This Phase I clinical trial is designed to evaluate the safety, tolerability of a single dose of XS411 (derived dopaminergic neural progenitor cell injection) in patients with primary Parkinson's disease
Male or female, aged between 50 and 75 years old;
Diagnosed as 'clinically established PD' consistent with MDS clinical Diagnostic Criteria for Parkinson's disease,
A minimum of 5 years since diagnosis;
Hoehn- Yahr score during the off-time is 3 to 4;
Parkinsonian syndrome or secondary Parkinson's disease (Atypical Parkinson's syndrome (Parkinson's plus syndrome, secondary Parkinson's syndrome, hereditary degenerative Parkinson's syndrome);
Patients are in advanced stages of Parkinson's disease and are experiencing severe, disabling peak-dose dyskinesia or biphasic dyskinesia and/or unpredictable or widely fluctuating symptoms;
Severe cognitive impairment (MMSE<24, poor compliance due to dementia, inability to accurately record diaries, and/or inability to sign informed consent;
Those with a history of severe mental illness, or those with severe suicidal tendencies as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS), or those with suicidal ideation in the past 12 months, or those who have attempted suicide in the past 5 years;
Sequential
human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection
Drug5.0×10\^7 cells/mL, injection, once, 12 months
To evaluate the safety and tolerability of XS411CN in treatment of primary Parkinson's disease
To evaluate the safety and tolerability of XS411CN in treatment of primary Parkinson's disease through: 1）The occurrence and incidence of adverse events and serious adverse events (adverse event grading criteria are based on NCI-CTCAE V5.0) 28 days after administration of XS411CN; 2) Changes in vital signs, laboratory tests, 12-lead electrocardiogram, etc. compared with baseline after administration of XS411CN;
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XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
Lead sponsor
Beijing Tiantan Hospital
Collaborator
