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Recruitment Status : Withdrawn (The stereotaxis can be threatful for the patients because of respiratory insufficiency)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
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Biological: Intraventricular injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- fever [ Time Frame: 48hours ]evaluation the rate of fever 48hours after stem cell injection
- unconsciousness [ Time Frame: 6months ]evaluation the rate of unconsciousness during 6months after stem cell injection.
- brain hematoma [ Time Frame: 48hours ]Evaluation the rate of hematoma 48hours after stem cell injection.
- vomiting [ Time Frame: 48hours ]evaluation the rate of vomiting 48hours after stem cell injection.
- ALS-FRS [ Time Frame: 6months ]evaluation the improvement of ALS-FRS 6months after stem cell injection.
- EMG-NCV [ Time Frame: 6months ]evaluation the improvement of EMG-NCV after stem cell injection.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759784
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|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|