The Clinical Trial on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis
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ClinicalTrials.gov Identifier: NCT01494480 |
Recruitment Status : Unknown
Verified June 2012 by General Hospital of Chinese Armed Police Forces.
Recruitment status was: Enrolling by invitation
First Posted : December 19, 2011
Last Update Posted : June 20, 2012
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Condition or disease | Intervention/treatment | Phase |
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Amyotrophic Lateral Sclerosis | Procedure: stem cell transplantation | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Clinical Study on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis |
Study Start Date : | March 2012 |
Estimated Primary Completion Date : | January 2013 |
Estimated Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: stem cell transplantation
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.
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Procedure: stem cell transplantation
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.
Other Name: the stem cell treatment of ALS |
- Nerve functional evaluation [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]
- Medical Research Council scale:To determine the strength of bilateral little finger abductor muscle and anterior tibial.
- To evaluate the situation of upper motor neuron impairment through the Ellis reflex scale
- The severity evaluation: NorrisALS score and ALS functional rating scale, ALSFRS
- Speed of disease progression by the following formula:Progress rate = (40-ALSFRS score) / course
- Questionnaires related to sleep, depression (Beck Depression Inventory) (BDI) and memory (Mini Mental State Examination)
- Forced vital capacity [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]vital capacity(VC)、forced vital capacity( FVC)、forced expiratory volune(FEV1)、FEV1/FVC、maximal voluntary ventilation(MVV)、peak expiratory flow(PEF)
- Blood test [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]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+
- Urinal test [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]proteinum、akaryocyte、α1- microglobulin、β2- microglobulin. CSF test::IgA, IgG quantitation
- Electrophysiology examination [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]motor evoked potential(MEP)、nerve conduction and electromyologram(EMG)

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Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnose established following the World Federation of Neurology criteria
- More than 6 and less than 36 months of evolution of the disease
- Medullar onset of the disease
- More than 20 and less than 65 years old
- Forced Vital Capacity equal or superior to 50%
- Total time of oxygen saturation <90% inferior to 2% of the sleeping time
- Signed informed consent
Exclusion Criteria:
- Neurological or psychiatric concomitant disease
- Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
- Concomitant systemic disease
- Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
- Inclusion in other clinical trials
- Unability to understand the informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494480
China | |
Yihua An | |
Beijing, China |
Study Director: | YiHua An | Chinese People's Armed Police Force |
Responsible Party: | General Hospital of Chinese Armed Police Forces |
ClinicalTrials.gov Identifier: | NCT01494480 |
Other Study ID Numbers: |
20111207ALS |
First Posted: | December 19, 2011 Key Record Dates |
Last Update Posted: | June 20, 2012 |
Last Verified: | June 2012 |
ALS stem cell |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |