US, China regulators OK trials of stem cell therapy in MSA-P
Xellsmart says Phase 1/2 clinical testing to begin this year
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- Regulators cleared trials for Xellsmart's stem cell therapy for MSA-P.
- MSA-P is a rare neurodegenerative disorder that lacks effective treatments.
- The therapy uses neuron progenitor cells to replace damaged brain cells.
Regulators in the U.S. and China have granted Xellsmart permission to start clinical testing of its experimental stem cell therapy in people with multiple system atrophy-Parkinsonian type (MSA-P).
This is the fourth clinical trial program for Xellsmart’s stem cell therapy platform to have received regulatory clearance from both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA), according to a company press release, The company has secured approvals for trials testing its approach in people with Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and spinal cord injury.
Xellsmart expects Phase 1/2 clinical trials for MSA-P in China and the U.S. to begin in 2026.
Stem cells are primordial cells that can grow and differentiate into other cell types. Xellsmart’s therapy uses specially engineered neuron progenitor cells, which are stem cells that can develop into nerve cells and other types of brain cells.
Rare disorder lacks treatment options
Parkinson’s disease is caused by the death and degeneration of dopaminergic neurons, the nerve cells that produce the chemical messenger dopamine. Xellsmart’s approach aims to use stem cells to replace the lost nerve cells, thereby slowing disease progression.
MSA-P is a rare form of atypical parkinsonism. It’s characterized by Parkinson’s-like motor symptoms such as slowed movement and rigidity, but patients also typically experience dysregulation of the autonomic nervous system (the part of the nervous system that regulates unconscious bodily processes like breathing and blood pressure).
Parkinson’s treatments can help ease some symptoms of MSA-P, but they generally prove less beneficial in MSA-P than in Parkinson’s itself.
As with Parkinson’s, no approved therapies have been proven to slow MSA-P progression. And like Parkinson’s, MSA-P is marked by the degeneration and death of certain brain cells. Xellsmart’s stem cell therapy aims to replace these damaged cells.
Xellsmart said the move into MSA-P also relies on positive results from Parkinson’s trials that have enrolled more than 12 patients. Early findings indicate that the therapeutic stem cells survive and grow into mature nerve cells after implantation in the brain. The company also said there have been no unexpected safety findings so far, and that measures of Parkinson’s symptom severity have shown generally positive trends.
