Revolutionizing ALS Treatment: BrainStorm’s Phase 3b Trial Moves Forward with FDA Approval
BrainStorm Cell Therapeutics Inc., a leader in adult stem cell therapeutics for neurodegenerative diseases, has achieved a significant milestone with the FDA’s agreement on a Special Protocol Assessment (SPA) for its Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). This agreement marks a critical step in advancing the potential treatment to the market, […]
BrainStorm Cell Therapeutics Announces Key FDA Meeting for ALS Treatment
BrainStorm Cell Therapeutics Inc., a prominent developer of adult stem cell therapies for neurodegenerative diseases, has announced a significant development in their pursuit of treating amyotrophic lateral sclerosis (ALS). The company has secured an in-person meeting with the U.S. Food & Drug Administration (FDA), scheduled for December 6, 2023. This meeting is a critical step […]
Regenerative Medicine: Induced Pluripotent Stem Cells (iPSCs) Therapy in Neurological Disorder Treatment
In recent years, the scientific community has been abuzz with the potential of induced pluripotent stem cells (iPSCs) for treating a myriad of diseases, especially neurological disorders. The allure of iPSCs lies in their ability to morph into any cell type in the human body, a characteristic termed as pluripotency. This remarkable trait is achieved […]
I Am ALS and Veterans with ALS send an Open Letter to FDA Requesting an Advisory Committee Meeting to Discuss NurOwn
WASHINGTON, Nov. 23, 2022 /PRNewswire/ — To the Honorable Dr. Robert Califf and Dr. Peter Marks: We represent Veterans with ALS who support Brainstorm Cell Therapeutics’ request for the FDA to hold a public Advisory Committee meeting (“AdCom”) to engage in scientific discourse about the “clinically meaningful” evidence supporting FDA’s approval of a mesenchymal stem cell therapy, NurOwn. When we […]