First human implantation of a bioresorbable polymer scaffold for acute traumatic spinal cord injury: A clinical pilot study for safety and feasibility

Neurosurgery

Volumn 79, Issue 2, 2016, Pages E305-E312

  Theodore, Nicholas ^a   Hlubek, Randall ^a   Danielson, Jill ^a   Neff, Kristin ^b   Vaickus, Lou ^b,c   Ulich, Thomas R ^b   Ropper, Alexander E ^a  

^a BARROW NEUROLOGICAL INSTITUTE   (United States)

^b InVivo Therapeutics Corporation   (United States)

^c Akta Pharmaceutical Development   (United States)

Author keywords

Myelotomy; Scaffold; Spinal cord injury; Spinal cord rehabilitation

Indexed keywords

MOLECULAR SCAFFOLD; NORADRENALIN; POLYMER; VANCOMYCIN;

ADULT; ARTICLE; CASE REPORT; COMPUTER ASSISTED TOMOGRAPHY; CORDOTOMY; FEASIBILITY STUDY; FOLLOW UP; FRACTURE DISLOCATION; HUMAN; LAMINECTOMY; MALE; NEUROLOGIC EXAMINATION; NEUROPATHIC PAIN; NUCLEAR MAGNETIC RESONANCE IMAGING; OPEN REDUCTION; PARALYSIS; PATIENT SAFETY; PEDICLE SCREW; PHYSIOTHERAPY; PILOT STUDY; POSTOPERATIVE PAIN; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; SPINAL CORD COMPRESSION; SPINAL CORD INJURY; SPINAL CORD LESION; TRAFFIC ACCIDENT; TREATMENT OUTCOME; URINARY TRACT INFECTION; BIODEGRADABLE IMPLANT; DECOMPRESSION SURGERY; INJURIES; SPINAL CORD INJURIES; SPINAL FRACTURES; THORACIC VERTEBRA; TISSUE SCAFFOLD;

ABSORBABLE IMPLANTS; ADULT; DECOMPRESSION, SURGICAL; FEASIBILITY STUDIES; HUMANS; MALE; NEUROLOGIC EXAMINATION; PILOT PROJECTS; POLYMERS; SPINAL CORD INJURIES; SPINAL FRACTURES; THORACIC VERTEBRAE; TISSUE SCAFFOLDS; TREATMENT OUTCOME;

EID: 84975147894     PISSN: 0148396X     EISSN: 15244040     Source Type: Journal    
DOI: 10.1227/NEU.0000000000001283     Document Type: Article

References (13)

1. Tator CH, Hashimoto R, Raich A, et al. Translational potential of preclinical trials of neuroprotection through pharmacotherapy for spinal cord injury. J Neurosurg Spine. 2012;17(1 Suppl):157-229.
2. Harrop JS, Hashimoto R, Norvell D, et al. Evaluation of clinical experience using cell-based therapies in patients with spinal cord injury: a systematic review. J Neurosurg Spine. 2012;17(1 Suppl):230-246.
3. Pritchard CD, Slotkin JR, Yu D, et al. Establishing a model spinal cord injury in the African green monkey for the preclinical evaluation of biodegradable polymer scaffolds seeded with human neural stem cells. J Neurosci Methods. 2010;188(2): 258-269.
4. Teng YD, Lavik EB, Qu X, et al. Functional recovery following traumatic spinal cord injury mediated by a unique polymer scaffold seeded with neural stem cells. Proc Natl Acad Sci USA. 2002;99(5):3024-3029.
5. Hadley MN, Walters BC, Grabb PA, et al. Guidelines for the Managements of Acute Cervical Spine and Spinal Cord Injuries. Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons and the Congress of Neurological Surgeons. 2001. Available at: http://www.aans. org/en/education%20and%20meetings/^/media/files/education%20and% 20meetingf/clinical%20guidelines/traumaguidelines.ashx. Accessed July 2, 2015.
6. Marino RJ, Ditunno JF Jr, Donovan WH, Maynard F Jr. Neurologic recovery after traumatic spinal cord injury: data from the Model Spinal Cord Injury Systems. Arch Phys Med Rehabil. 1999;80(11):1391-1396.
7. Zariffa J, Kramer JL, Fawcett JW, et al. Characterization of neurological recovery following traumatic sensorimotor complete thoracic spinal cord injury. Spinal Cord. 2011;49(3):463-471.
8. Martirosyan NL, Kalani MY, Bichard WD, et al. Cerebrospinal fluid drainage and induced hypertension improve spinal cord perfusion after acute spinal cord injury in pigs. Neurosurgery. 2015;76(4):461-468. discussion 468-469.
9. Harrop JS, Naroji S, Maltenfort MG, et al. Neurologic improvement after thoracic, thoracolumbar, and lumbar spinal cord (conus medullaris) injuries. Spine (Phila Pa 1976). 2011;36(1):21-25.
10. Allen AR. Surgery of experimental lesion of spinal cord equivalent to crush injury of fracture dislocation of spinal column. JAMA. 1911;LVII(11):878-880.
11. Allen AR. Remarks on the histopathological changes in the spinal cord due to impact. An experimental study. J Nerv Ment Dis. 1914;41:141-147.
12. Hu AM, Li JJ, Sun W, et al. Myelotomy reduces spinal cord edema and inhibits aquaporin-4 and aquaporin-9 expression in rats with spinal cord injury. Spinal Cord. 2015;53(2):98-102.
13. Thompson JE. Pathological changes, occurring in the spinal cord, following fracture dislocation of the Vertebrae. Ann Surg. 1923;78(2):260-293.