Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS

This study is currently recruiting participants.
Verified May 2012 by Royan Institute
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01759784
First received: December 29, 2012
Last updated: March 13, 2013
Last verified: May 2012
  Purpose

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 Intervention Phase
Amyotrophic Lateral Sclerosis
Biological: Intraventricular injection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Intraventricular Injection of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • fever [ Time Frame: 48hours ] [ Designated as safety issue: Yes ]
    evaluation the rate of fever 48hours after stem cell injection

  • unconsciousness [ Time Frame: 6months ] [ Designated as safety issue: Yes ]
    evaluation the rate of unconsciousness during 6months after stem cell injection.

  • brain hematoma [ Time Frame: 48hours ] [ Designated as safety issue: Yes ]
    Evaluation the rate of hematoma 48hours after stem cell injection.

  • vomiting [ Time Frame: 48hours ] [ Designated as safety issue: Yes ]
    evaluation the rate of vomiting 48hours after stem cell injection.


Secondary Outcome Measures:
  • ALS-FRS [ Time Frame: 6months ] [ Designated as safety issue: No ]
    evaluation the improvement of ALS-FRS 6months after stem cell injection.

  • EMG-NCV [ Time Frame: 6months ] [ Designated as safety issue: No ]
    evaluation the improvement of EMG-NCV after stem cell injection.


Estimated Enrollment: 10
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759784

Contacts
Contact: Nasser Aghdami, MD,PhD +9821235622000 ext 504 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD +982123562000 ext 414 leara91@gmail.com

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    +982123562000 ext 504    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, MD    +982123562000 ext 414    Leara91@gmail.com   
Principal Investigator: Leila Arab, MD         
Principal Investigator: Farzad Ashraafi, MD         
Sub-Investigator: Soura Mardpour, MSc         
Sub-Investigator: Vagihe Azimian, PhD student         
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
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01759784     History of Changes
Other Study ID Numbers: Royan-Nerve-004
Study First Received: December 29, 2012
Last Updated: March 13, 2013
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

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

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014