Israeli Placenta-Based Cell Therapy Company Granted US Patent for Skeletal Muscle Regeneration

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products based in Haifa, Israel, announced last week that the US Patent and Trademark Office had issued it a patent titled, “Skeletal muscle regeneration using mesenchymal system cells.”

Mesenchymal stromal cells are spindle-shaped plastic-adherent cells isolated from bone marrow (BM), adipose tissue and other organs, including the placenta.

This key patent, which has already been granted the company in Europe, Hong Kong and Israel, addresses the use of MSCs for skeletal muscle regeneration used either directly after, or shortly after, post-surgical muscle injury.

Pluristem Therapeutics received positive feedback from the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA) for the proposed study design and endpoints of its Phase III trial for the treatment of muscle recovery following arthroplasty (an orthopedic surgical procedure where the articular surface of a musculoskeletal joint is replaced, remodeled, or realigned) for hip fracture. This planned study was recently awarded an $8.7 million grant by Horizon 2020, the European Union’s largest research and innovation program. If successful, Pluristem plans to use the study results to achieve marketing approval in both the US and Europe.

Previous clinical studies using PLX-PAD (PLacental eXpanded) cells demonstrated significant muscle regeneration following arthroplasty, including a 300% improvement in muscle volume and a 500% boost in muscle force when observed six months after surgery compared to the control group.

“This very important patent comes at the right time, just ahead of our planned Phase III study in muscle regeneration following hip fracture,” stated Zami Aberman, Chairman and Co-CEO of Pluristem. “The patent substantially strengthens our intellectual property around muscle regeneration, particularly as it pertains to repair and regeneration following surgery. In an industry that demands constant technological and scientific advances, a robust patent portfolio covering our core innovations strengthens Pluristem’s competitive edge.”