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Purpose of this phase 1 study is to assess the safety of intrathecal administration of allogeneic human oral mucosa stem cells (hOMSCs) in patients suffering from early to moderate stage Multiple System Atrophy (MSA)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose hOMSC300 | Experimental | Single IT administration of low dose hOMSC300 |
|
| High dose hOMSC300 | Experimental | Single IT administration of high dose hOMSC300 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hOMSC300 | Biological | Human Oral Mucosa Stem Cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment related serious adverse events (SAEs) | 18 months | |
| Number of participants with treatment related adverse events (AEs) | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel-Aviv Sourasky Medical Center (Ichilov) | Tel Aviv | Israel |
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Patients will be allocated to one of the following arms:
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| ID | Term |
|---|---|
| D019578 | Multiple System Atrophy |
| D012791 | Shy-Drager Syndrome |
| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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