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Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02116634
Recruitment Status : Withdrawn (Because economic problems)
First Posted : April 17, 2014
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
rokhsareh meamar, Alzahra Hospital, Iran

Study Description
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Brief Summary:
Whether the mesenchymal injection on ALS patients is effective or not?

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Biological: mesenchymal stem cell Phase 1 Phase 2

Detailed Description:
After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: mesenchymal stem cell
intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline
 Biological: mesenchymal stem cell
intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline


Outcome Measures
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Primary Outcome Measures :
  1. Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS [ Time Frame: every 6 months up 2 years after transplantation ]

Secondary Outcome Measures :
  1. ALS-FRS(functional rating scale) score and EMG scale [ Time Frame: before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation ]
  2. FVC (forced vital capacity)and DWSE±QoL score [ Time Frame: before transplantation and every 6 months up 2 years after transplantation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. sporadic ALS according to escorial criteria
  2. onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
  3. mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount
  4. normal polysomnography
  5. Signed consent form

Exclusion Criteria:

  1. pregnancy or lactation,
  2. vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease
  3. Hospitalization due to serious illness in the last two months
  4. survival time less than two years
  5. Hypersensitivity to any component used in the cell culture
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02116634


Locations
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Iran, Islamic Republic of
Neurosciences Research Center
Isfahan, Iran, Islamic Republic of, 0098311
Sponsors and Collaborators
Alzahra Hospital, Iran
Investigators
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Principal Investigator: keivan basiri, MD Isfahan neurosciences research center
More Information
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Responsible Party: rokhsareh meamar, Principal Investigator, Alzahra Hospital, Iran
ClinicalTrials.gov Identifier: NCT02116634    
Other Study ID Numbers: rokhsareh
stem cell injection in ALS ( Other Identifier: iran national science foundation )
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016
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