"In the phase 2 study, we will begin to learn the characteristics of individuals who respond to the therapy in terms of their age, severity of injury and time since injury," says Anthony J. Stem cells can potentially provide trophic support to the injured spinal cord microenvironment by modulating the inflammatory response, increasing vascularization and suppressing cystic change. After the primary injury, microenvironmental changes inhibit axonal regeneration. Spinal cord injury has a complex pathophysiology. "Our patient also reported a strong improvement with his grip and pinch strength, as well as range of motion for shoulder flexion and abduction," Dr. Clinical signs of efficacy in both motor and sensory function were observed at three, six, 12 and 18 months following the stem cell injection. Stem cells were injected nearly a year after his injury and several months after his improvement had plateaued. But that progress plateaued six months after the injury. As described in the February 2020 issue of Mayo Clinic Proceedings, the neurological examination at the time of the injury revealed complete loss of motor and sensory function below the level of injury.Īfter undergoing urgent posterior cervical decompression and fusion, as well as physical and occupational therapy, the patient demonstrated improvement in motor and sensory function. The initial participant in CELLTOP phase 1 sustained a C3-4 ASIA grade A spinal cord injury. The spinal cord injuries must be American Spinal Injury Association (ASIA) grade A or B. Study participants must be age 18 or older and have experienced traumatic spinal cord injury within the past year. Patients randomized to the medical management arm will eventually cross over to the stem cell arm. In CELLTOP phase 2, 40 patients will be randomized to receive stem cell treatment or best medical management. "One objective in our future studies is to delineate the optimal treatment protocols and understand why patients respond differently." Among the 10 participants in our phase 1 study, we had some nonresponders and moderate responders," Dr. "Not every patient who receives stem cell treatment is going to be a superresponder. The first participant in the phase 1 trial was a superresponder who, after stem cell therapy, saw significant improvements in the function of his upper and lower extremities. Bydon examining patient #1 in the CELLTOP phase 1 trial
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