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FREQUENTLY ASKED QUESTIONS

 

When will there be a cure?

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 lead to a cure. The steps for moving a discovery from an idea in the laboratory to a treatment that can be tested in human trials are many. Researchers must gather sufficient proof of functional recovery in animal studies to justify the use of a treatment in human trials. They also need to demonstrate that the results can be repeated in independent laboratories and that the treatment works when tested in larger and chronically injured animals. In addition, to test a treatment in clinical trial, the proposed trial needs to be approved by regulatory agencies such as the Food and Drug Administration (FDA). The total process is incredibly time consuming and expensive, but it is essential to develop reliable cure therapies that can be used in the greatest number of people with predictable beneficial results.

 

 

Why haven’t you tested cell transplantations in a human yet?
First and foremost, patient safety is a real concern.  Experimental cell grafting done before effectiveness and safety have been proven in pre-clinical testing could result in undesirable side effects such as chronic pain, further paralysis or even death. Experimental surgeries may lead to scarring and/or tethering of the spinal cord, which can produce further loss of function. In addition to these risks, 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 carefully considered so an experimental treatment is not taken to clinical trial prematurely, that is, prior to proving its potential benefit and understanding its potential risks via studies with animals.

 

Why is it taking so long to find a cure?
We understand that from the patient’s perspective scientific progress is painstakingly slow. What many people forget is that, up until the 1980s, spinal cord regeneration was believed by most researchers to be impossible. What many also forget is the spinal cord is incredibly complex and scientists are still making new discoveries about how the spinal cord functions. Encouragingly, since the early 1980s, the scope of SCI research has literally exploded as SCI researchers and their colleagues in related fields have achieved important scientific breakthroughs. These breakthroughs include a better understanding of spinal cord injuries themselves, drugs that can limit the amount ofdamage 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 variety of potential treatments in different types of injuries in animals. It is also important to note that one step in testing new therapies is to conduct experiments with chronic injuries. These experiments require months of post-injury and post-grafting time in which to evaluate recovery. Until these treatment techniques are proven to work reliably, however, it would be premature and unsafe to test them clinically (see above).

 

Other countries are offering experimental treatments to people with SCI. Why are they farther ahead?
One may get the impression that other countries are ahead when clinicians offer experimental treatments without testing them in valid clinical trials or before the treatments have been carefully evaluated in pre-clinical testing. Preclinical testing is important to provide sufficient evidence of the treatment’s potential benefit and safety. Once this evidence is obtained, a valid clinical trial is necessary to determine whether any benefits to humans are associated with the treatment or whether they are a result of other factors. If a treatment is ever to be proven effective, preclinical testing and valid clinical trials will be essential.  When a group offering an experimental treatment does not follow international guidelines for clinical trials in SCI, this may give the false impression that they are ahead. One may also get this false impression when, based on the testimonies of people who have received experimental procedures, the clinicians claim the procedure is beneficial and safe. In clinical trials, anecdotal evidence (testimonials and case studies) is insufficient to prove benefit. Claims of benefit should be made only when data collected from participants in careful follow-up assessments in valid clinical trials show the benefit to be the result of the treatment.

 

Do you collaborate with other centers?
Yes, collaboration is very important 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 regularly 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 quest for a cure for SCI. Miami Project researchers are involved in many collaborations and are in communication with virtually all major SCI research groups. 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).

 
 
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