UKRAINS'KYI VISNYK PSYKHONEVROLOHII

The Scientific and Practical Journal of Medicine
ISSN 2079-0325(p)
DOI 10.36927/2079-0325

PROTOCOL FOR THE TREATMENT OF PATIENTS WITH A SPECTRUM OF OPTOMYELITIS-ASSOCIATED DISORDERS BY INJECTION OF BONE MARROW STROMAL CELLS IN THE CONDITIONS OF THE INSTITUTE OF NEUROLOGY, PSYCHIATRY AND NARCOLOGY OF THE NSAN OF UKRAINE

Type of Article

In the Section

Abstract

diagnosis Diseases from the spectrum of neuromyelitis optica spectrum disorders (NMOSD).
Code for ICH 10: G36.0
Patient category: patients with optomyelitis-associated disorders.
Recognition protocol for doctors who treat patients with NMOSD.
Meta Protocol: creation of an algorithm for NMOSD therapy by injecting bone marrow stromal cells, slowing the progression of the disease, reducing the disability of patients with NMOSD.

Pages

References

  1. Modi G. Demyelinating disorder of the central nervous system occurring in black South Africans // Journal of Neurology, Neurosurgery & Psychiatry. 2001. Vol. 7. No. 4. Р. 500—505.
  2. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders / D. M. Wingerchuk, В. Banwell, J. Вennett [et al.] // Neurology. 2015. 85(2). Р. 177—189. DOI: https://doi.org/10.1212/WNL.0000000000001729.
  3. Yavorskaya V. A., Grebenyuk A. V., Severin Yu. V., Krivchun V. M. Zabolevaniya spektra optikonevromielita: Obzor sovremennyih dannyih i sobstvennyie klinicheskie nablyudeniya. Georgian Medical News. 2019. No. 6 (291). S. 74—81. URL: https://cdn.website-editor.net/480918712df344a4a77508d4cd7815ab/files/uploaded/V291_N6_June_2019.pdf.
  4. Wingerchuk D. M. The spectrum of neuromyelitis optica // The Lancet Neurology. 2007. Vol. 6, no. 9. Р. 805—815.
  5. Jarius S. The history of neuromyelitis optica / S. Jarius, B. Wildemann // Journal of neuroinflammation 2013. Vol. 10, no. 1. Р. 797.
  6. Lennon V. A. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis // The Lancet. 2004. Vol. 364, no. 9451. Р. 2106—2112.
  7. Lennon V. A. IgG marker of optic-spinal multiple sclerosis binds to the aquaporin-4 water channel // Journal of Experimental Medicine. 2005. Vol. 202, no. 4. Р. 473—477.
  8. Wingerchuk D. M. Neuromyelitis optica (Devic’s syndrome) / D. M. Wingerchuk, B. G. Weinshenker // Handbook of clinical neurology. Elsevier. 2014. Vol. 122. P. 581—599.
  9. Drori T. Diagnosis and classification of neuromyelitis optica (Devic’s syndrome) / T. Drori, J. Chapman // Autoimmunity reviews. 2014. Vol. 13, 4—5. Р. 531—533.
  10. Asgari N. A population-based study of neuromyelitis optica in Caucasians // Neurology. 2011. Vol. 76, no. 18. Р. 1589—1595.
  11. Saadoun S. Intra-cerebral injection of neuromyelitis optica immunoglobulin G and human complement produces neuromyelitis optica lesions in mice // Brain. 2010. Vol. 133, Issue 2. Р. 349—361. DOI: https://doi.org/10.1093/brain/awp309.
  12. Antibody to aquaporin-4 in the long-term course of neuromyelitis optica / S. Jarius, F. Aboul-Enein, P. Waters [et al.] // Brain. 2008. Vol. 131 (11). Р. 3072—3080. DOI: https://doi.org/10.1093/brain/awn240.
  13. Anti-aquaporin-4 antibody is involved in the pathogenesis of NMO: a study on antibody titre / T. Takahashi, K. Fujihara, I. Nakashima [et al.] // Brain. 2007. Vol. 130 (5). Р. 1235—1243. DOI: https://doi.org/10.1093/brain/awm062.
  14. Multilineage potential of adult human mesenchymal stem cells / M. F. Pittenger, A. M. Mackay, S. C. Beck [et al.] // Science. 284(5411). Р. 143—147. DOI: https://doi.org/10.1126/science.284.5411.143.
  15. Human mesenchymal stem cells express neural genes, suggesting a neural predisposition / N. R. Blondheim, Y. Levy, T.  A.  Ben-Zur [et  al.]  //  Stem  Cells  Development. 2006. Vol. 15, No. 2 Р. 141—164. DOI: https://doi.org/10.1089/scd.2006.15.141.
  16. Kassis I. Bone marrow mesenchymal stem cells: agents of immunomodulation and neuroprotection / I. Kassis, A. VakninDembinsky, D. Karussis // Curr Stem Cell Res Ther. 2011. 6 (1). Р. 63—68. DOI: https://doi.org/10.2174/157488811794480762.
  17. Uccelli A. Mesenchymal stem cells: a new strategy for immunosuppression? / A. Uccelli, V. Pistoia, L. Moretta // Trends Immunol. 2007. 28 (5). Р. 219—226. DOI: https://doi.org/10.1016/j.it.2007.03.001.
  18. Ben-Hur T. Immunomodulation by neural stem cells // J Neurol Sci. 2008. 265 (1—2). Р. 102—104. DOI: https://doi.org/10.1016/j.jns.2007.05.007.
  19. Nauta A. J. Immunomodulatory properties of mesenchymal stromal cells / A. J. Nauta, W. E. Fibbe // Blood. 2007. 110 (10). Р. 3499—3506. DOI: https://doi.org/10.1182/blood-2007-02-069716.
  20. Neuroprotection and immunomodulation with mesenchymal stem cells in chronic experimental autoimmune encephalomyelitis / I. Kassis, N. Grigoriadis, B. Gowda-Kurkalli [et al.] // Arch Neurol. 2008. 65 (6). Р. 753—761. DOI: https://doi.org/10.1001/archneur.65.6.753.
  21. Mesenchymal stem cells ameliorate experimental autoimmune encephalomyelitis inducing T-cell anergy / E. Zappia, S. Casazza, E. Pedemonte [et al.] // Blood. 2005. Vol. 106, Issue 5. Р. 1755—1761. DOI: https://doi.org/10.1182/blood-2005-04-1496.
  22. Uccelli A. Mesenchymal stem cells in health and disease / A. Uccelli, L. Moretta, V. Pistoia // Nat Rev Immunol. 2008. No. 8. Р. 726—736. DOI: https://doi.org/10.1038/nri2395.
  23. Clinical and pathological effects of intrathecal injection of mesenchymal stem cell-derived neural progenitors in an experimental model of multiple sclerosis / V. K. Harris, Q. J. Yan, T. Vyshkina [et al.] // J Neurol Sci. 2012. 313 (1-2). 167—177. DOI: https://doi.org/10.1016/j.jns.2011.08.036.
  24. Injection of adult neurospheres induces recovery in a chronic model of multiple sclerosis / Pluchino S., Quattrini A., Brambilla E. [et al.] // 2003. 422: 688—94. DOI: https://doi.org/10.1038/nature01552.
  25. Human neural stem cells ameliorate autoimmune encephalomyelitis in non-human primates / Pluchino S., Gritti A., Blezer E. [et al.] // Ann Neurol. 2009. 66: 343—54. DOI: https://doi.org/10.1002/ ana.21745.
  26. Transplanted multipotential neural precursor cells migrate into the inflamed white matter in response to experimental autoimmune encephalomyelitis / T. Ben-Hur, O. Einstein, R. Mizrachi-Kol [et ]  // Glia. 2003. No.  41. Р. 73—80. DOI: https://doi.org/10.1002/glia.10159.
  27. Karussis D. Clinical experience with stem cells and other cell therapies in neurological diseases / D. Karussis, P. Petrou, I. Kassis // J Neurol Sci. 2013. 324 (1-2). Р. 1—9. DOI: https://doi.org/10.1016/j.jns.2012.09.031.
  28. Therapeutic benefit of intracerebral transplantation of bone marrow stromal cells after cerebral ischemia in rats / J. Chen, Y. Li, L. Wang [et al.] // J Neurol Sci. 2001. 189 (1-2). Р. 49—57. DOI: https://doi.org/10.1016/s0022-510x(01)00557-3.
  29. Safety and immunological effects of mesenchymal stem cell transplantation in patients with multiple sclerosis and amyotrophic lateral sclerosis / D. Karussis, C. Karageorgiou, A. Vaknin-Dembinsky [et al.] // Arch Neurol. 2010. No. 67 (10). Р. 1187—1194. DOI: https://doi.org/10.1001/archneurol.2010.248.
  30. A randomized trial of mesenchymal stem cells in multiple system atrophy / P. H. Lee, J. E. Lee, H. S. Kim [et al.] // Ann Neurol. 2012. Vol. 72, Issue 1. Р. 32—40. DOI: https://doi.org/10.1002/ana.23612.
  31. Safety and clinical effects of mesenchymal stem cells secreting neurotrophic factor transplantation in patients with amyotrophic lateral sclerosis: results of phase 1/2 and 2a clinical trials / P. Petrou, Y. Gothelf, Z. Argov [et al.] // JAMA Neurol. 2016. 73 (3). Р. 337—344. DOI: https://doi.org/10.1001/jamaneurol.2015.4321.
  32. Immunomodulation and neuroprotection with mesenchymal bone marrow stem cells (MSCs): a proposed treatment for multiple sclerosis and other neuroimmunological/neurodegenerative diseases / D. Karussis, I. Kassis, B.    Kurkalli, S. Slavin // J Neurol Sci. 2008. Vol. 265, Issues 1–2. Р. 131—135. DOI: https://doi.org/10.1016/j.jns.2007.05.005.
  33. NurOwn, phase 2, randomized, clinical trial in patients with ALS: safety, clinical, biomarker results / Berry J. D., Cudkowicz M. E., Windebank A. J [et al.] // Neurology. 2019. 93 (24): e2294-e2305. DOI: https://doi.org/10.1212/WNL.0000000000008620.
  34. Transplantation of spinal cord-derived neural stem cells for ALS: analysis of phase 1 and 2 trials / J. D. Glass, V. S. Hertzberg, N. M. Boulis [et al.] // Neurology. 2016. 87 (4). Р. 392—400. DOI: https://doi.org/10.1212/WNL.0000000000002889.
  35. Phase I trial of intrathecal mesenchymal stem cellderived neural progenitors in progressive multiple sclerosis / V. K. Harris, J. Stark, T. Vyshkina [et al.] // EBioMedicine. 2018. No. 29. Р. 23—30. DOI: https://doi.org/10.1016/j.ebiom.2018.02.002.
  36. Autologous mesenchymal stem cells for the treatment of secondary progressive multiple sclerosis: an open-label phase 2a proof-of-concept study / P. M. Connick, C. Crawley, D. J. Webber [et al.] // Lancet Neurol. 2012. Vol. 11, Issue 2. Р. 150—156. DOI: https://doi.org/10.1016/S1474-4422(11)70305-2.
  37. Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: a triple blinded, placebo controlled, randomized phase I/II safety and feasibility study / O. Fernandez, G. Izquierdo, V. Fernandez [et al.] // PLoS ONE. 2018. 13 (5): e0195891. DOI: https://doi.org/10.1371/journal.pone.0195891.
  38. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis / S. Llufriu, M. Sepulveda, Y. Blanco [et al.] // PLoS ONE. 2014. 9 (12): e113936. DOI: https://doi.org/10.1371/journal.pone.0113936.
  39. Human placenta-derived cells (PDA-001) for the treatment of adults with multiple sclerosis: a randomized, placebocontrolled, multiple-dose study / F.   Lublin, J.  D.  Bowen, J. Huddlestone [et al.] // Mult Scler Relat Disord. 2014. Vol. 3, Issue 6. Р. 696—704. DOI: https://doi.org/10.1016/j.msard.2014.08.002.
  40. Beneficial effects of autologous mesenchymal stem cell transplantation in active progressive multiple sclerosis / P. Petrou, I.  Kassis, N.  Levin [et  ]  // Brain.  2020. 143  (12). Р. 3574—3588. DOI: https://doi.org/10.1093/brain/awaa333.
  41. Voloshina N. P., Vasilovskiy V. V., Mikulinskiy Yu. E., Schegelskaya E. A. Autoterapiya kletkami stromyi kostnogo mozga (KSKM), indutsirovannyimi v nervnyie, bolnyih s hronicheskimi zabolevaniyami TsNS (rasseyannyiy skleroz, bolezn Parkinsona). Ukrainskyi neirokhirurhichnyi zhurnal. 2003. No. 3. URL: https://cyberleninka.ru/article/n/autoterapiya-kletkamistromy-kostnogo-mozga-indutsirovannymi-v-nervnye-bolnyhs-hronicheskimi-zabolevaniyami-tsns-rasseyannyy-skleroz.
  42. Mesenchymal stem cells are short-lived and do not migrate beyond the lungs after intravenous infusion / E. Eggenhofer, V. Benseler, A. Kroemer [et al.] // Front Immunol. 2012. Vol. 3: 297. DOI: https://doi.org/10.3389/fimmu.2012.00297.
  43. Voloshyna N. P., Vasylovskyi V. V., Mikulynskyi Yu. Yu., Shchehelska O. A. Patent UA 68711 A. «Sposib likuvannia khvorykh na rozsiianyi skleroz» vid 02.10.2003. Kyiv. Ukrpatent.
  44. Voloshina N. P., Vasilovskiy V. V. Eticheskie voprosyi v lechenii bolnyih rasseyannyim sklerozom (autoterapiya stromalnyimi kletkami kostnogo mozga, indutsirovannyimi v nervnyie). Kultura narodov Prichernomorya. 2004. No. 56. T. 2. R. 185—186.