FDA backs faster development path for Parkinson’s cell therapy

Sasineprocel gets regenerative medicine advanced therapy designation

Written by Marisa Horak, MS | Aug. 3, 2026

• FDA granted RMAT designation to sasineprocel, a cell therapy for Parkinson's disease.
• This therapy uses engineered stem cells to replace lost dopaminergic neurons.
• Early trial data indicates sasineprocel is safe, improving patient function and quality of life.

The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to sasineprocel (ANPD001), an experimental cell therapy to treat Parkinson’s disease.

The designation, given to promising regenerative therapies (treatments that aim to replace or restore disease-damaged tissue) that could substantially improve care for serious diseases, provides developer Aspen Neuroscience with perks such as more intensive FDA guidance.

“This significant milestone highlights the transformative nature of sasineprocel as a potentially disease-modifying therapy for patients facing a serious disease with substantial unmet medical need,” Damien McDevitt, PhD, president and CEO of Aspen, said in a company press release. “We stand with the Parkinson’s community realizing the urgency around the serious and growing unmet need in [Parkinson’s] and are unwavering in our commitment to bring sasineprocel to patients as soon as possible.”