Phase I/IIa Clinical Trial of Stem Cell Therapy for Amyotrophic Lateral Sclerosis Begins in Israel
Approval has been granted by the Israel Ministry of Health’s Supreme Committee for Kadimastem (NessZiona, Israel) to immediately begin a phase I/IIa clinical trial of their stem cell therapy to treat patients with amyotrophic lateral sclerosis (ALS). The trial will be conducted at the Hadassah Ein-Kerem Medical Center’s Department of Neurology and is expected to enroll 21 subjects with ALS. Recruitment will start immediately, and the investigators hope to begin treatments within 2 weeks. The trial will be performed within US Food and Drug Administration’s (FDA’s) guidelines and coordinated with that agency.
The treatment being tested is AstroRx, a cell-based treatment for ALS developed as part of Kadimastem’s unique technological platform for the repair and replacement of tissue and organs, using functioning cells differentiated from pluripotent stem cells. Astrocytes developed on the platform that have shown high efficacy in protecting the survivability and functioning of motor neurons in ALS models, will be administered to patients via injection into the cerebrospinal fluid. It is hoped that the injection will replace astrocytes, slow disease progression, improve quality of life, and prolong survival.
Yossi Ben-Yossef, CEO of Kadimastem, noted: "The vision before us, when Professor Revel and I founded the company, was to build a leading company in the cell-therapy field, and to develop innovative, groundbreaking treatments to help millions of patients suffering from various diseases worldwide. Today, we are proud to announce the start of this vision turning into reality, with the receipt of the Ministry of Health's approval for commencing our clinical trial in ALS. The commencement of the clinical trial is the most significant event since the founding of the company."
Professor Michel Revel, the company's Chief Scientist, said: "I am very happy the company had achieved this important milestone and received approval for the clinical trial in ALS patients . . . We see in this cell-based product high hopes for effective treatment of ALS.”
Professor Tamir Ben-Hur, Head of the Department of Neurology in Hadassah Medical Center in Jerusalem, added: "We are happy to be commencing the first-of-its-kind clinical trial using human embryonic stem cells for the treatment of ALS, an incurable neurodegenerative disease.”