Spinal cord injury clinical trials: Translational process, review of past and proposed acute trials with reference to recommended trial guidelines

Handbook of Clinical Neurology

Volumn 109, Issue , 2012, Pages 386-397

  Steeves, John ^a   Blight, Andrew ^b  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b ACORDA THERAPEUTICS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84867771482     PISSN: 00729752     EISSN: None     Source Type: Book Series    
DOI: 10.1016/B978-0-444-52137-8.00024-3     Document Type: Chapter

References (53)

1. AANS/CNS Pharmacological therapy after acute cervical spinal cord injury. Neurosurgery 2002, 50:S63-S72.
2. Alexander M.S., Anderson K., Biering-Sorensen F., et al. Outcome measures in spinal cord injury: recent assessments and recommendations for future directions. Spinal Cord 2009, 47:582-591.
3. Baptiste D.C., Fehlings M.G. Update on the treatment of spinal cord injury. Prog Brain Res 2007, 161:217-233.
4. Bose B., Osterholm J.L., Kalia M. Ganglioside-induced regeneration and reestablishment of axonal continuity in spinal cord-transected rats. Neurosci Lett 1986, 63:165-169.
5. Bracken M.B., Collins W.F., Freeman D.F., et al. Efficacy of methylprednisolone in acute spinal cord injury. JAMA 1984, 251:45-52.
6. Bracken M.B., Shepard M.J., Hellenbrand K.G., et al. Methylprednisolone and neurological function 1 year after spinal cord injury: results of the National Acute Spinal Cord Injury Study. J Neurosurg 1985, 63:704-713.
7. Bracken M.B., Shepard M.J., Collins W.F., et al. A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: results of the second national acute spinal cord injury study. N Engl J Med 1990, 322:1405-1411.
8. Bracken M.B., Shepard M.J., Collins W.F., et al. Methylprednisolone or naloxone treatment after acute spinal cord injury: 1-year follow-up data. J Neurosurg 1992, 76:23-31.
9. Bracken M.B., Shepard M.J., Holford T.R., et al. Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury. JAMA 1997, 277:1597-1604.
10. Bracken M.B., Shepard M.J., Holford T.R., et al. Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow-up. J Neurosurg 1998, 89:699-706.
11. Buchli A.D., Schwab M.E. Inhibition of Nogo: a key strategy to increase regeneration, plasticity and functional recovery of the lesioned central nervous system. Ann Med 2005, 37:556-567.
12. Bunge M.B. Novel combination strategies to repair the injured mammalian spinal cord. J Spinal Cord Med 2008, 31:262-269.
13. Cardenas D.D., Ditunno J., Graziani V., et al. Phase II trial of sustained-release fampridine in chronic spinal cord injury. Spinal Cord 2007, 45:158-168.
14. Constantini S., Young W. The effects of methylprednisolone and the ganglioside GM1 on acute spinal cord injury in rats. J Neurosurg 1994, 80:97-111.
15. Crossley N.A., Sena E., Goehler J., et al. Empirical evidence of bias in the design of experimental stroke studies: a metaepidemiologic approach. Stroke 2008, 39:929-934.
16. Dirnagl U. Bench to bedside: the quest for quality in experimental stroke research. J Cereb Blood Flow Metab 2006, 26:1465-1478.
17. Eck J.C., Nachtigall D., Humphreys S.C., et al. Questionnaire survey of spine surgeons on the use of methylprednisolone for acute spinal cord injury. Spine 2006, 31:E250-E253.
18. Fawcett J.W., Curt A., Steeves J.D., et al. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials. Spinal Cord 2007, 45:190-205.
19. Freund P., Schmidlin E., Wannier T., et al. Anti-Nogo-A antibody treatment promotes recovery of manual dexterity after unilateral cervical lesion in adult primates - re-examination and extension of behavioral data. Eur J Neurosci 2009, 29:983-996.
20. Furlan J.C., Fehlings M.G., Tator C.H., et al. Motor and sensory assessment of patients in clinical trials for pharmacological therapy of acute spinal cord injury: Psychometric properties of the ASIA standards. J Neurotrauma 2008, 25:1273-1301.
21. Gaviria M., Privat A., D'Arbigny P., et al. Neuroprotective effects of a novel NMDA antagonist, gacyclidine, after experimental contusive spinal cord injury in adult rats. Brain Res 2000, 874:200-209.
22. Geisler F.H., Dorsey F.C., Coleman W.P. Recovery of motor function after spinal-cord injury - a randomized, placebo controlled trial with GM-1 ganglioside. N Engl J Med 1991, 324:1829-1838.
23. Geisler F.H., Coleman W.P., Grieco G., et al. The Sygen multicenter acute spinal cord injury study. Spine 2001, 26:S87-S98.
24. Goodman A.D., Brown T.R., Krupp L.B., et al. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet 2009, 373:732-738.
25. Gorio A., Madaschi L., Di Stefano B., et al. Methylprednisolone neutralizes the beneficial effects of erythropoietin in experimental spinal cord injury. Proc Natl Acad Sci U S A 2005, 102:16379-16384.
26. Guest J.D., Hiester E.D., Bunge R.P. Demyelination and Schwann cell responses adjacent to injury epicenter cavities following chronic human spinal cord injury. Exp Neurol 2005, 192:384-393.
27. Hall E.D., Braughler J.M. Glucocorticoid mechanisms in acute spinal cord injury: a review and therapeutic rationale. Surg Neurol 1982, 18:320-327.
28. Hawryluk G.W., Rowland J., Kwon B.K., et al. Protection and repair of the injured spinal cord: a review of completed, ongoing, and planned clinical trials for acute spinal cord injury. Neurosurg Focus 2008, 25:E14.
29. Hurlbert R.J., Hamilton M.G. Methylprednisolone for acute spinal cord injury: 5-year practice reversal. Can J Neurol Sci 2008, 35:41-45.
30. Kang K.S., Kim S.W., Oh Y.H., et al. A 37-year-old spinal cord-injured female patient, transplanted of multipotent stem cells from human UC blood, with improved sensory perception and mobility, both functionally and morphologically: a case study. Cytotherapy 2005, 7:368-373.
31. Kramer J.K., Taylor P., Steeves J.D., et al. Dermatomal somatosensory evoked potentials and electrical perception thresholds during recovery from cervical spinal cord injury. Neurorehabil Neural Repair 2010, 24:309-317.
32. Lammertse D., Tuszynski M.H., Steeves J.D., et al. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial design. Spinal Cord 2007, 45:232-242.
33. Lammertse D., Dungan D., Dreisbach J., et al. Neuroimaging in traumatic spinal cord injury: an evidence-based review for clinical practice and research. J Spinal Cord Med 2007, 30:205-214.
34. Lord-Fontaine S., Yang F., Diep Q., et al. Local inhibition of Rho signaling by cell-permeable recombinant protein BA-210 prevents secondary damage and promotes functional recovery following acute spinal cord injury. J Neurotrauma 2008, 25:1309-1322.
35. Mackay-Sim A., Féron F., Cochrane J., et al. Autologous olfactory ensheathing cell transplantation in human paraplegia: a 3-year clinical trial. Brain 2008, 131:2376-2386.
36. Macleod M.R., Fisher M., O'Collins V., et al. Good laboratory practice: preventing introduction of bias at the bench. Stroke 2009, 40:e50-e52.
37. Matis G.K., Birbilis T. Erythropoietin in spinal cord injury. Eur Spine J 2008, 18:314-323.
38. Miller R.G., Mitchell J.D., Lyon M., et al. Riluzole for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND). Amyotroph Lateral Scler Other Motor Neuron Disord 2003, 4:191-206.
39. Otani K., Abe H., Kadoya S., et al. Beneficial effects of methylprednisolone sodium succinate in the treatment of acute spinal cord injury. Sekitsy Sekizui 1994, 7:633-647. (Japanese).
40. Peru R.L., Mandrycky N., Nait-Oumesmar B., et al. Paving the axonal highway: from stem cells to myelin repair. Stem Cell Rev 2008, 4:304-318.
41. Pinzon A., Marcillo A., Quintana A., et al. A re-assessment of minocycline as a neuroprotective agent in a rat spinal cord contusion model. Brain Res 2008, 1243:146-151.
42. Pointillart V., Petitjean M.E., Wiart L., et al. Pharmacological therapy of spinal cord injury during the acute phase. Spinal Cord 2000, 38:71-76.
43. Saito F., Nakatani T., Iwase M., et al. Spinal cord injury treatment with intrathecal autologous bone marrow stromal cell transplantation: the first clinical trial case report. J Trauma 2008, 64:53-59.
44. Sena E., van der Worp H.B., Howells D., et al. How can we improve the pre-clinical development of drugs for stroke?. Trends Neurosci 2007, 30:433-439.
45. Shi R., Blight A.R. The differential effects of low and high concentrations of 4-aminopyridine on axonal conduction in normal and injured spinal cord. Neuroscience 1997, 77:553-562.
46. Shi R., Kelly T.M., Blight A.R. Conduction block in acute and chronic spinal cord injury: different dose-response characteristics for reversal by 4-aminopyridine. Exp Neurol 1997, 148:495-501.
47. Shuaib A., Lees K.R., Lyden P., et al. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med 2007, 357:562-571.
48. Steeves J.D., Lammertse D., Curt A., et al. Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures. Spinal Cord 2007, 45:206-221.
49. Su H., Chu T.H., Wu W. Lithium enhances proliferation and neuronal differentiation of neural progenitor cells in vitro and after transplantation into the adult rat spinal cord. Exp Neurol 2007, 206:296-307.
50. Tadié M., Gaviria J.-F., Mathé P., et al. Early care and treatment with the neuroprotective drug gacyclidine in patients with acute spinal cord injury. RACHIS 2003, 15:363-376. (French translation).
51. Tator C.H. Review of treatment trials in human spinal cord injury: issues, difficulties, and recommendations. Neurosurg 2006, 59:957-982.
52. Tuszynski M.H., Steeves J.D., Fawcett J.W., et al. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial inclusion/exclusion criteria and ethics. Spinal Cord 2007, 45:222-231.
53. Vaquero J., Zurita M. Bone marrow stromal cells for spinal cord repair: a challenge for contemporary neurobiology. Histol Histopathol 2009, 24:107-116.