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The purpose of the clinical trial is to study the therapeutic efficacy and safety of Stemchymal® infusions for polyglutamine spinocerebellar ataxia treatment by a randomized, double-blind, placebo-controlled study design. Eligible subjects will receive Stemchymal® through intravenous infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stemchymal® | Experimental | Infusion of Stemchymal® |
|
| Vehicle | Placebo Comparator | Infusion of excipients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stemchymal® | Biological | Patients will receive Stemchymal® through intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the changes from the baseline to all visits on Scale for the Assessment and Rating of Ataxia (SARA) score. | 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety by incidence of adverse events, changes of vital signs, blood biochemistry tests, complete blood count, immunoactivity assay, urinalysis and magnetic resonance imaging (MRI). | 14 months | |
| To assess the changes from the baseline to all visits on SCA functional index (SCAFI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D002524 | Cerebellar Ataxia |
| D020754 | Spinocerebellar Ataxias |
| ID | Term |
|---|---|
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005079 | Excipients |
| ID | Term |
|---|---|
| D014677 | Pharmaceutical Vehicles |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
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| Excipients |
| Procedure |
Patients will receive excipients through intravenous infusion |
|
| 14 months |
| To assess the changes from the baseline to all visits on sensory organization test (SOT) | Balance test | 14 months |
| To assess the changes from the baseline to all visits on inventory of non-ataxia signs (INAS) | 14 months |
| To assess the changes from the baseline to all visits on clinical global impression (CGI) | 14 months |
| To assess the changes from the baseline to all visits on patient global impression of improvement (PGI-I) | 14 months |
| D001259 | Ataxia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013132 | Spinocerebellar Degenerations |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020164 | Chemical Actions and Uses |