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The purpose of this study is verify the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Spinocerebellar Ataxia, and in addition, explore the possible mechanisms of UC-MSC therapy in Spinocerebellar Ataxia.
This is a random, open label, and parallel controled experiment. 45 patients are selected and sign consent forms, then divided into three groups. Doctors collect the basic information of patient (including age,height, mental condition, vital sign, history of disease, pharmaco-history, genotype test, and so on.) All patients receive laboratory and image examination as baseline. Then, they will give cell treatment based on the clinical protocol. Doctors have follow-up visit on 1, 2, 3, 6, and 12 months after treatment, and do efficacy evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous infusion group | Experimental | Umbilical cord mesenchymal stem cells (SCLnow 19#) |
|
| Intrathecal injection group | Experimental | Umbilical cord mesenchymal stem cells (SCLnow 19#) |
|
| Control groups | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous infusion | Procedure | Intravenous infusion of mesenchymal stem cells: 2 * 10^7 cells (30ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scale for the assessment anf rating of ataxia (SARA) | Based on SARA score to calculate treatment efficacy. The equation is as follow, Efficacy = (patients who accepted treatment are effective/patients who accepted treatment)* 100% Effective: after 12 months, score of patient decrease 1 point or more; Ineffective: after 12 months, score decrease less than 1 point or increase. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Image examinations | MRI plain scan of brain. | 12 months |
| Inventory of Non-Ataxia Symptoms (INAS) score | Using Inventory of Non-Ataxia Symptoms (INAS) score to determine the presence and severity of non-ataxia signs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Guo | Contact | 861064368977 | georgeguo@sclnow.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Jiang | Xiangya Hospital of Central South University | Principal Investigator |
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| Intrathecal injection | Procedure | Intrathecal injection of mesenchymal stem cells: 2 * 10^7 cells (1ml) |
|
| umbilical cord mesenchymal stem cell | Biological | Treat patients with umbilical cord mesenchymal stem cell (SCLnow 19#), the dosage based on different procedure |
|
| 12 months |
| Cerebrospinal fluid (csf) routine | Patients is observed by professionals, compare the changes of each observation point and baseline. Baseline is the data acquire from patients before stem cells treatment. | 12 months |
| ID | Term |
|---|---|
| D020754 | Spinocerebellar Ataxias |
| D017827 | Machado-Joseph Disease |
| ID | Term |
|---|---|
| D002524 | Cerebellar Ataxia |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013132 | Spinocerebellar Degenerations |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D001259 | Ataxia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D007262 | Infusions, Intravenous |
| D007278 | Injections, Spinal |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |
| D007267 | Injections |
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