10-07-08(10:09:25)

Authors:

Henrich Cheng 1,2,3,4,5,6,7
Wen-Cheng Huang 1,2,3
Wu-Jau Ching 1,2,3
Yun-An Tsai 1,3

Institutions:

1.Center for Neural Regeneration, 2. Dept. of Neurosurgery, 3. Taipei Veterans General Hospital, 4.Dept. and Inst. of Pharmacology, 5. Brain Research Center, 6. School of Medicine, 7. National Yang-Ming University

Title of abstract : Repair of the Chronic Spinal Cord Injury: Result of Phase II Clinical Trial

Abstract text:

Object. The aim of this study was to assess functional outcomes of nerve repair using acidic fibroblast growth factor (FGF) in patients with cervical spinal cord injury (SCI).

Methods. Sixty patients who had cervical or thoracic SCI for longer than 2 months were included in pre- and postoperative assessments of their neurological function. The assessments included evaluating activities of daily living, associated functional ability, and degree of spasticity, motor power, sensation, and pain perception. After the first set of assessments, the authors repaired the injured segment of the spinal cord using a total laminectomy followed by the application of fibrin glue containing acidic FGF. Clinical evaluations were conducted 1, 2, 3, 4, 5, 6 and 12 months after the surgery. Preoperative versus postoperative differences in injury severity and grading of motor power, sensory scores, ASIA impairment scale, motor and sensory levels, as well as neurological level were calculated using the Wilcoxon signed-rank test; while preoperative versus postoperative differences in the aspects of improvement, no change, and worsen were computed using McNemar test.

Results. The preoperative degree of injury severity, as measured using the American Spinal Injury Association (ASIA) scoring system in the cervical group, showed that preoperative motor (27.6±15.55 vs 35.5±19.99), pinprick (56.3±23.36 vs 61.9±24.47), and light touch scores (55.8±24.89 vs 58.4±26.49) were significantly lower than the respective postoperative scores measured 12 months after surgery (p = 0.0001, 0.0043, and 0.0663, respectively). On the other hand, in the thoracic group, the data showed that preoperative motor (56.8±9.21 vs 59.8±9.64), pinprick (78.2±14.72 vs 81.8±16.02), and light touch scores (75.7±15.65 vs 78.2±15.76) were also significantly lower than the respective postoperative scores measured 12 months after surgery (p = 0.0001, 0.0002, and 0.0040, respectively). Furthermore, the improvement of neurological levels in cervical group can extend at least 1 unit, with right side (5.17±1.53 vs 6.57±4.01, p = 0.0263), left side (5.20±1.61 vs 6.50±3.90, p = 0.0378). As for thoracic group, the improvement of neurological levels can extend at least 1.5 units, with right side (11.97±5.49 vs 14.83±6.28, p = 0.0027), left side (13.10±5.93 vs 14.87±6.31, p = 0.0233).

Conclusions. Based on the significant difference in ASIA motor and sensory scale scores between the preoperative status and the 12-month postoperative follow-up, this novel nerve repair strategy of using acidic FGF may have a beneficial role.


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