General Information |
| Summary |
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 |
| Description |
This is a phase I clinical study to evaluate the safety and tolerability of human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection (XS411CN) via brain stereotactic transplantation for the treatment of primary Parkinson's disease.
The study adopts a single-arm, open-label, non-randomized dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of stereotactic brain transplantation of XS411CN in patients with primary Parkinson's disease and explore the optimal recommended dose. 12 to 18 patients with primary Parkinson's disease are planned to be enrolled.
On the day of cell transplantation surgery, the planned dose of XS411CN is transplanted into the bilateral putamen of the subjects by brain stereotactic technology.
After receiving the XS411CN transplantation, the subjects will receive immunosuppressants. All subjects receive standard treatment at the same time.
Each patient receives a safety observation period of 28 days after cell transplantation with XS411CN. This study adopts the traditional "3+3 " dose escalation method. The trial starts with a low dose and the dose will be increased gradually. Each subject will be closely observed for 7 days after surgery, and the dose-limiting toxicity (DLT) events that may occur within 28 days after the first transplant treatment will be evaluated. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2025-08-05 |
| End date (estimated) |
2029-08-30 |
| Clinical feature |
| Label |
Parkinson's disease |
| Link |
http://purl.obolibrary.org/obo/DOID_14330 |
| Description |
A synucleinopathy that has_material_basis_in degeneration of the central nervous system that often impairs motor skills, speech, and other functions.; Xref MGI. OMIM mapping confirmed by DO. [SN]. |
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Administrative Information |
| NCT number |
NCT07080775 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT07080775 |
| Other study identifiers |
| Name |
XS411-Allo-LOPD-CN1/2-P01 |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT07080775 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
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| Study sites |
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| Sponsors |
XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
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| Collaborators |
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Cells |
| Which differentiated cell type is used |
| Label |
dopaminergic neuron |
| Link |
http://purl.obolibrary.org/obo/CL_0000700 |
| Description |
A neuron that releases dopamine as a neurotransmitter. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
12 |
