EXPERIMENTAL TREATMENTS FOR SPINAL CORD INJURIES
EXPERIMENTAL TREATMENTS: WHAT YOU SHOULD KNOW ABOUT PARTICIPATING IN CLINICAL TRIALS
Increasingly, advances in spinal cord injury (SCI) research are finding their way into clinical practice. Many of these experimental treatments are currently undergoing clinical trials or are preparing to enter the clinical trial phase of their development. However, a number of experimental therapies, such as cellular transplants, are being introduced into clinical practice without a valid clinical trial program being completed, leaving their safety and efficacy untested. This is a great concern to researchers, clinicians, and most importantly people with SCI.
For people with SCI, their families, friends and caregivers, the decision to receive an experimental treatment or enter a clinical trial is a challenging one. To establish a set of guidelines for the design and conduct of valid clinical trials for SCI, an expert panel of researchers and doctors with extensive scientific and clinical experience in SCI was formed in 2004. The panel, supported through the ICCP (International Campaign for Cures for spinal cord injury Paralysis), developed a set of 4 papers outlining the guidelines for the conduct of SCI clinical trials, which were published in the Nature journal, Spinal Cord (see below). In addition to these peer-reviewed publications, the panel summarized these guidelines in an easy-to-read booklet.
As a member of the International Campaign for Cures of spinal cord injury Paralysis (ICCP), The Miami Project to Cure Paralysis supports the published position statement regarding the sale of unproven cellular therapies.
- It is unethical to charge people money for experimental treatments that have not been proven safe and effective by clinical trials conducted in a proper manner.
- Testimonials reported by people who have received a treatment, or by their family members, are not valid medical evidence.
- Proper control groups are needed to evaluate the placebo-effect; the people profiting financially from the treatment should not be measuring safety and efficacy, they are potentially biased by financial gain.
- There are significant risks associated with cell-based treatments. Cells cannot be taken out once they are put inside the body. Therefore, very thorough long-term follow-up should be provided at no cost to the participant.
- People who receive unproven cellular treatments will most likely be excluded from future scientifically valid clinical trials.
“We do not rule out the possibility that cellular therapies may improve function and quality of life for recipients and justify the risks, but insist that the onus is on the providers to deliver such proof from a valid clinical-trial program.” We believe that it is unethical to sell unproven therapies and we do not advice people with spinal cord injuries to participate in such treatment procedures. The complete ICCP statement was published in Spinal Cord (2009) 47: 713-714. An updated version was published in 2015
FOR THOSE WITH SPINAL CORD INJURY, THEIR FAMILIES, FRIENDS AND CAREGIVERS
FOR SCIENTIFIC AND CLINICAL COLLEAGUES
Guidelines for: The Conduct of Clinical Trials for Spinal Cord Injury (As developed by: The International Campaign for the Cure of Spinal Cord Paralysis panel)