Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS
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.
Amyotrophic Lateral Sclerosis
Biological: Intraventricular injection
|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|
- 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.
- 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.
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759784
|Contact: Nasser Aghdami, MD,PhD||+9821235622000 ext firstname.lastname@example.org|
|Contact: Leila Arab, MD||+982123562000 ext email@example.com|
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Contact: Nasser Aghdami, MD,PhD +982123562000 ext 504 firstname.lastname@example.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|
|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|