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AstroRx is an allogeneic, "off-the-shelf" cell therapy product composed of healthy and functional human astrocytes derived from human embryonic stem cells (hESCs). Developed by Kadimastem, it is primarily indicated for the treatment of amyotrophic lateral sclerosis (ALS). The therapy is administered via intrathecal injection into the spinal canal, where the healthy astrocytes are intended to compensate for the malfunctioning endogenous astrocytes that contribute to motor neuron death in ALS. AstroRx works through multiple neuroprotective mechanisms, including the clearance of excess glutamate, reduction of oxidative stress, secretion of neurotrophic factors such as GDNF and BDNF, and immunomodulation. Clinical results from a Phase 1/2a trial demonstrated that a single dose was safe and significantly slowed disease progression for three months, supporting the development of Phase 2a trials to evaluate repeated dosing intervals.
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