faculty do not endorse this procedure and at this time would not advise individuals to undergo this surgical transplantation strategy. While some people with SCI will view current experimental procedures abroad as their only hope, by participating they may be putting themselves at risk as well as potentially disqualifying themselves from participating in future more promising and well-designed clinical trials.
Presently, Dr. Huang's work would meet the standard for clinical trials set by the FDA or European regulatory agencies. His work should therefore be viewed as a series of clinical treatments rather than a clinical trial. This is a very important distinction since a clinical trial would allow for definitive conclusions while a treatment series cannot. To properly assess this treatment, a more rigorous clinical trial is required; one that includes specific outcome measures and comparisons to a control group. It would also include accurate documentation of whether adverse effects occur over the long-term.
While there may be disagreement among clinicians and researchers as to when and which promising pre-clinical strategies should be advanced to clinical trials, it is important to emphasize that scientists all over the world are coming together to develop valid clinical trial guidelines for treatments targeting SCI. ICCP supported and funded the International Clinical Trials Workshop on SCI in Vancouver that brought a varied team of researchers and clinicians together to discuss progress in clinical trials and the complexities involved in effective clinical trial design. A report of this meeting was peer-reviewed and published by J. Steeves, J. Fawcett, and M. Tuszynski in 2004 (Spinal Cord 42:591-597). As a result of this meeting, an international advisory panel was created to develop more detailed guidelines on how to conduct future SCI clinical trials in the most accurate and effective manner.
It is hoped that further information coming from individual clinical studies as well as continued research into this into this important and exciting field will stimulate well-controlled multi-center trials utilizing the appropriate safety and outcome measures. Well-designed FDA-approved clinical trials will minimize the chances of a procedure being harmful to the patient and will maximize the opportunity to document long-lasting improvements in the future. Only through a strategy such as this can evidence-based medicine be advanced, and the safest and most effective treatments be advanced to the clinic and applied.
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