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Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS

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ClinicalTrials.gov Identifier: NCT01759784
Recruitment Status : Withdrawn (The stereotaxis can be threatful for the patients because of respiratory insufficiency)
First Posted : January 3, 2013
Last Update Posted : January 1, 2016
Sponsor:
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: Intraventricular 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Intraventricular Injection of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS
Study Start Date : March 2014
Estimated Primary Completion Date : March 2017


Arm Intervention/treatment
Experimental: stem cell recipient
The patients who underwent mesenchymal stem cell transplantation.
Biological: Intraventricular injection
intraventricular injection of mesenchymal stem cell by stereo taxi in patients with ALS
Other Name: intraventricular injection of mesenchymal stem cell by stereotaxis




Primary Outcome Measures :
  1. fever [ Time Frame: 48hours ]
    evaluation the rate of fever 48hours after stem cell injection

  2. unconsciousness [ Time Frame: 6months ]
    evaluation the rate of unconsciousness during 6months after stem cell injection.

  3. brain hematoma [ Time Frame: 48hours ]
    Evaluation the rate of hematoma 48hours after stem cell injection.

  4. vomiting [ Time Frame: 48hours ]
    evaluation the rate of vomiting 48hours after stem cell injection.


Secondary Outcome Measures :
  1. ALS-FRS [ Time Frame: 6months ]
    evaluation the improvement of ALS-FRS 6months after stem cell injection.

  2. EMG-NCV [ Time Frame: 6months ]
    evaluation the improvement of EMG-NCV after stem cell injection.



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Ages Eligible for Study:   18 Years to 70 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.

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): NCT01759784


Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
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: Ali Reza Zali, MD Head of Neurosurgery research center of Shahid Beheshti University

Additional Information:
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01759784     History of Changes
Other Study ID Numbers: Royan-Nerve-004
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: May 2012

Keywords provided by Royan Institute:
mesenchymal stem cell intraventricular injection ALS

Additional relevant MeSH terms:
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