Novel Cell Therapy Cleared by FDA for Investigation as Potential Treatment for Parkinson Disease

The Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for NouvNeu001 (iRegene, Wuhan, China), a novel cell therapy for the treatment of Parkinson disease (PD). According to a statement from iRegene, NouvNeu001 is the world’s first induced pluripotent stem cell (iPSC) and chemically induced allogenic cell therapy product to enter clinical stages for PD treatment. The clearance follows the FDA’s granting of special exemption status to NouvNeu001 in March 2024 based on the product’s development platform.

Clinical trials were initiated in China at Beijing Hospital and Zhongnan Hospital of Wuhan University in the beginning of 2024 to assess the safety, tolerability, and efficacy of NouvNeu001 for stereotactic intracerebral bilateral injection for people with mid-to-late-stage PD. According to iRegene’s statement, preliminary results suggest that people receiving treatment with NouvNeu001 demonstrated improvements in motor function with no treatment-related adverse events.

"On the basis of cautious and robust R&D efforts, iRegene aims to leverage its innovative technologies to bring breakthroughs for a multitude of currently incurable diseases, bringing hope to patients and families deeply affected by these conditions,” said Dr. Wei Jun, CEO of iRegene. “Dual approval of IND applications of NouvNeu001 by the U.S. FDA and China NMPA further boosts the confidence of iRegene's global team in building a world-class innovative platform.”