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Aspen Neuroscience Gets FDA Permission to Start Autologous Cell Therapy Trial in Parkinson's Disease

NEW YORK – Aspen Neuroscience on Tuesday said the US Food and Drug Administration cleared its investigational new drug (IND) application seeking permission to begin clinical trials of the autologous cell therapy ANPD001 in Parkinson's disease.

San Diego-based Aspen Neuroscience will proceed with a first-in-patient Phase I/IIa clinical trial testing ANPD001 in patients with moderate-to-severe Parkinson's, a neurodegenerative disease caused by loss of dopamine neurons in the brain. Investigators will assess the safety, tolerability, and preliminary efficacy of the drug in the single-arm, open-label, dose-escalation trial.

The treatment involves taking a sample of patients' own skin cells and reprogramming them into induced pluripotent stem cells (iPSCs). From these iPSCs, the firm manufactures dopamine-producing neuronal precursor cells. Aspen Neuroscience then evaluates the cells for activity and quality with its genomic assays before administering them back to the patient through a surgical procedure to replace cells that were lost or damaged due to disease.

"The IND clearance of ANPD001 sets in motion a path toward a new treatment for the more than 1 million Americans and 10 million people worldwide with Parkinson's disease," Aspen Neuroscience President and CEO Damien McDevitt said in a statement.