Operation marks another step forward in stem cell research

Atlanta (CNN) -- A 50-year-old man from Trion, Georgia, is the first person to be injected with stem cells in the upper part of the spinal cord, making him yet another pioneer in the scientific quest to use stem cells to heal.
Richard Grosjean received the treatment Friday. He is part of an ongoing FDA-approved clinical trial that is testing the safety of injecting stem cells into the spinal cords of patients with amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig's disease.
Grosjean's ALS was diagnosed a little over two years ago, his wife, Tracie, told CNN. He can still walk with a cane, but he has a lot of weakness on his left side and has trouble with his speech.....
.....The cause of ALS is unknown, but the disease is fatal because nerve cells, or neurons, in the brain and spinal cord needed to tell muscles to move, waste away or die. Early in the disease, patients have difficulty speaking and walking, both symptoms Grosjean now has. Eventually, the disease cuts off communication between the brain and chest muscles, so patients can no longer breathe.
Most people die from respiratory failure, according the National Institutes of Health, and most patients die within three to five years of diagnosis.
The team of researchers in this clinical trial is headed by University of Michigan neurologist Dr. Eva Feldman, who designed the trial; neurologist Glass, who is in charge of the clinical trial at Emory University in Atlanta, where patients are getting the injections; and Emory neurosurgeon Boulis, who invented the structure used to safely inject the stem cells into the patient.
In an operation than lasted about four hours, Grosjean received five injections into the cervical, or neck, area of his spinal cord, each delivering 100,000 cells. The cells came from Maryland-based biotech company Neuralstem, which is funding this clinical trial and devised a procedure to grow millions and millions of motor neuron cells from the donated spinal cord tissue of an 8-week-old aborted fetus.......
....Ultimately, the hope is that by injecting the cells into the neck, above the lungs, where the mostly deadly damage is done by ALS, these neural stem cells will reconnect communication from the brain to the muscles, keeping patients alive longer and maybe, one day, curing them.
But that is not the point of the trial at this time. At this point the goal is still to establish that injecting stem cells is safe for the patient, won't cause more damage to the patient, and won't lead to the patient reject the cells. Early data from the first 12 patients, who had injections in the lower back, shows this procedure is safe.
Injecting anything into the spinal cord is very dangerous because it can cause serious damage. To avoid injuring the spinal cord, which is always moving as the patient breathes, the needle delivering the stem cells has to move along with the body.
Boulis invented an apparatus that resembles a miniature oil rig mounted on to the patient's spine. It moves with every breath and holds a super-fine needle through which to inject the stem cells. To prepare for these surgeries, Boulis and his fellow surgeons practiced mounting the apparatus on pigs, which are close in size to humans.......
....... Boulis and his colleagues have come a long way, through trial design; to testing the cells in mice to ensure they don't cause tumors, which sometimes happens with stem cells; to inventing the needle-holding oil-rig-like apparatus; to practicing on many pigs; to perfecting how attach the device to patients.
"Finally we're beginning to inject cells into the segments that control the diaphragm, and to the extent that we are able to do that safely ... this is where we keep people breathing," Boulis said.
And that's ultimately what this clinical trial is about.
Glass described Friday's surgery as being at the beginning of crossing an important threshold. "I think it's a huge step forward. I don't want anyone to think that we have a cure for this disease. We don't. But we now have a whole other way to approach it, and that's really what's exciting and important."
Feldman described the day as the most momentous in their pursuit of using stem cells in the treatment of ALS.......Alan Trounson, president of the California Institute for Regenerative Medicine in San Francisco, agrees, calling the progress in this clinical trial a "big step forward."
Every clinical trial that can show a stem cell procedure to be safe is important, he said.
.........Grosjean, Glass and Boulis are quick to point out that they have to replicate this surgery in other patients. Two more patients will receive the same cell dosages in the near future in this part of the clinical trial.
After telling Tracie Grosjean how well the surgery went, Glass was excited and cautiously optimistic.......
Three days after the surgery, Boulis said the patient was doing well. Neurologically he is where he was before the surgery. His legs and arms are moving, confirming what was monitored throughout the entire surgery. The spinal cord was not damaged....

Read more: CNN  http://edition.cnn.com/2011/11/21/health/stem-cells-als/?hpt=he_c2