ALS Community Tells FDA ‘We Have No Time To Waste’; Urges Changes in Trial Design and Review Process

Because of the relentless effects of ALS, a diverse group of ALS voices — patients, families, organizations and the community — came together to speak about their experiences with ALS and to urge the FDA to work with them to overcome some of the obstacles faced in ALS research, clinical trials and standards of care.

Regulatory Cells Associated with Speed of ALS Progression

“These results support the importance of the immune system, and more specifically T-reg populations, in modulating the clinical course of a patient’s disease,” Appel said. “Thus, enhancing the number of T-regs and their anti-inflammatory functions in ALS patients could have important therapeutic benefits in slowing the rate of disease progression and stabilizing ALS patients for longer periods of time than currently available therapies.”