Related Experiment Videos
The Sygen multicenter acute spinal cord injury study.
F H Geisler1, W P Coleman, G Grieco
1Medical Group, S.C., Chicago Institute of Neurosurgery and Neuroresearch, 2515 North Clark Street, Suite 800, Chicago, Illinois 60614, USA. fgeisler@concentric.net
Spine
|January 24, 2002
Summary
Sygen showed potential benefits for spinal cord injury patients, particularly those with severe injuries. Further research is needed to confirm efficacy in acute spinal cord injury treatment.
Area of Science:
- Neuroscience
- Clinical Pharmacology
- Regenerative Medicine
Background:
- Previous single-center trial indicated Sygen improved marked recovery in acute spinal cord injury (SCI) patients.
- Limited data necessitated further investigation into Sygen's efficacy and safety in a larger, multicenter setting.
Purpose of the Study:
- To evaluate the efficacy and safety of Sygen in patients experiencing acute spinal cord injury.
- To determine optimal dosing and patient subgroups that may benefit from Sygen treatment.
Main Methods:
- Conducted a randomized, double-blind, sequential, multicenter clinical trial comparing two doses of Sygen against a placebo.
- Employed standard clinical trial methodologies for data collection and analysis.
Main Results:
- The primary efficacy analysis across all patients at the prespecified endpoint was negative.
- Significant positive effects of Sygen were observed in the primary outcome variable (marked recovery) at week 8 and in the time to achieve marked recovery.
- A consistent and significant effect favoring Sygen was noted in non-operated patients through week 26, with trends favoring Sygen in motor scores, sensory function, and autonomic functions.
Conclusions:
- Despite a negative primary efficacy analysis, Sygen demonstrates a potential benefit in treating severe spinal cord injury.
- Evidence suggests Sygen may be more effective in less severely injured patients and non-operated individuals.