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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9.0×10^6 cells/person/dose | Experimental | 9.0×10^6 cells/bilateral putamen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XS411CN Cell Injection | Drug | Injection, 5.0×10^6 cells, once, 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Important safety events related to the investigational drug that occur within 28 days after administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael LEE | Contact | +86 21 64027719 | CEO@xellsmart.com |
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