FDA grants fast track designation to stem cell therapy for Parkinson’s disease
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The FDA granted fast track designation to DA01, a stem cell-based therapy, for the treatment of advanced Parkinson’s disease.
DA01 (BlueRock Therapeutics, Bayer) is an allogeneic, gene-edited pluripotent stem cell-derived dopaminergic neuron therapy that is delivered locally through surgical implantation. Preclinical studies have suggested that dopaminergic neurons can restore motor function and increase dopamine release, according to the manufacturer’s website.
FDA fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
“Receiving fast track designation from the FDA is an important step [that] will help us further accelerate clinical development of our DA01 cell therapy approach for Parkinson’s disease,” Joachim Fruebis, PhD, chief development officer with BlueRock, said in a company-issued press release. “This is another critical step in the BlueRock mission to create authentic cellular medicines to reverse devastating diseases, with the vision of improving the human condition.”
Enrollment is underway for a phase 1 trial of DA01 for older patients with advanced Parkinson’s disease.
The study is designed to evaluate the safety and efficacy of DA01 for patients whose current medications are no longer effective and have not received previous neurosurgical treatment for Parkinson’s disease.
The study will enroll 10 patients who will receive gene-edited, dopamine-producing neural cells through surgical implantation into the putamen, which is the area of the brain that controls movement.
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