor cell (EPC) trials set to begin in 2025.

The StemXpand® platform, already validated in CellProthera's Phase 2 trial, enables the scalable and automated expansion of CD34+ stem cells, helping to generate therapeutic doses for personalized treatments. This technology has shown promising results in heart failure prevention following acute myocardial infarction, and the company plans to scale it for a Phase 3 trial.

The MOU was signed during a visit to CellProthera's headquarters by Shuzo Kobayashi, MD,  PhD, CEO of SKGH, and Dr Asahara, Deputy Director of SKGH's Shonan Research Institute of Innovative Medicine. SKGH will be the first advanced therapy centre in Japan to adopt StemXpand for clinical trials targeting ischemic and renal diseases. CellProthera will assist SKGH in adapting the technology to meet Japanese regulatory standards and provide necessary training for its seamless integration.

SKGH is part of the Tokushukai Medical Group, Japan’s largest healthcare network and the 12th largest globally.

“We see StemXpand as a crucial tool to propel our work forward,” said Dr Kobayashi. “It provides greater robustness than our current systems, while also offering scalability for future trials and commercialization efforts.”

Matthieu de Kalbermatten, CEO of CellProthera, added: “This partnership with SKGH is a significant step in the global growth of stem cell-based regenerative therapies. We are excited to support Drs Kobayashi and Asahara and look forward to seeing the potential of StemXpand in expanding access to CD34+ cell therapies worldwide.”

Both teams are preparing for the shipment of StemXpand and StemPack® equipment to Japan to ensure readiness for the clinical trials in 2025.

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