BlueRock Therapeutics secures FDA fast track for Parkinson’s disease cell therapy
BlueRock, a Bayer subsidiary, is currently assessing the pluripotent stem cell-derived dopaminergic neuron therapy in a phase 1 study.
This early-stage trial is set to enroll ten patients across the US and Canada, with its primary aim to evaluate the safety and tolerability of DA01 cell transplantation at one year post-transplant.
As a secondary aim, BlueRock will evaluate the evidence of transplanted cell survival and motor effects at one- and two years post-transplant and assess the continued safety and tolerability at two years, as well as the feasibility of transplantation.
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