jct
Open Access
ISSN: 2161-0495
ISSN: 2161-0495
Department of Toxicologic Pathology, Tel Aviv University, Timrat,, Israel
Research Article
Toxicity Studies on Intrathecal Injection of Low Dose of DMSO Used for Cryopreservation of Human Astrocytes in Mice
Author(s): Tehila Sonnenfeld*, Einat Rauchbach*, Rotem Downey*, Daniel Blumenkrants, Arik Hasson, Graciela Kuperstein, Noam Kronfeld, Raanan Margalit, Kfir Molakandov, Vered Morad, Abraham Nyska, Shalom Guy Slutsky, Michel Revel and Michal Izrael*
Background: AstroRx® is an allogeneic cell therapy, composed of healthy and functional human astrocytes derived from pluripotent embryonic stem cells. An intrathecal injection of a fresh formulation of AstroRx® cells for the treatment of Amyotrophic Lateral Sclerosis (ALS) was evaluated in an early-phase I/IIa clinical trial. The results of this study indicated that the treatment is safe and showed a signal of a clinical benefit in attenuating ALS progression. Due to the logistical challenges associated with the manufacturing and distribution of a fresh cell product and to allow completion of safety and quality control testing before cell administration, a cryopreserved formulation of AstroRx® was developed. The cryopreseved AstroRx® product includes 3.5% DMSO as a cryoprotectant. Upon thawing at the clinical.. View More»
DOI:
10.35248/2161-0495.24.13.553