The FDA has granted permission to conduct a study on NouvNeu001, the world's first allogeneic cell therapy based on induced pluripotent stem cells. The drug has been undergoing clinical trials in China since the beginning of 2024.

The Food and Drug Administration (FDA) has approved the study of NouvNeu001, an innovative cell therapy for Parkinson's disease. This news was announced in a press release by iRegene Therapeutics, the company that developed the new treatment method.

NouvNeu001 is claimed to be the world's first allogeneic (i.e., donor-derived) cell therapy based on induced pluripotent stem cells. These cells are artificially created in the laboratory by "reprogramming" ordinary adult cells into embryonic stem cells. Subsequently, they can transform into almost any type of cell in the body.

One of the causes of Parkinson's disease is the death of dopaminergic neurons in a brain region called the substantia nigra. These neurons are responsible for producing dopamine, a neurotransmitter involved in movement control. Symptoms of Parkinson's disease begin to appear when about 50-60% of these cells die.

NouvNeu001 will be administered to patients through stereotactic bilateral intracerebral injection into the striatum or putamen. It is anticipated that the transplanted embryonic stem cells will mature into dopaminergic neurons, establish connections with the remaining neurons in the brain, and restore the production and secretion of dopamine in the affected areas.

Clinical trials of NouvNeu001 began in China at the beginning of 2024. Preliminary results show significant improvement in motor functions in patients with Parkinson's disease without serious side effects.

 

Author: Vladimir Zabolotskikh

Source: Pharmaceutical Bulletin