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Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS

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. Identifier: NCT01759797
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : July 6, 2016
Information provided by (Responsible Party):
Royan Institute

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: intra venous injection of stem cell 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Intravenous Transplantation of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: stem cell reciepient
the patients with ALS who underwent intravenous injection of mesenchymal stem cell.
Biological: intra venous injection of stem cell
Intra venous injection of mesenchymal stem cell
Other Name: Stem cell transplantation

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

  2. Unconsciousness [ Time Frame: 48hours ]
    Evaluation the rate of unconsciousness 48hours after cell transplantation.

  3. vomiting [ Time Frame: 48hours ]
    Evaluation the rate of vomiting 48hours after cell transplantation.

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

  2. FVC [ Time Frame: 6months ]
    Evaluation the improvement of FVC (spectrometry )in patients after cell transplantation.

  3. EMG-NCV [ Time Frame: 6months ]
    Evaluation the improvement of EMG-NCV during 6 months after cell transplantation.

Information from the National Library of Medicine

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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

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.

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 identifier (NCT number): NCT01759797

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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
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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
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Royan Institute Identifier: NCT01759797    
Other Study ID Numbers: Royan-Nerve-005
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: May 2012
Keywords provided by Royan Institute:
ALS bone marrow mesenchymal stem cell intravenous injection
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