Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS
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|ClinicalTrials.gov Identifier: NCT01759797|
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : July 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Biological: intra venous injection of stem cell||Phase 1|
|Study Type :||Interventional|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Intravenous Transplantation of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||March 2014|
Experimental: stem cell reciepient
the patients with ALS who underwent intravenous injection of mesenchymal stem cell.
Biological: intra venous injection of stem cell
Intra venous injection of mesenchymal stem cell
Other Name: Stem cell transplantation
- Fever [ Time Frame: 48hours ]Evaluation the rate of fever 48 hours after cell transplantation
- Unconsciousness [ Time Frame: 48hours ]Evaluation the rate of unconsciousness 48hours after cell transplantation.
- vomiting [ Time Frame: 48hours ]Evaluation the rate of vomiting 48hours after cell transplantation.
- ALS-FRS [ Time Frame: 6months ]Evaluation the improvement of ALS-FRS during 6months after cell transplantation.
- FVC [ Time Frame: 6months ]Evaluation the improvement of FVC (spectrometry )in patients after cell transplantation.
- EMG-NCV [ Time Frame: 6months ]Evaluation the improvement of EMG-NCV during 6 months after cell transplantation.
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): NCT01759797
|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:||Seyed Masoud Nabavi, MD||Proffessor assistant of Shahed University|