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?
These were a few of the questions addressed at the International Campaign for Cures of spinal cord Paralysis (ICCP) Clinical Trials Workshop that took place in February 2004. Gathering in Vancouver, Canada, neuroscientists, clinicians and people with SCI from all over the world met to continue discussions and coordination of efforts to translate promising pre-clinical research to human trials. The Vancouver workshop was a follow-up to a similar workshop sponsored by the National Institute of Neurological Disorders and Stroke a year ago. See the February issue of The Connection and NINDS summary.
One of the purposes of the ICCP Clinical Trials Workshop was to establish an international forum to discuss the design and conduct of SCI trials. Another aim of the workshop was to allow researchers who are currently conducting clinical trials to present their experiences to this international community. Participants were briefed on the status of trials underway in China, Brazil, France, Australia, Israel, Portugal and the United States. As a result, discussions about what constitutes a good clinical trial ensued and concerns arose about the inadequacy of current methods to measure results.
Among the participants from various countries were Miami Project principal investigators Eva Widerstrom-Noga, Ph.D. and James Guest, M.D., Ph.D. Upon their return to Miami, Drs. Widerstrom-Noga and Guest shared their impressions with the rest of The Miami Project team. Of the many interesting studies, the work of Dr. Hongyun Huang from China was notable due to the large number of patients that have undergone 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. For further information click here. Because of 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 has invited Dr. Huang to visit. During his next trip to the United States, Dr. Huang will visit to establish direct communication with our scientific team and share information about the procedure and his interpretation of the results.
Other important topics discussed at the ICCP Clinical Trials Workshop related to the need for better outcome measures and the lack of appropriate control subjects in some current clinical trials. “There was a consensus among the participants that current outcome measures are limited,” commented Dr. Widerstrom-Noga, “and the need to develop more sensitive tests to evaluate recovery will be important in the design of future clinical trials.” Summarizing the outcome of the workshop, Dr. Guest said “We thought the aims of the workshop were met, although it is just a beginning.” As international dialogues established at the ICCP Workshop continue, an international agreement of what constitutes a good clinical trial may be forthcoming and should lead to a coordinated international effort in conducting clinical trials. This is an important goal in order to ensure the safety of future clinical trials and improve the ability to make reliable conclusions about interventions.
While current clinical trials are promising because they may show improvements in some functions, none have been proven to restore significant walking function. Equally important to increasing the body of knowledge concerning the effectiveness of specific interventions is the thorough evaluation of safety in current and future studies. Thus, there is a need to build upon knowledge gained from current studies and to obtain additional scientific information for the development of better repair strategies. The Miami Project is involved on an international level to move investigations forward and to reach the goal of truly effective and safe treatments to cure paralysis.