UniXell Biotech Initiates China’s First iPSC-Based Cell Therapy Trial for Parkinson’s Disease

26 May 2025 | Monday | News


Successful first administration of UX-DA001 marks a milestone in autologous iPSC-derived treatments, showing early signs of improved motor and sleep functions
Image Source : Public Domain

Image Source : Public Domain

Shanghai UniXell Biotechnology Co., Ltd. (UniXell Biotech), a biotech company dedicated to innovative cell therapies, announced the successful first administration of its proprietary Parkinson's disease cell drug UX-DA001 in China in March 2025. The Phase I clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of UX-DA001 in patients with Parkinson's disease.

On March 1, 2025, Dr. Li Dianyou, Director of the Functional Neurosurgery Department at Ruijin Hospital, performed the surgical path planning and the subsequent stereotactic surgery for transplantation. The successful surgery marks the official initiation of China's first registration-directed clinical trial for an autologous iPSC-derived cell therapy for Parkinson's disease.

The one-month postoperative follow-up revealed significant improvements in the patient's sleep quality and motor function, with no severe adverse events reported. The first recipient of UniXell's autologous stem cell-derived drug, UX-DA001, 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."

Dr. Liu Jun, Principal Investigator of the trial and Director of the Neurology Department at Ruijin Hospital, noted "current standard treatment for Parkinson's disease primarily relies on medications to alleviate symptoms. However, after prolonged oral drug treatment, patients often experience fluctuations in efficacy and disease progression continues. In contrast, cell therapy offers the prospect of 'one-time treatment with long-term benefits.'"

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