Bayer Advances Parkinson’s Stem Cell Therapy into Phase III Clinical Trial

On September 22, 2025, Reuters reported that Bayer’s subsidiary BlueRock Therapeutics has officially initiated a Phase III clinical trial of its experimental stem cell therapy for Parkinson’s disease. The therapy is based on differentiating human stem cells into dopamine-producing neurons and transplanting them into the brains of patients, aiming to repair neuronal damage and restore motor function.

Early clinical results have shown favorable safety and tolerability. The transplanted cells were able to survive, integrate functionally into the brain, and in some patients demonstrated signs of neurological improvement. The initiation of the Phase III study marks a pivotal step from experimental validation toward potential clinical application, representing a significant milestone in the treatment of neurodegenerative diseases.

Photo by Alejandro Escamilla on Unsplash

To support clinical development and potential commercialization, Bayer is also expanding its cell therapy manufacturing facilities in California. This move underscores the company’s long-term investment in industrializing cell therapies and highlights the strategic importance of cell and gene therapies in the pipelines of major pharmaceutical companies.

Parkinson’s disease is one of the most common neurodegenerative disorders worldwide. Current treatment approaches primarily focus on symptom management and cannot reverse disease progression. Stem cell-based therapies entering late-stage clinical trials are regarded as a transformative opportunity. Should the Phase III trial confirm safety and efficacy, it could open a new therapeutic pathway for millions of patients and accelerate the advancement of the entire stem cell therapy field.

Photo by National Cancer Institute on Unsplash 

With multinational pharmaceutical and biotechnology companies intensifying investment, the industrialization of cell and gene therapies has entered a critical stage. Scalable production capacity, robust process development, and reliable clinical support are becoming decisive factors in bringing these therapies to patients. As part of the industry, Hillgene will continue to closely monitor global progress in cell therapies and support innovation through its CDMO services, helping new therapies transition from research to real-world applications. → Click on me to learn more about Hillgene's CDMO now!

Source: Reuters, “Bayer moves Parkinson’s cell therapy into Phase III trial,” September 22, 2025.