|
When will there be a cure?
Why can't you test a cell transplant in a human now?
What do we have to lose?
What's taking the scientists so long? What's new (this month)?
Can anyone with spinal cord injury participate at The Miami Project?
How can I participate in research at The Miami Project?
Can I be put on a waiting list?
Do you collaborate with other centers? Who's ahead?
When will there be a cure? return to top At the present time, neither Miami Project researchers nor any other scientist can predict when human trials to promote regeneration in the spinal cord will begin. Researchers must wait for results in animal studies that provide significant proof of functional recovery to justify consideration of human trials. They will also need to demonstrate that the results can be repeated in independent laboratories and that cell transplantation works when tested in larger and chronically injured animals. This process takes time, but it is essential to develop reliable cure therapies that can be used with predictable beneficial results by many trained neurosurgeons on appropriate patients. Therefore, though early trials testing the safety of embryonic spinal tissues and Schwann cells are either underway or imminent, it is unlikely that cell transplantation therapies will be available for testing in the immediate future.
Why can't you test a cell transplant in a human now? What do we have to lose? return to top
There could be plenty to lose. First and foremost, any remaining spinal cord function, and even your life are at stake. Experimental cell grafting done before safety and effectiveness have been proven could result in undesirable side effects such as chronic pain or further paralysis. Ineffective surgeries may lead to scarring and/or tethering of the spinal cord, which can produce further loss of function. There are many other considerations, including the high cost of surgical procedures, their inherent risk, and the potential for post-operative complications. All of these must be balanced against prematurely testing a possible, but unproven, benefit of an experimental therapy.
What's taking the scientists so long? What's new (this month)? return to top
We understand that from the patient's perspective scientific progress is painstakingly slow. What many people forget is that only two decades ago, spinal cord regeneration was believed by most researchers to be unachievable. Since that time the scope of SCI research has literally exploded as SCI researchers and their colleagues in related fields have achieved important breakthroughs. These include a better understanding of spinal cord injuries themselves, drugs that can limit the amount of damage to the cord, the discovery of proteins that stimulate (or prevent) regeneration, and genetic-engineering and cell transplantation techniques that are being transformed into new therapeutic strategies. Investigators now are using multiple approaches and combination therapies to promote regeneration. They are testing a number of animal models of injury, and looking at a variety of treatments for SCI. Until these techniques are proven to work reliably, it would be unsafe to test them clinically (see above).
Monthly updates on particular research projects are not always possible, because each transplantation experiment may require months, or actually years to complete. We cannot report the findings from any study until the experiment is completed and the data show a clear positive or negative result. However, many such studies are ongoing at all times. Thus, we present lay summaries of new and exciting information as it becomes available (see Science Updates and annotations to Research Publications). It also is important to note that one step in testing new therapies is to conduct experiments with chronic injuries. Chronic experiments require months of post-injury and post-grafting time in which to evaluate recovery. Because there is an unprecedented level of SCI research going on around the world, there is also a unprecedented level of expectation from the public. As research findings become available, we strive to describe their meaning and importance to our constituents.
Can anyone with spinal cord injury participate at the Miami Project? return to top
In order to draw reliable conclusions about the effect of a particular therapy, researchers must select volunteers who are similar in their level of injury, functional ability, time past injury and/or their age. We are very grateful to have many research volunteers, in fact, more than our research programs can accept. While we work with a limited number of research volunteers at any one time, the information gained from the studies we conduct improves medical and rehabilitative treatments that benefit all people with spinal cord injury. (See Spring 1997 Science Update and Answering the Call: Subjects Step Forward)
How can I participate in research at the Miami Project? Can I be put on a waiting list? return to top
Invitation to participate in a research program at the Miami Project depends on an individual fitting the criteria set by the researchers for a specific study. Furthermore, a volunteer must want and be able to commit the time and resources needed to come to Miami to participate in and complete the study. The Miami Project does not have a waiting list per se, because each study has different criteria. We do maintain a computerized database of interested SCI volunteers, through registration of Intake Forms that detail a person's injury characteristics. People are identified as eligible for ongoing studies in a number of ways: through a telephone inquiry, a visit to the Miami Project, or a computer search of our database. If an individual wishes to be considered for future studies, they should complete an Intake Form. When researchers are looking for new volunteers, this database is searched to identify and contact individuals who may be eligible for that specific study.
Do you collaborate with other centers? Who's ahead? return to top
Yes, collaboration is very important both to allow Miami Project scientists to stay at the cutting edge and to accelerate overall progress in the field of SCI research. Though scientists at different centers are exploring different strategies, they communicate often through meetings, publications and private discussions. Often these communications lead to sharing of resources and ideas. Thus, no center can or should claim to be alone in their race for a cure for SCI. Miami Project researchers are involved in many collaborations and are in communication with virtually all major SCI research groups. We have described some of our collaborative efforts in past newsletters articles entitled, "Collaborative Effort Accelerates Progress" and "Collaboration to Accelerate Progress from Bench to Bedside." The Miami Project also has strong associations with other SCI advocacy groups and is a founding member of a collaborative effort called the International Campaign for Cures of Spinal Cord Injury Paralysis (ICCP).
|
