Steminent to Showcase Breakthrough MSC-based Therapy for Spinocerebellar Ataxia at WODC USA and ISCT 2025

BOSTON, April 24, 2025 /PRNewswire/ -- Founded in 2007, Steminent Biotherapeutics Inc. is set to present Stemchymal^®, its lead investigational therapy, at the World Orphan Drug Congress (WODC) USA 2025 on April 23 in Boston and the ISCT 2025 Annual Meeting in New Orleans in May. These international debuts mark a milestone for the company as it prepares to bring its proprietary stem cell therapy to global attention.

Stemchymal^® is an allogeneic adipose-derived mesenchymal stem cell (MSC) therapy developed for spinocerebellar ataxia (SCA), a rare neurodegenerative disease that is currently incurable. Administered intravenously, the off-the-shelf product provides neuroprotective effects and alleviates the accumulation of neurotoxic proteins that cause SCA3, the most prevalent subtype of the progressive disease in Taiwan.

Unlike conventional approaches that merely relieve symptoms, Stemchymal^® tackles the root cause of SCA3 by inducing cellular autophagy that degrades mutant Ataxin-3, the major pathological driver of disease progression. This unique mechanism, backed by U.S.-granted patent protection, sets the therapy apart and makes it a first-in-class candidate for PolyQ protein-related disorders, including SCA3 and Huntington's disease.

At WODC USA 2025, Steminent debuted the Phase 2 data from Taiwan, where patients with moderate-to-severe SCA3 received three doses of Stemchymal^® over 12 months. Statistically significant disease stabilization was observed based on both the SARA and fSARA scores, with some patients showing meaningful clinical improvement. The findings were in contrast with the expected annual deterioration seen in both placebo-controlled and natural history cohorts, supporting the product's disease-modifying potential. These results are echoed in another multi-center Phase 2 trial in Japan involving SCA3 and SCA6 patients, underscoring the therapy's efficacy in different populations. Stemchymal^® shows competitive therapeutic effects on SCA treatment in global drug development. 

In early May, at ISCT 2025, Dr. Susan Perlman, professor of neurology at UCLA and the company's clinical advisor, will present a U.S.-based late-breaking case report, further validating Stemchymal^®'s safety and feasibility in clinical use.

Steminent is currently the only Asian company recognized by Japan's MHLW as an "Accredited Foreign Manufacturer" of regenerative medical products. Its facility integrates a customized cell processing isolator for GMP-compliant, scalable and export-ready production. With regional licensing agreements in Japan and Korea, and global partnership discussions ongoing, the Taiwan-based stem cell innovator is targeting conditional approvals in Taiwan and Japan and FDA clearance for a U.S. Phase 2b trial in 2025, positioning itself as a rising force in the global advanced therapy ecosystem.

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SOURCE Steminent Biotherapeutics