Correction appended: An earlier version of this article incorrectly referred to the study as the first clinical trial of a stem cell-derived treatment in a reference toward the bottom of the article without clarifying that it was the first of its kind for ALS, not the first of its kind generally.

In a major victory for proponents of stem cell research, the U.S. Food and Drug Administration approved the first-ever human clinical trial of a stem cell treatment for Lou Gehrig’s Disease last Friday. The study will be led by a University of Michigan expert in the field.

Dr. Eva Feldman, the director of both the U-M Amyotrophic Lateral Sclerosis (ALS) Clinic and the Program for Neurology Research and Discovery, helped develop the treatment and will act as principal investigator for the landmark trial.

Feldman worked with a team of neurologists to develop the new protocol for injecting stem cells into the spinal chord of patients. This system, researchers hope, will reconnect severed lines of communication between the cells of paralyzed ALS patients and delay or reverse some of the disease’s effects.

In an interview yesterday, Feldman discussed the study and what lies ahead for her team of researchers.

ALS, commonly known as Lou Gehrig’s disease, is a progressive neural degenerative disorder that affects roughly 30,000 Americans, according to the ALS Association. About 5,600 people in this country are diagnosed with the disease every year — or 15 new cases every day.

The disease affects nerve cells in the brain leading to the degeneration of motor neurons in the spinal chord. The patient eventually loses control of all voluntary muscle movement. Cognitive functions are usually left undamaged. Notable figures suffering from ALS include renowned physicist Stephen Hawking and musician Jason Becker.

“Currently ALS is a fatal neurodegenerative disease,” said Feldman. “The only available treatment is medication given by mouth.”

Though these medications slow the progression of the disease, Feldman said, they may only increase survival by around three to five months.

The clinical treatment injects stem cells directly into the spinal cord, protecting at-risk motor neurons and potentially rebuilding severed connections.

“We very much want to find a way to stop the progression of ALS,” Feldman said, “rather than just slow it down.”

The Investigational New Drug application was submitted to the FDA by Neuralstem Inc., a Maryland-based biotherapeutics company that is sponsoring the trial and providing all of the neural stem cells used in the treatments.

“They were doing a project where they were using this stem cell to treat spinal cord injuries,” Feldman said. “The really significant results clearly became obvious to me that we should strongly consider doing similar work.”

The first phase of the clinical trials will assess the safety of the treatment. Feldman and her team will conduct the trials at Emory University in Atlanta, Ga., pending the approval of Emory’s Internal Review Board.

Twelve ALS patients at various stages of the disease will participate in this phase of the initial trial, which will allow for five to 10 stem cell injections. Patients will be examined at regular intervals, and a final report will be released after approximately 24 months.

The FDA’s approval of this trial follows the downfall of some key obstacles to stem cell research in the past year.

Proposal 2 was met with controversy by the citizens of Michigan, passing narrowly with 51 percent of the vote. The passing of the referendum allowed for an amendment to the state’s Constitution drawing back restrictions on stem cell research.

Last March, President Obama reversed an executive order by President Bush that restricted the federal funding of stem cell research.

As the first clinical trial of a stem cell-derived treatment for ALS, Dr. Feldman’s work could hold far-reaching effects for the research and treatments of other neurodegenerative disorders, like Alzheimer’s disease and multiple sclerosis.

“The potential role of this trial to increase our understanding of other neurodegenerative diseases is actually quite high,” Feldman said. “However, we won’t really know until we see how stem cells affect the brain.”

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