clinical trials;
human clinical trial design and performance;
spinal cord injury;
translational research;
D O I:
10.1089/neu.2006.23.586
中图分类号:
R4 [临床医学];
学科分类号:
1002 ;
100602 ;
摘要:
Progress in promoting axonal plasticity and regeneration in animal models of spinal cord injury (SCI) has led to novel prospects for the initiation of human clinical trials in the near future. This review discusses a number of considerations in the path to translating a preclinical candidate from the laboratory to clinical testing. We will also briefly discuss issues associated with the design, performance, analysis, and reporting of human clinical trials in SCI. It is important, for both the medical community and the spinal cord injured community, that objective scientific and medical standards are adopted in the clinical translation of potentially promising, but as yet unproven, therapies for SCI.
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Dobkin, BH
Apple, D
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Apple, D
Barbeau, H
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Barbeau, H
Basso, M
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Basso, M
Behrman, A
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Behrman, A
Deforge, D
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Deforge, D
Ditunno, J
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Ditunno, J
Dudley, G
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Dudley, G
Elashoff, R
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Elashoff, R
Fugate, L
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Fugate, L
Harkema, S
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Harkema, S
Saulino, M
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Saulino, M
Scott, M
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Dobkin, BH
Apple, D
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Apple, D
Barbeau, H
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Barbeau, H
Basso, M
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Basso, M
Behrman, A
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Behrman, A
Deforge, D
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Deforge, D
Ditunno, J
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Ditunno, J
Dudley, G
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Dudley, G
Elashoff, R
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Elashoff, R
Fugate, L
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Fugate, L
Harkema, S
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Harkema, S
Saulino, M
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA
Saulino, M
Scott, M
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Reed Neurol Res Ctr, Dept Neurol, Neurol Rehabil & Res Program, Los Angeles, CA 90095 USA