The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: An open-label pre-test: Post-test study with blinded outcome assessments

Trials

Volumn 12, Issue , 2011, Pages

  Connick, Peter ^a,c   Kolappan, Madhan ^b   Patani, Rickie ^a   Scott, Michael A ^b   Crawley, Charles ^b   He, Xiao Ling ^a   Richardson, Karen ^b   Barber, Kelly ^b   Webber, Daniel J ^a   Wheeler Kingshott, Claudia A M ^b   Tozer, Daniel J ^b   Samson, Rebecca S ^b   Thomas, David L ^d   Du, Ming Qing ^a   Luan, Shi L ^a   Michell, Andrew W ^a   Altmann, Daniel R ^e   Thompson, Alan J ^d   Miller, David H ^b   Compston, Alastair ^a   Chandran, Siddharthan ^a,f   more..

^a UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c ADDENBROOKE S HOSPITAL   (United Kingdom)

^d UNIVERSITY COLLEGE LONDON   (United Kingdom)

^e LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^f UNIVERSITY OF EDINBURGH   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CHLORPHENIRAMINE; HYDROCORTISONE; METOCLOPRAMIDE;

ADULT; ARTICLE; BRAIN; CELL CULTURE; CELL ISOLATION; CLINICAL ARTICLE; CLINICAL PROTOCOL; DIFFUSION TENSOR IMAGING; DISEASE COURSE; ETHICS; FEASIBILITY STUDY; FEMALE; FEVER; HUMAN; IN VITRO STUDY; MALE; MESENCHYMAL STEM CELL; MULTIPLE SCLEROSIS; NEUROPROTECTION; NUCLEAR MAGNETIC RESONANCE IMAGING; OPTIC NERVE; OPTIC NEURITIS; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRETEST POSTTEST DESIGN; PRURITUS; RASH; SAFETY; STEM CELL TRANSPLANTATION; STUDY DESIGN; VISUAL SYSTEM; AUTOTRANSPLANTATION; CELL PROLIFERATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISABILITY; MESENCHYMAL STEM CELL TRANSPLANTATION; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; PHYSIOLOGY; RISK ASSESSMENT; TIME; TREATMENT OUTCOME; UNITED KINGDOM;

ADULT; CELL PROLIFERATION; CELLS, CULTURED; DISABILITY EVALUATION; ENGLAND; FEASIBILITY STUDIES; FEMALE; HUMANS; MAGNETIC RESONANCE IMAGING; MALE; MESENCHYMAL STEM CELL TRANSPLANTATION; MESENCHYMAL STEM CELLS; MIDDLE AGED; MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE; RESEARCH DESIGN; RISK ASSESSMENT; TIME FACTORS; TRANSPLANTATION, AUTOLOGOUS; TREATMENT OUTCOME;

EID: 79952084861     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-62     Document Type: Article

References (29)

1. Compston DAS, Coles AJ. Multiple Sclerosis. Lancet 2008, 372:1502-1517. 10.1016/S0140-6736(08)61620-7, 18970977.
2. Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalbán X, Barkhof F, Radü EW, Bauer L, Dahms S, Lanius V, Pohl C, Sandbrink R, . BENEFIT Study Group Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet 2007, 370:389-97. 10.1016/S0140-6736(07)61194-5, 17679016, BENEFIT Study Group.
3. Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK. CAMMS223 Trial Investigators Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med 2008, 359:1786-801. 10.1056/NEJMoa0802670, 18946064, CAMMS223 Trial Investigators.
4. Rivera FJ, Couillard-Despres S, Pedre X, Ploetz S, Caioni M, Lois C, Bogdahn U, Aigner L. Mesenchymal stem cells instruct oligodendrogenic fate decision on adult neural stem cells. Stem Cells 2006, 24:2209-19. 10.1634/stemcells.2005-0614, 16763198.
5. Bai L, Lennon DP, Eaton V, Maier K, Caplan AI, Miller SD, Miller RH. Human bone marrow-derived mesenchymal stem cells induce Th2-polarized immune response and promote endogenous repair in animal models of multiple sclerosis. Glia 2009, 57:1192-203. 10.1002/glia.20841, 2706928, 19191336.
6. Zappia E, Casazza S, Pedemonte E, Benvenuto F, Bonanni I, Gerdoni E, Giunti D, Ceravolo A, Cazzanti F, Frassoni F, Mancardi G, Uccelli A. Mesenchymal stem cells ameliorate experimental autoimmune encephalomyelitis inducing T-cell anergy. Blood 2005, 106:1755-61. 10.1182/blood-2005-04-1496, 15905186.
7. Zhang J, Li Y, Chen J, Cui Y, Lu M, Elias SB, Mitchell JB, Hammill L, Vanguri P, Chopp M. Human bone marrow stromal cell treatment improves neurological functional recovery in EAE mice. Exp Neurol 2005, 195:16-26. 10.1016/j.expneurol.2005.03.018, 15904921.
8. Le Blanc K, Frassoni F, Ball L, Locatelli F, Roelofs H, Lewis I, Lanino E, Sundberg B, Bernardo ME, Remberger M, Dini G, Egeler RM, Bacigalupo A, Fibbe W, Ringdén O, . Developmental Committee of the European Group for Blood and Marrow Transplantation Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study. Lancet 2008, 371:1579-86. 10.1016/S0140-6736(08)60690-X, 18468541, Developmental Committee of the European Group for Blood and Marrow Transplantation.
9. Kapoor R. Neuroprotection in multiple sclerosis: therapeutic strategies and clinical trial design. Curr Opin Neurol 2006, 19:255-259. 10.1097/01.wco.0000227034.85576.16, 16702831.
10. Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science 1999, 284:143-7. 10.1126/science.284.5411.143, 10102814.
11. Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop DJ, Horwitz E. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy 2006, 8:315-7. 10.1080/14653240600855905, 16923606.
12. Johnson NA, Hamoudi RA, Ichimura K, Liu L, Pearson DM, Collins VP, Du MQ. Application of array CGH on archival formalin-fixed paraffin-embedded tissues including small numbers of microdissected cells. Lab Invest 2006, 86:968-78. 10.1038/labinvest.3700441, 2815849, 16751780.
13. Kolappan M, Henderson AP, Jenkins TM, Wheeler-Kingshott CA, Plant GT, Thompson AJ, Miller DH. Assessing structure and function of the afferent visual pathway in multiple sclerosis and associated optic neuritis. J Neurol 2009, 256:305-19. 10.1007/s00415-009-0123-z, 19296047.
14. Hickman SJ, Brex PA, Brierley CM, Silver NC, Barker GJ, Scolding NJ, Compston DA, Moseley IF, Plant GT, Miller DH. Detection of optic nerve atrophy following a single episode of unilateral optic neuritis by MRI using a fat-saturated short-echo fast FLAIR sequence. Neuroradiology 2001, 43:123-8. 10.1007/s002340000450, 11326556.
15. Wheeler-Kingshott CAM, Trip SA, Symms MR, Parker GJM, Barker GJ, Miller DH. In vivo diffusion tensor imaging of the human optic nerve: pilot study in normal controls. Magn. Reson. Med 2006, 56:446-51. 10.1002/mrm.20964, 16791864.
16. Cook PA, Bai Y, Nedjati-Gilani S, Seunarine KK, Hall MG, Parker GJ, Alexander DC. Camino: Open-Source Diffusion-MRI Reconstruction and Processing. Proceedings of the 14th Scientific Meeting of ISMRM, Seattle, WA, USA 2006, Abstract 2759.
17. Lee JH, Garwood M, Menon R, Adriany G, Andersen P, Truwit CL, Uǧurbil K. High contrast and fast three-dimensional magnetic resonance imaging at high fields. Magn Reson Med 1995, 34:308-12. 10.1002/mrm.1910340305, 7500867.
18. Deichmann R, Schwarzbauer C, Turner R. Optimisation of the 3D MDEFT sequence for anatomical brain imaging: technical implications at 1.5 and 3 T. Neuroimage 2004, 21:757-67. 10.1016/j.neuroimage.2003.09.062, 14980579.
19. Thomas DL, De Vita E, Deichmann R, Turner R, Ordidge RJ. 3D MDEFT imaging of the human brain at 4.7T with reduced sensitivity to RF inhomogeneity. Magn. Reson. Med 2005, 53:1452-1458. 10.1002/mrm.20482, 1633717, 15906308.
20. Smith SM, Zhang Y, Jenkinson M, Chen J, Matthews PM, Federico A, De Stefano N. Accurate, robust, and automated longitudinal and cross-sectional brain change analysis. Neuroimage 2002, 17:479-89. 10.1006/nimg.2002.1040, 12482100.
21. Friston KJ, Holmes AP, Worsley KJ, Poline JB, Frith CD, Frackowiak RSJ. Statistical parametric maps in functional imaging: A general linear approach. Human Brain Mapping 1995, 2:189-210.
22. Toosy AT, Hickman SJ, Miszkiel KA, Jones SJ, Plant GT, Altmann DR, Barker GJ, Miller DH, Thompson AJ. Adaptive cortical plasticity in higher visual areas after acute optic neuritis. Ann Neurol 2005, 57:622-33. 10.1002/ana.20448, 15852380.
23. Fog T, Linnemann F. The course of multiple sclerosis in 73 cases with computer-designed curves. Acta Neurol Scand 1970, 42(S19):9-11.
24. Patzold U, Pocklington PR. Course of multiple sclerosis: first results of a prospective study carried out of 102 MS patients from 1976 - 1980. Acta Neurol Scand 1982, 105:164-168.
25. Ingle GT, Stevenson VL, Miller DH, Thompson AJ. Primary progressive multiple sclerosis: a 5-year clinical and MR study. Brain 2003, 126:2528-2536. 10.1093/brain/awg261, 12902314.
26. Bonnate PL. Analysis of pretest-posttest designs. 2000, 10. CRC Press.
27. Hobart JC, Cano SJ, Zajicek JP, Thompson AJ. Rating scales as outcome measures for clinical trials in neurology: problems, solutions, and recommendations. Lancet Neurol 2007, 6:1094-105. 10.1016/S1474-4422(07)70290-9, 18031706.
28. Karussis D, Karageorgiou C, Vaknin-Dembinsky A, Gowda-Kurkalli B, Gomori JM, Kassis I, Bulte JW, Petrou P, Ben-Hur T, Abramsky O, Slavin S. Safety and immunological effects of mesenchymal stem cell transplantation in patients with multiple sclerosis and amyotrophic lateral sclerosis. Arch Neurol 2010, 67:1187-94. 10.1001/archneurol.2010.248, 3036569, 20937945.
29. Mohyeddin M, Yazdanbakhsh S, Lotfi J, Alimoghaddom K, Talebian F, Hooshmand F, Ghavamzadeh A, Nikbin B. Does mesenchymal stem cell therapy help multiple sclerosis patients? Report of a pilot study. Iran J Immunol 2007, 4:50-7.