XellSmart Pharmaceutical Co., Ltd has secured its fourth consecutive Investigational New Drug (IND) clearance from both the US Food and Drug Administration and China’s National Medical Products Administration for a Phase I/II clinical trial of its allogeneic, off-the-shelf, iPSC-derived neuron progenitor cell therapy targeting multiple system atrophy-Parkinsonian type (MSA-P), according to company announcements and industry coverage.
The latest clearances extend XellSmart’s regulatory progress in the central nervous system (CNS) therapy space following three prior IND approvals for its iPSC-derived cell therapies in Parkinson’s disease, spinal cord injury and amyotrophic lateral sclerosis. The MSA-P therapy is being positioned as a potential regenerative option for a rare, rapidly progressive neurodegenerative disorder with limited effective treatments, the company states.
XellSmart says the IND approvals reflect its clinical and manufacturing capabilities in developing universal iPSC-derived cell therapies and underscore its commitment to addressing unmet needs in serious CNS diseases. The company’s portfolio now includes multiple products progressing toward or already in early clinical evaluation across neurodegenerative indications, with the MSA-P programme expected to begin trials in 2026.
MSA-P is characterised by progressive motor symptoms and autonomic dysfunction, and there are currently no approved therapies that effectively slow disease progression. XellSmart’s approach aims to explore regenerative mechanisms, such as promoting dopamine secretion and neural circuit repair, as part of its therapeutic strategy for this rare condition.
The consecutive clearances in both the US and China mark a notable regulatory milestone for XellSmart’s pipeline, supporting its broader efforts to advance iPSC-based regenerative treatments for neurological disorders.
