Neuralstem wants trials on spinal patients 

Posted: 7:59 pm Wed, August 25, 2010
By Ben Mook
Daily Record Business Writer

Biotech company Neuralstem Inc. said Wednesday it wants to test its stem cell treatment on patients with spinal cord injuries that have caused paralysis.

The Rockville-based company filed an application with the U.S. Food and Drug Administration seeking approval to start a new clinical trial, hopefully by the end of the year. The spinal cord injury research would follow a current project that is testing the effectiveness of spinal cord stem cells on patients with amyotrophic lateral sclerosis, or Lou Gehrig’s disease.

“Since this is similar to the ALS trials, once we felt comfortable with the safety we felt it was time to move forward,” Neuralstem CEO and President Richard Garr said.

In the proposed trial, researchers would inject spinal cord stem cells into 16 volunteers suffering from complete paralysis who had been injured up to two years beforehand.

Eight of the patients would have mid-back injuries with no motor or sensory function below the injury, while the second group would include patients with spinal injuries in the cervical area and no motor or sensory function below the injury.

With the ALS trial, the company directly injected stem cells into the “gray matter” of the spinal column using specially designed medical devices. In the proposed trial, the company would use a similar technique, but injections would be made at the site of the original injury.

Researchers hope the injections of healthy and functional spinal stem cells will replace or repair damaged and missing nerve cells at the injured areas.

Neuralstem’s spinal stem cell line is fetal-derived, coming from donated, eight-week-old tissue. Garr said that unlike embryonic stem cells that can be programmed to become other kinds of cells, Neuralstem’s fetal-derived cells are already “committed” to being central nervous cells.

The trial would not be affected by Monday’s judicial decision that halted federal funding of stem cell trials using embryonic stem cells. Neuralstem, a publicly traded company, would not use National Institutes of Health funding, and the U.S. District Court ruling did not affect private or state funding for stem cell trials.

Neuralstem said there are more than 10,000 new spinal cord injuries in the U.S. each year. A recent survey by the Christopher & Dana Reeve Foundation found there were approximately 840,000 people living with chronic spinal cord injury. According to the National Spinal Cord Injury Association, 85 percent of spinal cord injury patients who survive the first day are still alive 10 years later.

Shares of Neuralstem gained 12 cents, or 6.67 percent, Wednesday to close at $1.92. Shares had reached as high as $2.12 on the news of the clinical trial.

Neuralstem reported this month that it recorded a net loss of $4.9 million, or 12 cents a share, in the second quarter, compared to a net loss of $3.2 million, or 9 cents a share, in the corresponding quarter of 2009. The company attributed the change to the associated costs of moving its treatments from “the laboratory into the clinic.”

Neuralstem plans to conduct other trials on central nervous system diseases including ischemic spastic paraplegia and Huntington’s disease.