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This clinical trial investigates the safety and therapeutic potential of mesenchymal stem cell-based therapies in patients with parkinsonism.
The study evaluates neuroinduced mesenchymal stem cells and mesenchymal stem cell-derived exosomes as potential regenerative treatments targeting neurodegeneration within dopaminergic pathways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuroinduced Mesenchymal Stem Cells | Experimental | 200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion. |
|
| Mesenchymal Stem Cell Derived Exosomes | Experimental | 1×10¹¹ particles per infusion |
|
| Intravenous saline infusion | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal (IT) | Biological | Intrathecal injection of 3 ml between L4-L5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| NMSS | Change in non-motor symptoms measured by the Non-Motor Symptoms Scale (NMSS) Range: 0-360 360 indicates the greatest symptom burden, 0 - the least | 48 |
| 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 and 0 is the best | 48 |
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Inclusion Criteria:
Age 40-80 years Clinical diagnosis of Parkinsonism Hoehn and Yahr stage II-III Stable pharmacological treatment for ≥3 months
Exclusion Criteria:
Atypical parkinsonian syndromes unrelated to neurodegeneration History of malignancy within 5 years Severe cardiovascular disease Prior cellular therapy Active infection or immunosuppression
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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 |
|---|---|---|---|---|---|---|
| Neuropostep | Warsaw | 02-797 | Poland |
|
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| Intravenous | Biological | Intravenous injection via a drip |
|
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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