13 Dec CellProthera Signs MOU with Shonan Kamakura General Hospital for Use of StemXpand® in Japanese Stem Cell Clinical Trial
CellProthera will carry out technology transfer ahead of autologous CD34+ endothelial progenitor cell clinical trials planned by Dr. Takayuki Asahara and his team in 2025.
Mulhouse, France, December 12, 2024 – CellProthera, a regenerative cell therapy developer specializing in ischemic diseases, announced a new memorandum of understanding with Shonan Kamakura General Hospital (SKGH) to transfer technology that will enable GMP manufacturing of CD34+ endothelial progenitor cells (EPCs) for autologous therapy clinical trials. CellProthera’s StemXpand® platform, which the company has validated in its own Phase 2 therapeutic trial, will be adopted by world-renowned stem cell expert Takayuki Asahara, M.D., Ph.D. for clinical trials at SKGH starting in 2025.
StemXpand is an automated, scalable platform to expand CD34+ stem cells, which CellProthera has used in its recently completed Phase 2 clinical trial. The technology rapidly grows ex vivo a collection of naturally occurring, patient-derived cells into a therapeutic dose that has demonstrated efficacy across several endpoints in a Phase 2 study of heart failure prevention following acute myocardial infarction. The company further intends to use StemXpand as it scales up for a forthcoming Phase 3 trial.
The new memorandum of understanding was signed during a visit to CellProthera’s corporate headquarters by Shuzo Kobayashi, M.D., Ph.D., CEO of SKGH and Dr. Asahara, who is Deputy Director of SKGH’s Shonan Research Institute of Innovative Medicine. The SKGH team will be the first advanced therapy developers in Japan to utilize the latest version of StemXpand, for a clinical trial using CD34+ EPCs in patients with ischemic and renal diseases. CellProthera will provide training to the SKGH team as it adapts processes to fit with StemXpand, and configure the automated technology to be compliant with Japanese regulatory requirements.
SKGH is part of the Tokushukai Medical Group, Japan’s largest medical services group and the 12th largest in the world.
“StemXpand will be an invaluable enabling technology to advance our work,” said Dr. Kobayashi. “It is a more robust platform than our current technology that is both better adapted to our current needs and scalable for potential larger trials and commercialization in the future.”
“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.”
The partners are preparing to transfer StemXpand and StemPack® equipment to Japan for on-site qualification and configuration ahead of clinical trials next year.
About CellProthera
CellProthera is a regenerative cell therapy developer specializing in cardiovascular diseases with a leading program in myocardial infarction. CellProthera has developed a unique GMP-compliant cell expansion process as well as a proprietary automation technology for in vitro production of a large quantity of purified, CD34+ stem cells. Its lead therapy ProtheraCytes®, is an autologous cell therapy developed for body regeneration and targeted to regenerate various damaged tissues, including cardiac tissue. ProtheraCytes is registered as an Advanced Therapy Medicinal Product – ATMP – by the European Medicines Agency (EMA). CellProthera’s proprietary technology platform comprises an automated expansion device called StemXpand® and its single use kit StemPack®. CellProthera is headquartered in France.