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Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS

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ClinicalTrials.gov Identifier: NCT01771640
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Study Description
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Brief Summary:
ALS is a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment that has been found to improve survival but only to a modest extent. It lengthens survival by several months, and may have a greater survival benefit for those with a bulbar onset. It also extends the time before a person needs ventilation support.Stem cell transplantation is a new hopeful way to improve the patients conditions and reduce the period of disabilities.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Biological: intrathecal injection Phase 1

Detailed Description:
In this study our purpose is to evaluate the safety of intraventricular injection of bone marrow derived mesenchymal stem cell.the patients who are eligible,underwent bone marrow aspiration.after cell separation and preparation,the patients underwent mesenchymal stem cell intraventricular injection by stereotaxis.after injection he will be under observed in ICU to monitor the adverse events(allergic and neurological side effects).patients are followed 1th,3th ,6th and 12 months after injection and each time these parameters are checked:ALS-FRS,EMG-NCV,FVC,side effect check list.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrathecal Transplantation of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS
Study Start Date : August 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: stem cell reciepient
The patients with ALS that underwent mesenchymal stem cell transplantation
 Biological: intrathecal injection
Intrathecal injection of mesenchymal stem cells in patients with ALS


Outcome Measures
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Primary Outcome Measures :
  1. Fever [ Time Frame: 48hours ]
    Evaluation the rate of fever during 48hour after transplantation

  2. Unconscious [ Time Frame: 48hours ]
    Evaluation the rate of unconsciousness during 48hour after transplantation

  3. Vomiting [ Time Frame: 48hours ]
    Evaluation the nausea and vomiting 48hours after transplantation.


Secondary Outcome Measures :
  1. ALS-FRS [ Time Frame: 6months ]
    Evaluation the improvement of ALS-FRS during 6months after transplantation.

  2. FVC [ Time Frame: 6months ]
    Evaluation the improvement of FVC by spirometry during 6months after transplantation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age:18-65
  • both gender
  • duration of disease<2 years
  • FVC>40% ALS-FRS>26

Exclusion Criteria:

  • neurological and psychiatric concomitant disease
  • concomitant systemic disease
  • treatment with corticosteroid,Ig,immunosuppressive during 12 months.
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): NCT01771640


Locations
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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
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Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of Royan department of degenerative medicine,Head of Royan celltherapy center
Study Director: Seyed Masoud Nabavi, MD Proffessor assistant of Shahed University
Principal Investigator: leila Arab, MD Department of regenerative medicine,Royan Institute
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01771640    
Other Study ID Numbers: Royan-Nerve-006
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: May 2012
Keywords provided by Royan Institute:
ALS intrathecal injection bone marrow mesenchymal stem cell
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases