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Bayer’s BlueRock Therapeutics gains FDA fast track for Parkinson’s disease cell therapy

July 20, 2021


BlueRock – a Bayer subsidiary – is currently evaluating the pluripotent stem cell-derived dopaminergic neuron therapy in a phase 1 study.

This early-stage trial is set to enrol ten patients across the US and Canada, with its primary objective to assess the safety and tolerability of DA01 cell transplantation at one-year post-transplant.

As a secondary objective, BlueRock will assess the evidence of transplanted cell survival and motor effects at one- and two-years post-transplant and evaluate the continued safety and tolerability at two years, as well as the feasibility of transplantation.

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