TCA Cellular Therapy, LLC has enrolled its first patient to participate in the U.S. Food and Drug Administration (FDA) first adult stem cell clinical trial to treat spinal cord injuries. Enrollee and Marine Veteran, Matt Cole was paralyzed from the chest down in a 2005 insurgent attack in Iraq.
“In theory we expect the cells to repair damaged neurons”
According to the National Spinal Cord Injury Statistical Center (February 2010), it is estimated that up to 311,000 people in the U.S. are living with a Spinal Cord Injury with the average health care and living expenses cost for the first year following the injury as much as $830,000 per patient.
TCA Cellular's neurological team is led by stem cell experts Jose J. Minguell, PhD, Carolina Allers, PhD, and Gabriel Lasala, MD, neurosurgeon Gustavo Gutnisky, MD, and neurologist Srinivas Ganji, MD. The team is scheduled to treat ten patients in Phase I.
"Many spinal cord injury patients have no effective treatment available at this time," stated Dr. Gutnisky. "I'm very encouraged by the results of the pre-clinical trials and anticipate this may become a significant therapy for these patients in the near future."
Utilizing TCA Cellular's proprietary therapy, a couple of thousand adult stem cells have been extracted from the patient's own bone marrow, Mesenchymal Stem Cells have been separated, purified, multiplied to millions and will be infused into Cole's spinal cord later this month.
"In theory we expect the cells to repair damaged neurons," explained TCA Cellular president, Dr. Lasala. "At minimum, our team expects this therapy will provide some improvement to the patient's motory and sensory functions with no side effects."