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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
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Procedure: stem cell transplantation Phase 2

Detailed Description:
A total of 30 diagnosed ALS patients. The patients would got these symptoms such as gait difficulty and tremor, hand incoordination or speech difficulties.

Study Design
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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

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Arms and Interventions
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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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Nerve functional evaluation [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]
    1. Medical Research Council scale：To determine the strength of bilateral little finger abductor muscle and anterior tibial.
    2. To evaluate the situation of upper motor neuron impairment through the Ellis reflex scale
    3. The severity evaluation: NorrisALS score and ALS functional rating scale, ALSFRS
    4. Speed of disease progression by the following formula：Progress rate = (40-ALSFRS score) / course
    5. Questionnaires related to sleep, depression (Beck Depression Inventory) (BDI) and memory (Mini Mental State Examination)

  2. 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）


Secondary Outcome Measures :
  1. 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+

  2. 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

  3. Electrophysiology examination [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]
    motor evoked potential(MEP)、nerve conduction and electromyologram(EMG)


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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


Locations
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China
Yihua An
Beijing, China
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
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Study Director: YiHua An Chinese People's Armed Police Force
More Information
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Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01494480     History of Changes
Other Study ID Numbers: 20111207ALS
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012
Keywords provided by General Hospital of Chinese Armed Police Forces:
ALS
stem cell
Additional relevant MeSH terms:
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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