Biology Reference
In-Depth Information
2. CONCLUSION
It is impressive to see to which extent preclinical research has been
translated into clinical studies. Fifteen years ago, this was considered a goal
of the distant future. In order to realize properly conducted clinical trials,
clinical networks have been established which allow to perform multicenter
studies in a highly standardized fashion. As an example, within the European
Multicenter Study about Spinal Cord Injury (EMSCI) network, almost 20
SCI centers across Europe continuously train their staff to examine patients
according to internationally accepted protocols (ASIA Impairment Scale,
AIS; Walking Index for Spinal Cord Injury, WISCI; Spinal Cord Indepen-
dence Measure, SCIM; neurophysiological analysis) at defined time points
(
Curt, Schwab, & Dietz, 2004; Spiess et al., 2009
). Over time, an excellent
database combined with the definition of algorithms to allow error free data
acquisition and documentation as prerequisites for high-quality clinical
studies was established (
Schuld, Wiese, Hug, et al., 2012
). Therefore,
from a clinical point of view, the groundwork to run promising clinical
trials has been accomplished.
Despite this obvious progress, a proof of efficacy for any regenerative or
neuroprotective therapy to improve the natural course in SCI is still missing.
The critical appraisal of four different strategies translated into clinical studies
highlights two problems, which have to be accounted for in the experimen-
tal design and execution of future preclinical investigations: the clinical
translation of a drug/cell-based therapy is time consuming and very expen-
sive. The Novartis sponsored anti-Nogo-A antibody ATI355 trial took
5 years to recruit 51 patients. Two clinical trials were stopped prematurely
for financial reasons. In a disease condition with a rather low incidence in
industrialized countries such as SCI, the number of patients available for
clinical trials as well as financial resources is limited. Therefore, future pre-
clinical research activities have to identify effective drug/cell-based repair
strategies with a much higher predictive value that respective strategies will
succeed in human SCI. How can this be accomplished? In the future, a more
comprehensive preclinical investigation will depend on strong collaborative
efforts, both horizontally and vertically. Horizontally means that basic scien-
tists need to tightly collaborate, in order to share the burden of comprehen-
sive and rigid preclinical development (contusion SCI model, cervical SCI
model, large animal model, appropriate timing of treatment, replication
by an independent
laboratory,
relevant/robust
structural/functional
