A Phase I Study to Assess the Safety, Tolerability and Efficacy of dopaminergic neural progenitor cells (XS411CN cell injection) for the treatment of multiple system atrophy Parkinsonian variant (MSA-P).
Male or female, aged 30 to 75;
According to the 2022 International Movement Disorders Association's Diagnostic Criteria for Multiple System Atrophy, the patient meets the clinically confirmed and clinically probable diagnostic criteria for multiple system atrophy, and is diagnosed with Parkinson's type multiple system atrophy.
MSA movement disorder symptoms have been present for no more than 5 years;
The participant or their legal guardian must agree to the research protocol and sign a written informed consent form.
Patients diagnosed with primary Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, corticobasal degeneration, secondary Parkinsonian syndrome (cerebrovascular, drug-induced, traumatic, encephalitis), essential tremor, or other serious neurological diseases.
Patients who have any impact or contraindications on any research procedure, including but not limited to: contraindications to general anesthesia or stereotactic surgery (such as sleep apnea, chronic obstructive pulmonary disease, etc.), contraindications to cranial MRI/PET examination, cranial CT/MRI showing severe brain atrophy, space-occupying lesions (such as brain tumors), hydrocephalus, cerebral vascular malformations, or structural abnormalities that researchers judge to affect transplantation or increase surgical risk.
Patients diagnosed with primary Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, corticobasal degeneration, secondary Parkinsonian syndrome (cerebrovascular, drug-induced, traumatic, encephalitis), essential tremor, or other serious neurological diseases.
Patients who have any impact or contraindications on any research procedure, including but not limited to: contraindications to general anesthesia or stereotactic surgery (such as sleep apnea, chronic obstructive pulmonary disease, etc.), contraindications to cranial MRI/PET examination, cranial CT/MRI showing severe brain atrophy, space-occupying lesions (such as brain tumors), hydrocephalus, cerebral vascular malformations, or structural abnormalities that researchers judge to affect transplantation or increase surgical risk.
Single group
XS411CN Cell Injection
DrugInjection, 5.0×10\^6 cells, once, 12 months
To evaluate the safety and tolerability of stereotactic intracerebral transplantation of XS411CN cells for the treatment of MSA-P.
Definition of important safety events: Any adverse event of grade 3 or higher that is related to the investigational drug (including definitely related, very likely related, and possibly related) and occurs within 28 days after administration of the investigational drug (graded according to the National Cancer Institute (NCI) Common Adverse Event Evaluation Criteria (CTCAE) version 6.0).
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This trial is not recruiting at the moment. You can still explore other options:
