UniXell Biotechnology Announces First Patient Treated with UX-DA001 in Phase 1 Parkinson’s Disease Trial

Shanghai UniXell Biotechnology Co., Ltd., a company focused on developing innovative cell therapies, has announced the successful first administration of its experimental cell therapy drug, UX-DA001, for people living with Parkinson’s disease. This milestone marks the beginning of China’s first clinical trial using a personalized, stem cell-based treatment derived from a patient’s own cells. First Patient Shows Encouraging Early Results On March 1, 2025, a surgical team at Ruijin Hospital in Shanghai, led by Dr. Li Dianyou, performed the procedure to transplant the treatment into the brain of the first participant. One month after surgery, the individual reported improvements in motor function and sleep quality, with no serious side effects. The patient shared: "After receiving the stem cell treatment, I experienced a remarkable improvement in my sleep quality. I fall asleep quickly and notice gradual progress every day. Although recovery takes time, the 'day by day improvement' fills me with hope for the future." Why Cell Therapy Matters for Parkinson’s According to Dr. Liu Jun, the trial's Principal Investigator and Director of Neurology at Ruijin Hospital, current treatments for Parkinson’s disease are typically based on medications that manage symptoms. However, over time, these drugs can become less effective and may not slow disease progression. Cell therapy, by contrast, offers the potential for a "one-time treatment with long-term benefits" by replacing lost dopamine-producing neurons rather than only treating symptoms. What Is UX-DA001? UX-DA001 is a first-of-its-kind therapy in China that uses induced pluripotent stem cells (iPSCs). These cells are created by reprogramming a patient’s own blood cells and turning them into dopaminergic neurons—the type of brain cell that Parkinson’s disease affects most. These lab-grown neurons are then carefully transplanted back into the brain using minimally invasive surgery. Because the cells originate from the patient’s own body, there is a low risk of immune rejection, and patients do not need immunosuppressive drugs, which often carry significant side effects. Global Regulatory Support and Future Potential UX-DA001 received approval to begin clinical trials from both the National Medical Products Administration (NMPA) of China and the U.S. Food and Drug Administration (FDA) in late 2024 and early 2025, respectively. These approvals signal growing global interest in this innovative approach to treating Parkinson’s. The ongoing Phase I trial at Ruijin Hospital focuses on evaluating the safety, tolerability, and early signs of benefit of the treatment. Researchers will also assess whether the transplanted cells survive, integrate, and improve movement and quality of life for participants.