Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS
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|ClinicalTrials.gov Identifier: NCT02492516|
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Biological: mesenchymal stem cells||Phase 1|
|Study Type :||Interventional|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||April 2017|
Experimental: Stem cell
The patients with diagnosis of ALS who receive adipose derived mesenchymal stem cell.
Biological: mesenchymal stem cells
mesenchymal stem cells injection via peripheral vein.
- fever [ Time Frame: 72hours ]The increase of body temperature that is defined as fever, within 72 hours after injection.
- Unconsciousness [ Time Frame: 72hours ]Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.
- The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) [ Time Frame: 2 months ]Evaluation the improvement of ALS functional rating scale ( ALS-FRS) by ALS-FRS questionnare, 2 months after cell injection.
- FVC [ Time Frame: 2 months ]Evaluation the improvement of FVC by spirometry, 2 months after 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): NCT02492516
|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 department of Regenerative Medicine,Royasn Institute|
|Study Director:||Masood Nabavi, MD||Professor associated of neurology, Shahed University|
|Principal Investigator:||Leila Arab, MD||Department of Regenerative Medicine, Royan Institute|