In 2010, the FDA authorized the Geron Corporation to begin embryonic stem cell trials for use on patients with spinal cord injuries. The study is centering on acute injuries, despite trials at different centers internationally that have shown positive results in chronic spinal cord injuries. Seven centers around the country will participate in the trial, including the Shepherd Center in Atlanta. Many scientists welcomed this milestone.
Prior to this, the FDA had not approved human trials with embryonic stem cells. The FDA has finally recognized the evidence supporting that stem cells hold promise and are safe enough to test in humans.
Dr. Dennis Lox, a Tampa Bay area physical medicine and rehabilitation specialist who also specializes in regenerative medicine, notes that he tried to get patients enrolled in the Shepherd study, but due to the long duration of the patients’ injuries, he was unsuccessful.
Dr. Lox has utilized stem cells and regenerative medicine techniques such as platelet-rich plasma to help patients with acute and chronic musculoskeletal injuries, using their own (autologous)
Dr. Lox heralds the initiation of U.S. stem cell trials in humans as the beginning of new era in which previously incurable disorders now have potential for cure.
Dr. Lox notes that researchers internationally are moving forward with numerous stem cell trials. For example, Italian researchers have shown that corneal burns, resulting in blindness, have been cured with stem cell therapy. Therefore, it seems only natural that spinal cord injuries also be studied and given a trial. Dr. Lox points out that if the stem cells are autologous (derived from the patient’s own tissues) there is little chance of any harm coming to the patient – a blind patient cannot become more blind, and likewise, if one is paralyzed, the hope of regaining use of their affected limbs is a very potent force in motivation to find cures for previously-thought incurable disorders.
Dr. Dennis Lox references the case of Rusty Leech, who sustained a spinal cord injury in 1998, leaving his lower body paralyzed. Leech traveled from the U.S. to India in early 2008 for embryonic stem cell therapy. Five months after the therapy, Leech was able to stand up without support and was able to ambulate with braces and a walker. He has since returned to India for additional stem cell therapy.
There had been numerous other instances of patient’s reporting improvement after stem cell therapy and it is time that independent larger scale clinical trials be implemented in spinal cord injury patients.
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Dennis M. Lox, M.D. is board certified in Physical Medicine and Rehabilitation. Since 1990, he has used sports medicine techiques and cutting-edge technology to help heal musculoskeletal injuries and relieve pain.