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Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intrathecal injection of umbilical cord mesenchymal stem cells can secret trophic factors that keep the motorneurons functional. The investigators have designed a phase I/II clinical trial to check the feasibility of this approach in humans.
A total of 30 diagnosed ALS patients. The patients would got these symptoms such as gait difficulty and tremor, hand incoordination or speech difficulties.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stem cell transplantation | Experimental | After stem cell prepared, the patients accepted 4 times stem cell transplantations through lumbar puncture, the time is 3-5days between two treatments. The patient would have to be in the bed at least 6 hours and removed the pillow. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stem cell transplantation | Procedure | after stem cell prepared, the patients accepted 4 times stem cell transplantations through lumbar puncture, the time is 3-5days between two treatments. The patient would have to be in the bed at least 6 hours and removed the pillow. |
| Measure | Description | Time Frame |
|---|---|---|
| Nerve functional evaluation |
| within one week before,1month,6months,12months and 24months after transplantation |
| Forced vital capacity | vital capacity(VC)、forced vital capacity( FVC)、forced expiratory volune(FEV1)、FEV1/FVC、maximal voluntary ventilation(MVV)、peak expiratory flow(PEF) | within one week before,1month,6months,12months and 24months after transplantation |
| 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 , Lymphocytes classification, cholesterol total、Triglyceride、low density lipoprotein、Glycosylated serum protein glycosylated hemoglobin、Islet function,Na+、K+ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YiHua An | Chinese People's Armed Police Force | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yihua An | Beijing | China |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
| within one week before,1month,6months,12months and 24months after transplantation |
| Urinal test | proteinum、akaryocyte、α1- microglobulin、β2- microglobulin. CSF test::IgA, IgG quantitation | within one week before,1month,6months,12months and 24months after transplantation |
| Electrophysiology examination | motor evoked potential(MEP)、nerve conduction and electromyologram(EMG) | within one week before,1month,6months,12months and 24months after transplantation |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |