A Clinical Trial of Parkinson's Disease Treatment by hiPSCs Derived Dopaminergic Neural Precursor Cells

1.Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest(AESI)

XellSmart Biomedical (Suzhou) Co., Ltd. has closely collaborated with Shanghai East
 Hospital(East Hospital Affiliated To Tongji University) , using iPSC seed cells, on the
 development and establishment of a dopaminergic neural precursor cell production system.
 These iPSC seed cells are sourced from the National Stem Cell Translational Resource Bank in
 Shanghai East Hospital (East Hospital Affiliated To Tongji University), and the construction
 of the cell bank is carried out by Shanghai East Hospital. The iPSC seed cell preparation
 method and testing standards have been certified by National Institutes for Food and Drug
 Control in China.
 
 This study is conducted under collaboration between Shanghai East Hospital and XellSmart
 Biomedical (Suzhou) Co., Ltd. It is a distinctive stem cell therapy research targeting
 Parkinson's disease patients, characterized by the following:
 
 1. The first instance in China of using autologous iPSC-derived subtype-specific
 dopaminergic neural precursor cells for alternative transplantation therapy in
 Parkinson's disease.
 
 2. Before the initiation of this study, there was only one reported case around the world
 involving the use of laboratory-grade autologous iPSC-induced dopaminergic neural
 precursor cells for Parkinson's disease treatment in an American Caucasian individual.
 Positive preliminary clinical research results were obtained and published in the New
 England Journal of Medicine in 2020. Since then, no similar studies have been reported.
 
 It has great significance to conduct this research. It will fill two critical clinical
 research gaps in stem cell therapy for Parkinson's disease in the world:
 
 1. The use of clinical-grade autologous iPSCs differentiated into dopaminergic neural
 cells, and treat Parkinson's disease.
 
 2. Evaluating the safety of using autologous iPSC-differentiated dopaminergic neural cells
 for Parkinson's disease treatment in individuals of Asian descent or Chinese ethnicity.