Anderson-Erisman, Kim

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The SCI Research Front

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Anderson-Erisman, Kim

  1. 1. Frontiers in Spinal Cord Injury Therapies<br />Kim Anderson-Erisman, Ph.D.<br />Director of Education<br />The Miami Project to Cure Paralysis<br />University of Miami<br />July 12, 2011<br />
  2. 2. SCI in the USA<br />12,000 new injuries each year<br />232,000-316,000 living with SCI<br />81% males<br />Average age at injury is 40.7 years old<br /><ul><li>1,275,000 living with SCI
  3. 3. 61% males</li></ul>Model Systems for SCI<br />Chris & Dana Reeve Foundation<br />
  4. 4. Life Expectancy & Costs of SCI<br />
  5. 5. Types of SCI<br />
  6. 6. What is Spinal Cord Injury (SCI)?<br />Normal<br />Solid cord damage<br />Contusion w/ cyst<br />Laceration<br />Massive Compression<br />Norenberg et al., 2004. J. Neurotrauma. 21:429-440<br />
  7. 7. Inside the spinal cord<br />Inhibitory scar<br />Cut axons<br />Primary damage<br />Secondary damage<br />Cell death<br />McDonald , 1999. Sci. Amer. 281:64-73<br />
  8. 8. What happens functionally?<br /><ul><li>Motor
  9. 9. Legs
  10. 10. Arms/hands
  11. 11. Abdominal/Intercostal
  12. 12. Sphincters
  13. 13. Sensory
  14. 14. Light touch
  15. 15. Pin prick
  16. 16. Temperature
  17. 17. Spontaneous pain
  18. 18. Autonomic
  19. 19. Cardiovascular
  20. 20. Temperature regulation
  21. 21. Bladder
  22. 22. Bowel
  23. 23. Sexual</li></li></ul><li>Functional Recovery Priorities<br />Anderson, 2004. J. Neurotrauma. 21:1371-1383.<br />
  24. 24. Repair Strategies<br />Neutralize inhibitory scar<br />Induce axon regeneration<br />Prevent<br />secondary damage<br />Cell replacement<br />McDonald , 1999. Sci. Amer. 281:64-73<br />
  25. 25. Clinical Trials<br />COST<br />The majority of academic research is in the “Pre-Discovery” and “Discovery” phases.<br />30 days<br />
  26. 26. Neuroprotection <br /><ul><li>Pharmacologic interventions
  27. 27. Riluzole (NACTN)
  28. 28. Already FDA-approved for Lou Gehrig’s disease (ALS)
  29. 29. Phase I safety study; multi-center
  30. 30. Within 12 hrs post-injury, continue for 14 days; Oral
  31. 31. Minocycline (University of Calgary)
  32. 32. Phase I/II safety & preliminary efficacy; single center
  33. 33. Within 12 hrs post-injury, continue for 7 days; IV
  34. 34. Cethrin (BA-210; Alseres Pharmaceuticals)
  35. 35. Previous Phase I & II trials
  36. 36. Within 72 hrs post-injury; intraoperative epidural delivery</li></li></ul><li>Non-pharmacologic<br />Cerebrospinal fluid drainage<br />University of British Columbia<br />Lumbar puncture with epidural catheter for 72 hrs<br />Target - increase oxygen delivery to the spinal cord<br />Therapeutic hypothermia<br />The Miami Project/University of Miami <br />Intravascular catheter, lower temperature to 33°C<br />Target – inflammation and free radicals<br />Phase II multi-center trial in development<br />Neuroprotection cont’d<br />Levi et al., 2009<br />
  37. 37. <ul><li>Human embryonic stem cells
  38. 38. Geron Corp.; multi-center
  39. 39. Phase I safety study of GRNOPC1
  40. 40. Human embryonic stem cell line pre-differentiated into oligodendrocyte progenitor cells
  41. 41. Targeting remyelination of demyelinated axons to restore conduction
  42. 42. Complete thoracic spinal cord injury
  43. 43. Within 14 days of injury
  44. 44. Intraspinal injection; single dose
  45. 45. Temporary immunosuppression
  46. 46. Follow for 1 year intensely, then 15 years long-term</li></ul>Cell-based<br />Keirstead et al., 2005 J. Neurosci. 29(19):4694<br />
  47. 47. <ul><li>Human fetal CNS stem cells
  48. 48. StemCells, Inc.; single center
  49. 49. Phase I/II safety & preliminary effiacy of HuCNS-SC
  50. 50. Human neural stem cells derived from fetal brain tissue
  51. 51. Targeting remyelination and possibly neuronal cell replacement
  52. 52. Complete and incomplete thoracic SCI (3 cohorts)
  53. 53. Within 3 to 12 months post-injury
  54. 54. Intraspinal injection
  55. 55. Temporary immunosuppression
  56. 56. Follow for 1 year intensely, then 4 years long-term</li></ul>Cell-based cont’d<br />
  57. 57. <ul><li>Human bone marrow progenitor cells
  58. 58. Memorial Hermann Healthcare System/ UT Health Science Center; single center
  59. 59. Phase I safety study of huBMPCs
  60. 60. Harvested from bone marrow
  61. 61. Target not define, possibly a growth supportive role by releasing neurotrophic chemicals
  62. 62. Complete and incomplete SCI; 1-15 years of age
  63. 63. Within 6 months to 4 years post-injury
  64. 64. Intravenous injection; single dose
  65. 65. Autologous (no immunosuppression)
  66. 66. Follow for 6 months, then 1.5 years long-term</li></ul>Cell-based cont’d<br />
  67. 67. Human Schwann cells<br />The Miami Project/University of Miami<br />Preparing IND for proposed Phase I safety study<br />Harvested from sural nerve biopsy<br />Targeting remyelination and neurotrophic support<br />Complete, thoracic SCI<br />Within 5 days post-injury<br />Intraspinal injection; single dose<br />Autologous (no immunosupression)<br />Follow for 1 year intensely, then TBD long-term<br />Cell based cont’d<br />
  68. 68. AT1355<br />Novartis; multi-center in US, Canada, and Europe<br />Phase I safety study of Nogo antibody AT1355<br />Human antibody to Nogo protein<br />Targeting nerve fiber sprouting indirectly by neutralizing the inhibitory effects of damaged myelin<br />Complete SCI, C5-T12<br />Within 4 to 14 or 28 days post-injury<br />Intrathecal infusion; 6 dose cohorts<br />Follow for 1 year<br />Neutralize inhibition<br />Schwab 2010 Nat. Rev. Neurosci. 11:799-811<br />
  69. 69. Axonal Regeneration<br />
  70. 70. Rehabilitation <br /><ul><li>Physical Activity Guidelines for People With Spinal Cord Injury (SCI)
  71. 71. Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial
  72. 72. SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury
  73. 73. SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury
  74. 74. Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury
  75. 75. Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
  76. 76. Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury
  77. 77. Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury</li></li></ul><li>Rehabilitation <br /><ul><li>Restoration of Upper Limb Function in Individuals With Sub-Acute Spinal Cord Injury
  78. 78. The Effect of an Exercise Program on Physical Function After a Spinal Cord Injury
  79. 79. The Effect of Locomotor Training on Children With Incomplete Spinal Cord Injuries
  80. 80. Enhancing Walking in People With Incomplete Spinal Cord Injury: a Pilot Study
  81. 81. The Effects of Passive Gait Training in Complete Motor Spinal Cord Injury (SCI)
  82. 82. Improving Hand and Arm Function After Spinal Cord Injury (SCI)
  83. 83. Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury
  84. 84. Effects of Breathing and Walking Treatments on Recovery Post-Spinal Cord Injury</li></li></ul><li><ul><li>Hand Function for Tetraplegia
  85. 85. The Effects of Two Functional Electrical Stimulation Cycling Paradigms
  86. 86. Effects of an Early Wheelchair Reconditioning Program on Functional Independence in spinal cord-injured Individuals
  87. 87. FES Therapy: Restoring Voluntary Grasping Function in Chronic SCI
  88. 88. Effects of Exercise in People With Tetraplegia
  89. 89. Effects of Exercise in People With Paraplegia
  90. 90. Functional and Physiological Responses to Lokomat Therapy (Pilot Study)</li></ul>Rehabilitation <br />
  91. 91. Ultimate “Cure”<br />Neuroprotective intervention early<br />Cell replacement therapy (single or multiple types of cells)<br />Axonal regeneration therapies<br />Muscle conditioning and bone density maintenance throughout<br />Specific motor training paradigms<br />
  92. 92. Questions <br />

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