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| ID | Type | Description | Link |
|---|---|---|---|
| 20111031limin | Other Identifier | neuralstemcell |
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Hereditary cerebellar ataxia is a type of autosomal dominant genetic disease, lesions mainly involving the cerebellum, but the spinal cord and cranial nerves may also be some involvement. A total of 20 molecularly diagnosed SCA1 patients divided in two groups. One group accepted for the treatment of stem cell transplantation,the other group will be the control. Purpose of this project to prove that allogeneic umbilical cord mesenchymal stem cells are applied to clinical safely, and in the treatment of hereditary cerebellar ataxia is valid.
After admission the patients accepted transplantation would receive physical examination, blood and urine tests, electrocardiogram, electrophysiologic study;evaluation of SCA1 symptoms (balance, walking, dexterity, tremor, memory, mood and concentration),then stem cell therapy：after stem cell prepared, the patients accepted 4 times stem cell transplantations through lumbar puncture, the time is 3-5days between two treatments. The control only receive evaluation of SCA1 symptoms .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Ten patients in the group only receive nerve functional evaluation and electrophysiology examination before and 1,3,6,12 months after recruit. They will not accept cell therapy. | |
| Stem cell transplantation | Experimental | 10 patients in the group accept stem cell transplantation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stem cell transplantation | Other | The patients accepted 4 times stem cell transplantations through lumbar puncture, the time is 3-5days between two treatments and the dose is about 2 ml(including 1×10'7 cells). |
| Measure | Description | Time Frame |
|---|---|---|
| blood test | white blood cell、neutrophilic granulocyte、leukomonocyte；glutamic pyruvic transaminase(GPT)、glutamic oxalacetic transaminase、lactate dehydrogenase(LDH)、;hydroxybutyrate dehydrogenase(HBDH)、phosphocreatine kinase(CK)；acidum uricum(UA)、creatinine(Cr)、α1- microglobulin、β2- microglobulin；lymphotoxin(LCT). Tumor markers(AFP,CEA,CA125,CA15-3,CA19-9,CA72-4CY21-1,NSE) ,Lymphocytes classification | within one week before transplantation |
| Nerve functional evaluation |
| within one week before transplantation |
| blood test | white blood cell、neutrophilic granulocyte、leukomonocyte；glutamic pyruvic transaminase(GPT)、glutamic oxalacetic transaminase、lactate dehydrogenase(LDH)、;hydroxybutyrate dehydrogenase(HBDH)、phosphocreatine kinase(CK)；acidum uricum(UA)、creatinine(Cr)、α1- microglobulin、β2- microglobulin；lymphotoxin(LCT). Tumor markers(AFP,CEA,CA125,CA15-3,CA19-9,CA72-4CY21-1,NSE) ,Lymphocytes classification | 1 month after transplantation |
| blood test | white blood cell、neutrophilic granulocyte、leukomonocyte；glutamic pyruvic transaminase(GPT)、glutamic oxalacetic transaminase、lactate dehydrogenase(LDH)、;hydroxybutyrate dehydrogenase(HBDH)、phosphocreatine kinase(CK)；acidum uricum(UA)、creatinine(Cr)、α1- microglobulin、β2- microglobulin；lymphotoxin(LCT). Tumor markers(AFP,CEA,CA125,CA15-3,CA19-9,CA72-4CY21-1,NSE) ,Lymphocytes classification | 3 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Urinal test | proteinum、akaryocyte、α1- microglobulin、β2- microglobulin | within one week before transplantation |
| Electrophysiology examination | somatosensory evoked potential(SEP)、brain stem auditory evoked potential(BAEP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yihua An, doctor | director of neural stem cell transplantation department in general hospital of chinese armed police forces | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yihua An | Beijing | China |
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| ID | Term |
|---|---|
| D013132 | Spinocerebellar Degenerations |
| D002524 | Cerebellar Ataxia |
| D030342 | Genetic Diseases, Inborn |
| ID | Term |
|---|---|
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
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|
| blood test |
white blood cell、neutrophilic granulocyte、leukomonocyte；glutamic pyruvic transaminase(GPT)、glutamic oxalacetic transaminase、lactate dehydrogenase(LDH)、;hydroxybutyrate dehydrogenase(HBDH)、phosphocreatine kinase(CK)；acidum uricum(UA)、creatinine(Cr)、α1- microglobulin、β2- microglobulin；lymphotoxin(LCT). Tumor markers(AFP,CEA,CA125,CA15-3,CA19-9,CA72-4CY21-1,NSE) ,Lymphocytes classification |
| 6 months after transplantation |
| blood test | white blood cell、neutrophilic granulocyte、leukomonocyte；glutamic pyruvic transaminase(GPT)、glutamic oxalacetic transaminase、lactate dehydrogenase(LDH)、;hydroxybutyrate dehydrogenase(HBDH)、phosphocreatine kinase(CK)；acidum uricum(UA)、creatinine(Cr)、α1- microglobulin、β2- microglobulin；lymphotoxin(LCT). Tumor markers(AFP,CEA,CA125,CA15-3,CA19-9,CA72-4CY21-1,NSE) ,Lymphocytes classification | 12 months after transplantation |
| Nerve functional evaluation |
| 1 month after transplantation |
| Nerve functional evaluation |
| 3 months after transplantation |
| Nerve functional evaluation |
| 6 months after transplantation |
| Nerve functional evaluation |
| 12 months after transplantation |
| within one week before transplantation |
| Urinal test | proteinum、akaryocyte、α1- microglobulin、β2- microglobulin | 1 month after transplantation |
| Urinal test | proteinum、akaryocyte、α1- microglobulin、β2- microglobulin | 3 months after transplantation |
| Urinal test | proteinum、akaryocyte、α1- microglobulin、β2- microglobulin | 6 months after transplantation |
| Urinal test | proteinum、akaryocyte、α1- microglobulin、β2- microglobulin | 12 months after transplantation |
| Electrophysiology examination | somatosensory evoked potential(SEP)、brain stem auditory evoked potential(BAEP) | 1 month after transplantation |
| Electrophysiology examination | somatosensory evoked potential(SEP)、brain stem auditory evoked potential(BAEP) | 3 months after transplantation |
| Electrophysiology examination | somatosensory evoked potential(SEP)、brain stem auditory evoked potential(BAEP) | 6 months after transplantation |
| Electrophysiology examination | somatosensory evoked potential(SEP)、brain stem auditory evoked potential(BAEP) | 12 months after transplantation |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001259 | Ataxia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |