Table 2. Clinical trials to enhance outcomes after spinal cord injury (SCI).
| Intervention RCTs* | Outcome | Confounds |
|---|---|---|
| Methylprednisolone (95) | Motor gains small; side effects greater with 48-h infusion | Design and statistical issues; limited impact of preventing lipid peroxidation |
| GM-1 ganglioside (96) | No better than steroid | Design, control, and statistical issues |
| 4-aminopyridine (fampridine) (92) | Improves axonal conduction to modestly increase strength or lessen fatigability with repeated movements | Plugs potassium channels in partially demyelinated fibers; in Phase 3 trial with 150 subjects for spasticity, bladder, and motor outcomes (Acorda Therapeutics, Hawthorne, NY) |
| BWSTT* for walking | Nonrandomized trials show value for poor walkers | High manpower and experience needed by therapists |
| Robotic- and FES*-assisted BWSTT | Robot-assistive stepper may be more practical than manual training for patients with no motor function; design ought to include proprioceptive/torque feedback | |
| SAFETY TRIALS FOR CHRONIC SCI (http://carecure.atinfopop.com; no peer-reviewed reports available) | ||
| Fetal tissue in cord syrinx | Cell plug persists without adverse reaction; no clear functional gains | Not sociopolitically viable in United States |
| Human fetal stem cells injected into lesion | Oral reports from Beijing and Moscow suggest no efficacy | No formal report of Phase 1/2 trials |
| Fetal OEGs* injected into cord | Report from Beijing in first 150 subjects and from Lisbon pending | Clinical assessments and outcome measures unclear |
| Fetal pig embryo cells cultured to become oligodendrocytes | Phase 1 trial not yet reported (Diacrin Inc., Charlestown, MA) | No cells found in one autopsy |
| Autologous monocytes activated against skin and injected into cord below lesion | Some sensorimotor gains in Phase 1 trial by oral report | Phase 2 trial of immune strategy pending (Proneuron Biotechnologies, Rehovat, Israel) |
| Peripheral nerve bridge with neurotrophins | Oral reports from Taiwan (H Cheng, http://www.nature.com/nsu/nsu_pf/030512-12.html) | Technical difficulty and could reinjure cord |
*
RCT, randomized clinical trial; BWSTT, body weight–supported treadmill training; FES, functional electrical stimulation; OEG, olfactory ensheathing glial cells.