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Intraspinal Delivery of Bone Marrow Stromal Cell-Derived Neural Stem Cells in Patients With Amyotrophic Lateral Sclerosis: A Safety and Feasibility Study Publisher Pubmed



Nafissi S1, 2 ; Kazemi H1, 3 ; Tiraihi T4 ; Beladimoghadam N5 ; Faghihzadeh S6 ; Faghihzadeh E7 ; Yadegarynia D8 ; Sadeghi M9 ; Chamanitabriz L10 ; Khanfakhraei A11 ; Taheri T11
Authors
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Authors Affiliations
  1. 1. Shefa Neuroscience Research Center, Khatam-Alanbia Hospital, Tehran, Iran
  2. 2. Iranian Center of Neurological Research, Department of Neurology, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Faculty of Medicine, Shahed University, Tehran, Iran
  4. 4. Faculty of Medical Science, Tarbiat Modares University, Tehran, Iran
  5. 5. Department of Neurology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  6. 6. Department of Biostatistics and Epidemiology, Shariati Hospital, School of Medicine, Zanjan University of Medical Science, North Karegar Street, Zanjan, Tehran, 14114, Iran
  7. 7. Immunoregulation Research Center, Shahed University, Tehran, Iran
  8. 8. Department of Infectious Disease, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  9. 9. Department of Anesthesiology, Tehran University of Medical Sciences, Tehran, Iran
  10. 10. Reproductive Biotechnology Research Center, Avicenna Research Institute, Tehran, Iran
  11. 11. Department of Spinal Cord Injury, Shefa Neuroscience Research Center, Khatam-Alanbia Hospital, Tehran, Iran

Source: Journal of the Neurological Sciences Published:2016


Abstract

Background Stem cells have been used in several studies with different methodologies to treat patients with ALS. Methods In this safety and feasibility study, 11 patients with definite or probable ALS according to El Escorial criteria were selected. 3 patients were excluded due to inadequate bone marrow or safety measures after acquisition of bone marrow. Bone marrow stromal cell-derived neural stem cells were injected in C7-T1 spinal cord under general anesthesia. Patients were followed for 12 months after injection with manual muscle testing, ALSFRS-R, quality of life changes, pulmonary function test and electromyography. Results None of the patients had perioperative mortality or major morbidity. One patient had temporary deterioration in lower extremities after injection which improved after a few weeks. In the 12 months post-injection, only one patient died due to pulmonary embolism. From the remaining 7 patients, all had a stable course after 4 months and 5 were stable for the first 8 months post-injection and deteriorated afterwards. Discussion In this study, intraspinal injection of bone marrow derived neural stem cells appears to be safe. Patients experienced a temporary stabilization for the first few months post-injection and then gradually deteriorated. © 2016 Elsevier B.V. All rights reserved.