An Emory research team completed the initial phase of a clinical trial series to implant stem cells into the spinal cords of adults suffering from Lou Gehrig’s disease — the first attempt to do so in the U.S. — on Wednesday.
Assistant Professor of Neurosurgery Nicholas Boulis, who developed the particular stem cell implantation technique used, led the team in the initial surgical implantation of the stem cells.
Nurse Coordinator Meraida Polak said in a previous interview with the Wheel that researchers hope the stem cells will release growth factors that can support a healthy nervous system and increase chemicals to remove toxins from the nervous system.
The disease, also known as amyotrophic lateral sclerosis (ALS), causes the nervous system to degenerate, leaving patients with an average life expectancy of two to five years after diagnosis.
Boulis said that he hopes to see post-trial improvements.
“It’s not designed to cure ALS, though we hope to see positive effects,” Boulis said in a previous interview with the
Wheel.
The patient is now in the postoperative period, Boulis wrote in an e-mail to the
Wheel.
He expressed concern over the patient’s ability to tolerate the immunosuppressive drugs, which inhibit activity of the immune system. He added that they will soon begin to screen individuals for entry into the next slot for the clinical trials.
“In ALS, we believe that the main problem people have is the loss of motor cells, so we started designing a clinical trial, and discussions with the FDA led to a series of experiments to test and prove how we could conduct surgery on humans,” Boulis said in a previous interview with the
Wheel.
Depending on the success of this initial trial, there will be a follow-up phase II trial or a modified phase I trial that utilizes the techniques of surgical implementation.
“We are really focused on demonstrating safety,” Boulis wrote. “This patient’s disease is so advanced that it may not be possible to see the effects of these cells.”
Brad Nordheimer, an investor in NeuralStem Inc., the company financially supporting the stem cell research efforts, expressed a vested personal interest in the clinical trials following his cousin’s death three years ago due to ALS.
“I hate to see anybody go through what she went through,” Nordheimer said.
He added that he invested in the company because of their different approach in trying to help ALS patients with groundbreaking techniques, such as the stem cell trials.
According to Boulis, the protocol under review by Emory’s Human Investigations Committee received approval from the Institutional Review Board for the first 12 patients permitted by the Food and Drug Administration (FDA).
— Contact Roshani Chokshi.