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This clinical study aims to evaluate the safety and preliminary therapeutic potential of mesenchymal stem cell-derived therapies in patients diagnosed with spinocerebellar palsy. The investigational treatment includes neuroinduced mesenchymal stem cells and their derived exosomes administered via intravenous and intranasal infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuroinduced Mesenchymal Stem Cells | Experimental |
| |
| Mesenchymal Stem Cell Derived Exosomes | Experimental |
| |
| Saline solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal infusion | Drug | 200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MDS-UPDRS | Change in motor symptoms measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III - Motor Examination Range: 0-132 Where 132 is the worst motor impairment; 0 - the best motor impairment | 92 weeks |
| SARA | Change in motor function as measured by the Scale for the Assessment and Rating of Ataxia (SARA) Range: 0-40 40 - the most severe ataxia; 0 - the mildest | 92 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ICARS | Change in neurological function measured by the International Cooperative Ataxia Rating Scale (ICARS) Range: 0-100 100 is the worst neurological impairment; 0 - the best | 92 weeks |
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Inclusion Criteria:
Clinical diagnosis of spinocerebellar palsy confirmed by neurological examination; Disease duration ≤10 years; Ability to provide informed consent.
Exclusion Criteria:
Severe systemic illness; Active infection; History of malignancy within 5 years; Prior stem cell therapy; Pregnancy or breastfeeding.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrei Peskau | Contact | +48452365311 | info@biocellsmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioCells Medical | Warsaw | 02-797 | Poland |
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| Intranasal infusion | Drug | Intranasal infusion of purified exosomes derived from mesenchymal stem cells |
|
| ID | Term |
|---|---|
| D001259 | Ataxia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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