Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Royan Institute
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01771640
First received: January 16, 2013
Last updated: April 24, 2014
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: intrathecal 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: Intrathecal Transplantation of Autologous 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 during 48hour after transplantation

  • Unconscious [ Time Frame: 48hours ] [ Designated as safety issue: Yes ]
    Evaluation the rate of unconsciousness during 48hour after transplantation

  • Vomiting [ Time Frame: 48hours ] [ Designated as safety issue: Yes ]
    Evaluation the nausea and vomiting 48hours after transplantation.


Secondary Outcome Measures:
  • ALS-FRS [ Time Frame: 6months ] [ Designated as safety issue: No ]
    Evaluation the improvement of ALS-FRS during 6months after transplantation.

  • FVC [ Time Frame: 6months ] [ Designated as safety issue: No ]
    Evaluation the improvement of FVC by spirometry during 6months after transplantation


Estimated Enrollment: 10
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 65 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771640

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         
Sub-Investigator: vagihe azimian, PhD student         
Sub-Investigator: Soura Mardpour, MSc         
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: Seyed Masoud Nabavi, MD Proffessor assistant of Shahed University
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01771640     History of Changes
Other Study ID Numbers: Royan-Nerve-006
Study First Received: January 16, 2013
Last Updated: April 24, 2014
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
ALS intrathecal injection bone marrow mesenchymal stem cell

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

ClinicalTrials.gov processed this record on September 22, 2014