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2004 Directors' Summary Synopsis
INTERNATIONAL COOPERATION TO ACCELERATE MOVE TO CLINICAL TRIALS
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The Miami Project is involved on an international level to move investigations into clinical trial and to reach the goal of truly effective and safe treatments to cure paralysis. Current clinical procedures now available in countries outside of the United States are showing some promise as improvements in some functions have been reported. None of the procedures, however, have been shown to restore significant walking function.
This year, representatives from The Miami Project participated in international discussions regarding moving treatment strategies for SCI to clinical trial. Drs. Eva Widerstrom-Noga and neurosurgeon Dr. James Guest attended the Clinical Trials Workshop sponsored by the International Campaign for Cures of spinal cord Paralysis (ICCP.) This workshop established an international forum to discuss the design and conduct of SCI trials. Questions discussed were: What are the characteristics of a well-controlled clinical trial for spinal cord injury repair? What type of evidence from animal experiments should be required before initiating a trial in humans? How should results be measured? Are we at a point where experimental procedures should be translated to humans? As a result of the meeting, an international advisory panel was created to continue developing more detailed guidelines to direct spinal cord injury clinical trials in the most accurate, safe and effective manner. Dr. James Guest was invited to and will serve on this advisory panel.
Miami Project Researchers Visit China
The Clinical Trials Workshop also allowed researchers who are currently conducting clinical trials to present their experiences to this international community. Drs. Widerstrom-Noga and Guest had the opportunity to hear of the status of clinical trials underway in China, Brazil, France, Australia, Israel, Portugal and the United States. Of the many interesting studies presented at the workshop, the work of Dr. Hongyun Huang from China was notable because of the large number of patients that have undergone his transplantation of olfactory bulb-derived fetal cells. Olfactory ensheathing glia have been shown by Miami Project researchers and others to promote regeneration in experimental spinal cord injury.
Dr. Huang and his patients are reporting some improvements in sensory function within two weeks of the procedure. Because of the heightened interest on the part of scientists and patients, and the desire to evaluate the scientific merit of Dr. Huang’s procedure, The Miami Project established direct communication with Dr. Huang inviting him to present his unpublished findings to The Miami Project scientific team.
Dr. Huang’s study, in the opinion of Miami Project researchers, does not meet the design standards that would allow definitive results to be obtained. Better follow-up and careful documentation of outcomes are needed in order to understand the significance of the functional improvements described.
In an effort to obtain better scientific data, The Miami Project has continued communicating with Dr. Huang. He has shown a willingness to cooperate with our researchers and in July, Dr. James Guest and rehabilitation colleague Dr. Tie Qian traveled to China to observe the procedure first hand. After witnessing the transplantation procedures and the collection of data from patients undergoing it, they have concluded that the anecdotal nature of the study design leaves more questions than answers. Further study will be required to accurately assess and document patient’s improvements. Also, more work is needed to fully understand the types of cells being transplanted and their long-term safety.
While Dr. Huang’s procedure would not meet the research standards that apply in the U.S., The Miami Project has plans to continue its relationship with Dr. Huang and is committed to acquiring the necessary knowledge for the development of truly effective treatments. |
