Emory plans to conduct the first U.S. clinical trial to implant stem cells into the spinal cords of adults with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, beginning in January.

The tentative start date for the trials is Jan. 20, according to Nicholas Boulis, assistant professor of the department of neurosurgery, who developed a stem cell implantation technique.

Neuralstem, Inc., a company that focuses on research involving stem cells derived from human fetal spinal cords, will work with Emory ALS researchers to conduct the trials, according to Emory’s ALS Center website.

Emory was chosen to conduct the trials due to Boulis’ development of a stem cell implantation technique, Nurse Coordinator Meraida Polak said.

“I think that for us to come out of this demonstrating that our techniques are safe and that the [stem cells] are safe is what our trial is designed to do.

It’s not designed to cure ALS, though we hope to see positive effects,” said Boulis.

Ideally, the stem cells will release growth factors that will support a healthy nervous system and increase the amount of chemicals that remove toxic materials from the nervous system, said Polak, nurse coordinator of the project.

The clinical trials will consist of surgical implantation of stem cells into the spinal cord of those with Lou Gehrig’s disease, a degenerative condition of the nervous system with an average life expectancy of two to five years following diagnosis.

Boulis, whose initial work involved pilot studies of stem-cell implantation using devices he had developed at the Cleveland Clinic, said that prior to the actual surgery there was much work involved with fine tuning details of the experiments’ phases.

Boulis collaborated with Clive Svendsen, stem cell and neurobiology expert at the University of Wisconsin, to discuss trials involving stem cell research.

Svendsen had published a paper on neural progenitors derived from human fetal cortexes, and engineered them to secrete a growth factor to enhance their therapeutic capacity, Boulis said.

“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 leading to a series of experiments to test and prove how we could conduct surgery on humans,” Boulis said.

Complications of stem cell implantation include possible tumor growth, Polak said.

According to the Emory’s ALS Center website, researchers plan to begin implantation by enrolling one patient at a time to reach a possible total of 12 patients.

Professor of Neurology and Pathology and Director of the Emory ALS Center Jonathan Glass identified candidates for surgery. The researchers are not allowed to disclose how the candidates were chosen, Polak said.

According to the Emory ALS Center, protocol is under review by Emory’s Human Investigations Committee and is awaiting approval from the Institutional Review Board.

— Contact Roshani Chokshi.