DarwinCell Presents Mesenchymal Stem Cell ALS Therapy at American Neurological Association Meeting

China’s DarwinCell presented new research on its investigational MSC-based therapy, ALT001, for amyotrophic lateral sclerosis (ALS) at the 150th American Neurological Association Annual Meeting (ANA 2025) in Baltimore.

ALS is a progressive neurodegenerative disease marked by muscle weakness, atrophy, and eventual respiratory or circulatory failure. The onset of ALS has been trending younger, with some patients developing symptoms as early as their 20s. In China, the reported incidence is approximately 0.6 per 100,000 people, with a prevalence of 3.1 per 100,000 and an average survival period of three to five years. 

Darwin Cell says that ALT001 has shown encouraging results in both in vitro studies and investigator-initiated trials (IITs) involving more than 40 ALS patients. Key findings presented at the event were:

• In vitro, ALT001-treated cells restored viability following oxidative damage.
• ALT001 protected motoneurons from neurotoxicity and reduced muscle atrophy in SOD1G93A mouse models of ALS.
• Mutant mice treated with ALT001 demonstrated improved motor function and extended lifespan compared to those receiving vehicle or Riluzole.
• Multiple IITs, including a double-blind study, evaluated ALT001’s safety and efficacy in ALS patients. After two weeks of treatment, most patients showed positive outcomes, including improved performance, ALSFRS-R scores (a functional rating scale for ALS), and modified Norris scores (another clinical assessment tool).

“We are greatly honored to share the latest data on ALT001 at this global academic forefront conference,” said Ms. Wang Yu, Founder and CEO of DarwinCell. “These results reinforce our confidence in further developing ALT001 for ALS and other major neurological diseases. ALT001 is designed to combine the functional diversity of cell therapies with the practicality of traditional biologics, aiming to provide patients with more effective, safer, and accessible treatment options. The company remains committed to being clinically-oriented and driven by scientific innovation, continuously deepening our presence in neuroscience and regenerative medicine. Darwin will fully advance the IND application processes for ALT001 in both China and the U.S., hoping to bring new hope to patients worldwide as soon as possible.”

More information can be found at https://darwincell.net/en.

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