Kadimastem, an Israeli biotechnology company, will be conducting a Phase I/IIA clinical trial with its stem cell product, AstroRx®, derived from Hadassah’s clinical grade human embryonic stem cell (hESC) lines.
The trial, whose protocol was designed with Hadassah, is scheduled to begin at the hospital toward the end of 2017, with the exact time frame depending on completion of the pre-clinical safety studies and necessary ethical approval.
The trial will include 21 patients and be conducted by Hadassah’s Department of Neurology, under the direction of Prof. Tamir Ben-Hur. AstroRx® is a cell-based treatment based on astrocytes (nervous system tissue cells) produced from stem cells. According to Kadimastem,”its unique technology allows for large-scale production of the cells according to Good Manufacturing Practices (GMP) standards.” The astrocytes, Kadimastem reports, have the potential to be used as an off-the-shelf product for the treatment of large patient populations worldwide.
The administering of AstroRx® to the cohort will be performed by means of a standard injection directly into the spinal fluid, which is effective in dispersing the cells throughout the central nervous system. The injection of healthy, functioning astrocytes into the nervous system of ALS patients is expected to provide systemic support for the damaged motor neurons, thereby inhibiting disease progression and improving the patients' life expectancy and quality of life. The starting material from which the Company produced its product, is a line of unique human embryonic stem cells, developed in the laboratory of Prof. Benjamin Reubinoff, Director of Hadassah’s Human Embryonic Stem Cell Center, without the use of materials derived from animals. The cells were received under a licensing agreement with Hadasit, Hadassah’s technology transfer company. Prof. Reubinoff and Prof. Ben-Hur are members of Kadima’s Scientific Advisory Board.
Prof. Michel Revel, the company's Chief Scientist, notes: "This is a very significant step in the development of Kadimastem's product for the treatment of ALS. We are happy about the collaboration with the distinguished Hadassah Medical Center and, in particular, with Prof. Tamir Ben Hur, head of the Neurology Department and Dr. Marc Gotkine, director of the ALS clinic."
Dr. Tamar Raz, Chief Executive Officer of Hadasit, adds: "We are proud that the starting material, which originated in Hadassah Hospital, has been developed and matured to a clinical trial product by Kadimastem, a company with which we have excellent cooperation. The ALS clinic in Hadassah in which the trial will be conducted is a global leader, and is experienced in recruiting patients for cell therapy."