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Recruitment Status : Withdrawn (The stereotaxis can be threatful for the patients because of respiratory insufficiency)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|
|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.
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
|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|