Highlight
The Phase 1 study of allogeneic regulatory T-cell (Treg) therapy in Amyotrophic Lateral Sclerosis (ALS) yielded several critical findings for the field of neuroimmunology:
- Zero dose-limiting toxicities: The use of off-the-shelf, non-HLA-matched umbilical cord blood Tregs was well-tolerated without the need for lymphodepletion or immunosuppression.
- Significant functional stabilization: In participants with complete data, the rate of functional decline (ALSFRS-R) slowed from -1.66 points/month pre-treatment to -0.41 points/month during the treatment phase.
- Scalable therapeutic model: Unlike previous autologous Treg trials, this allogeneic approach offers a viable path for large-scale clinical application.
