Posted on

* Don Wright Interview by Dr. Sanjay Gupta

KOSIK: And every week, Dr. Sanjay Gupta brings us incredible stories of recovery and survival from around the world. In today’s “Human Factor,” our chief medical correspondent reports on a 71-year-old who’s continued his dream of running marathons while fighting a dangerous form of cancer, one where patients are rarely cured.

http://www.cnn.com/video/#/video/health/2013/01/09/human-factor-don-wright.cnn

SANJAY GUPTA, CNN CHIEF MEDICAL CORRESPONDENT: Don Wright’s career spanned engineering, being a company vice president, and the law. At age 62, he discovered a new passion — marathons. Nine year ago, days after running his first 26-mile race, he got some devastating news.

DON WRIGHT, MARATHON RUNNER/CANCER PATIENT: I had gone to the doctor a couple of times for pain in my back. It was multiple myeloma.

GUPTA: This is a cancer of the blood where the white blood cells invade the bone marrow causing pain, usually in the back or the ribs. Patients are rarely cured. But Wright refused to let that slow him down, even qualifying for the Boston marathon.

WRIGHT: We got this devastating diagnosis, and we just — my family and I, we just kept on going. You know, there wasn’t any reason to stop and be sorry, you know. We kept running marathons.

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WRIGHT: It feels wonderful, I’ll tell you. A philosophy of life that I have is live one day at a time and make it a masterpiece, and that was a masterpiece.

GUPTA: Wright wasn’t sure he could fulfill his dream because the median survival for his cancer is just five years. Prognosis does vary depending on age and stage of the disease. He’s had a number of treatments that have failed. But for the last four-and-a-half years, Wright’s taken an experimental drug, one pill at night, that’s worked. It’s kept the cancer at bay.

WRIGHT: It doesn’t cure the cancer, but it keeps it stable so it’s not hurting me. And I can still run. And I can still enjoy life, and I’m riding that for all it’s worth.

GUPTA: His advice to others facing what seemed like insurmountable odds, take charge of your own destiny and never give up hope.

Dr. Sanjay Gupta, CNN, reporting.

Posted on

* Human Factor: Running marathons while fighting cancer at 70

Click on the link below to view the video
http://www.cnn.com/video/#/video/health/2011/11/29/hf-don-wright-marathon.cnn
November 29, 2011

Human Factor: Running marathons while fighting cancer at 70

In the Human Factor, we profile survivors who have overcome the odds. Confronting a life obstacle – injury, illness or other hardship –- they tapped their inner strength and found resilience they didn’t know they possessed. This week we meet Don Wright, who developed a passion for running marathons later in life, right before getting diagnosed with cancer. His goal is to run 50 marathons in 50 states.

“I’ve made an appointment with an oncologist for you.” These are words that no one wants to hear from their doctor, ever. It was multiple myeloma, an incurable blood cancer with a median survival of about five years after diagnosis.

I had lost weight at Weight Watchers’, then started running, and had just run my first marathon. Myeloma attacks the bones, and a broken bone would stop my running, so I was determined to run the Boston Marathon before I lost the ability to do so. I qualified for Boston and then ran it, then a few more marathons here and there. I had no reasonable expectation of finishing all 50 states.

That was eight years ago. I’m now 70 years old and since the diagnosis I have run 60 marathons in 41 different states, including the Seattle Marathon last Sunday. After some treatments that didn’t stop it, the cancer has been stable for three and a half years on a novel investigational drug called pomalidomide, just a pill that I take once a day. I’m a beneficiary of modern innovation and research.

I have this incurable cancer, and my most pressing health problem is runners’ knee!
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My doctors are uniformly enthusiastic about the running as a way to strengthen my immune system and my bones. “We’re not sure why it works, but keep doing what you’re doing.”

We can’t know how long this treatment will continue to keep the cancer from growing, but for now, my family and I are relishing the extra time that I have been given, by traveling and doing these marathons together. They are a celebration of life!

I stand at the starting line and get choked up, thinking of the people I know who haven’t survived myeloma, and how lucky I am to be alive and able to run a marathon. I can’t wait to start the race. Even on a cold, rainy day in Seattle, I enjoyed every moment. As I run, I sometimes imagine that I’m just floating along, drifting past the scenery. I feel wonderful, and we’re going for all 50 states.

Since August I have also been running on behalf of Team Continuum, a charity started by a man with myeloma. It helps patients and their families meet their daily expenses while fighting cancer. Here’s how you can help:

– Click “like” on this Facebook page and a donor will contribute $5.00 at no cost to you: facebook.com/ERACECANCER.

– Go here if you would like to make your own donation directly to
TeamContinuum.net.

With my cancer I am very lucky to be able to run marathons, and I feel even more privileged to run them on behalf of other cancer patients.

Posted on

* Cancer patient runs marathons

Cancer patient runs marathons

Sanjay Gupta MD|Added on November 28, 2011

Dr. Sanjay Gupta talks to a cancer patient whose goal is to run a marathon in every state.
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http://www.cnn.com/video/#/video/health/2011/11/29/hf-don-wright-marathon.cnn

Posted on

Operation marks another step forward in stem cell research

Operation marks another step forward in stem cell research

http://www.cnn.com/2011/11/21/health/stem-cells-als/index.html?iref=allsearch

By Miriam Falco, CNN

updated 3:00 PM EST, Mon November 21, 2011

STORY HIGHLIGHTS

  • For the first time, stem cells are injected into the spinal cord in the neck
  • It is part of a trial to see if the procedure can be safely done
  • “I feel like we finally arrived,” says the surgeon who invented a key structure

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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 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.

“I’m pretty much his voice for him,” Tracie Grosjean said.

Through his wife, Grosjean says “he has 100% confidence in Emory and Dr. (Jonathan) Glass and Dr. (Nicholas) Boulis and the good Lord that good things will come” from the trial.

While the Grosjeans know this procedure is likely to be more helpful to others in the future who have to deal with this “horrible disease,” they have hope and faith that some good will come of this for them, too. In addition to praising Emory University, Tracie also praises her husband’s employer, Mount Vernon Mills, which she says has “bent over backwards” to keep him employed throughout his illness giving him a sense of purpose.

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.

These are not embryonic stem cells, like the ones used by California-based company Geron, which has injected cells grown from human embryonic stem cells into the spines of at least four patients with complete spinal cord injuries.

Embryonic stem cells have the ability to become any type of cell in the body. One week ago, Geron decided to stop their trial because it was too expensive to continue.

The cells in this ALS trial were taken from the spinal cord of the fetus, so they have already gone down the path of becoming nerve cells. Researchers are hoping to show that injecting neural stem cells — the precursors to nerve cells — into the spinal cord of ALS patients is safe.

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.

The first 12 patients in this clinical trial had the “rig” mounted on their lower back, giving surgeons a flatter surface to work with.

But the injection site on Grosjean is on the neck, posing a new challenge for Boulis.

“It didn’t fit exactly as I had envisioned it,” he said immediately after the surgery. “In fact, I ended up applying it much in the same way that I had applied it in pigs, as opposed to how I had envisioned it in humans, and that gave us nice solid fixation.”

Boulis screwed the structure to the spine on one side, but to the skull on the other side.

With the spinal cord exposed after removing part the spine and peeling back layers of muscle and membranes protecting the cord, the injections slowly began. They have to be slow — injecting the cells too fast alone can damage the cord or the cells can spill out, never having a chance to nestle into the spinal cord.

After the third injection went smoothly, Boulis paused to note what they were accomplishing at this moment. After the surgery he said, “it is a big milestone for us. … I think the biggest thing about this is that I feel like we finally arrived.”

That’s because 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.

“I have spent over 25 years taking care of patients with ALS, and I feel today I can go back to them and give them hope,” she said.

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.

“These are tough diseases,” Trounson said. He agreed that being able to safely inject stem cells into the cervical area of the spinal cord is an important step forward for patients with ALS and potentially other neurodegenerative diseases such as multiple sclerosis.

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.

“We’re moving forward,” he said. “We don’t have a treatment yet, we don’t have cure yet and there’s no evidence yet even putting these stem cells on the spinal cord is going to either slow the disease or prevent progression or even make it better.”

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.

Tracie Grosjean said her husband is still in pain, which doctors say is expected given the surgery. But she said the doctors tell them he’s doing great and they hope be home in time for Thanksgiving.

© 2011 Cable News Network. Turner Broadcasting System, Inc. All Rights Reserved.

Posted on

Patient, doctors encouraged by ALS trial

By Miriam Falco, CNN

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http://www.cnn.com/2011/09/28/health/early-als-trial-results-encouraging/index.html?hpt=he_c2

(CNN) — A little more than two years ago, Ted Harada felt his left leg weakening, and he found himself quickly running out of breath. Doctors first thought he had asthma, but in May 2010 they told him he probably had ALS, or Lou Gehrig’s disease.

In August 2010, doctors confirmed Harada, then 38, had the fatal disease, and he knew it was progressing.

“Every month they [doctors] could see deterioration,” Harada said.

ALS patients lose muscle function in the lungs until they can no longer breathe. Most people with ALS die from respiratory failure within three to five years of first symptoms, according to the National Institute of Health. The disease causes nerves to wither and the lungs to stop working. About 10% of ALS patients live 10 years or longer.

Harada joined a clinical trial at Emory University in Atlanta, where doctors were injecting neural stem cells — the precursors to nerve cells — into the lower spinal cord of ALS patients.

Before the procedure, Harada walked with a cane and would get winded just by walking to the mailbox. He had to quit his job as a manager for a shredding company. He was so tired he couldn’t play with his three children. He was too weak to pick up his youngest child. He couldn’t even open a Ziploc bag.

Harada hoped the treatment would help, but he didn’t expect it to. However, two weeks after getting the stem cell injections in March, he says he started to feel better.

“It’s been nothing short of miraculous,” he says. “I cannot begin to explain the difference it has made.”

He hasn’t touched his cane in months, he says, and his breathing has improved.

“I was afraid I would wake up and the improvements would be gone,” Harada said.

Dr. Jonathan Glass, who is overseeing the clinical trial at Emory, and Dr. Nicholas Boulis, who invented the surgical procedure used to inject the stem cells, explained to patients that participation in the trial would not cure or even benefit them personally, but it would help doctors learn more about how to treat ALS in the future.

The first phase of any clinical trial is to prove that a treatment won’t injure patients, not that the treatment works, said Dr. Eva Feldman, who designed the clinical trial at Emory.

The first part of the ALS study, sponsored by the Maryland-based biotech company Neuralstem, is designed to show that the surgical procedure to inject the stem cells into the spine is safe, and that the patients’ bodies won’t reject them. According to researchers, the cells did not harm any of the 12 patients in the Emory study, nor did they accelerate the progression of their ALS.

“I need to temper my excitement because it’s a very small patient population,” said Feldman, president of the American Neurological Association. But the facts are not discouraging. She presented early data from the study Monday at the neurological group’s annual meeting in San Diego.

“We have cautious optimism that a few of the patients may have slowed in their progression of lower extremity weakness, and one patient may have improved,” her report said.

Of the 12 patients in the trial, two have died.

John Cornick’s disease had progressed further than Harada’s by the time he received the stem cell injections in 2010. He was already in a wheelchair, and he knew participating in the clinical trial wouldn’t cure him. But he told CNN in April 2010 that the only way doctors were going to figure out how to cure ALS was to have people willing to participate in clinical trials.

“For me it just seemed like the right thing to do,” he said.

Cornick died of ALS in May. Another patient in the study, a 39-year old man, died of a heart attack.

Feldman said the conditions of eight of the remaining 10 patients have not changed. Based on these results, she and her team in Georgia are asking the Food and Drug Administration to allow them to move to the next part of the trial: Injecting stem cells higher on the spine – into the cervical spinal cord, which is in the neck.

Harada is optimistic that research like this will give other patients hope and lead to treatments in the future. He realizes he hasn’t been cured, but it’s like his clock has been set back, he says. He feels like he did when symptoms first started to appear in 2009.

“I know I still have ALS. I am so grateful for this gift regardless of how long or short it lasts,” he said.

“I can go through most days without thinking I have ALS.”

Posted on

Stem cell treatment goes from lab to operating room

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By Miriam Falco, CNN Medical News Managing Editor
May 4, 2010 8:10 a.m. EDT

http://www.cnn.com/2010/HEALTH/05/04/stem.cells.lou.gehrigs/index.html

Atlanta, Georgia — Imagine having your back cut open, part of your spine removed, a stabilizing device that resembles a mini oil rig mounted on your back, the outer membrane of your spinal cord sliced open and experimental stem cells injected into it — all for the advancement of science because it’s not expected to benefit you.

John Cornick, 51, did just that earlier this month as part of a groundbreaking clinical trial.

Almost a year ago, Cornick was told he had ALS — better known as Lou Gehrig’s disease. The diagnosis left him “fairly devastated,” he says.

He knew the prospects were grim because there is no cure.

But John wasn’t giving up so quickly, nor was his wife, Gina.

“I knew he was a fighter from the beginning and he really wanted to do something,” Gina Cornick says. She found information about a clinical trial on online and immediately signed him up, even though she had no idea where it was being held.

ALS destroys the nerve cells in the brain and spine which control muscle movement. When the brain can no longer tell muscles to move, they eventually die, depriving the patient of the ability to move arms and legs and eventually breathe.

The goal of this phase 1 trial is to determine whether fetal stem cells can safely be injected into the spinal cord. Ultimately, researchers hope to show that these cells may slow or halt the progression of the fatal disease.

But for now, the only goal is establishing safety.

Clinical trial

The Cornicks live in North Carolina, just a few hours from Atlanta, Georgia’s Emory University, the site of the trial. It is the first FDA-approved clinical trial to inject fetal stem cells directly into the spinal cord of an adult.

Dr. Jonathan Glass, director of Emory’s ALS center, is overseeing the trial. Cornick and two previous patients in the trial are heroes, says Glass, because at this point, the trial will likely produce only information, not results.

“In reality what do these patients have? Time, families and their life and we’re putting all of these at risk,” says Glass.

Dr. Lucie Bruijn, science director of the ALS Association, says the progress being made in this clinical trial is exciting. “We’ve been able to move it forward … from animal testing now into actual patients.” The treatment had not been tried in humans before.

Glass hopes this trial will lead to a new form of treatment for people with ALS. “We’re testing multiple things: We’re testing the safety of the surgery; we’re testing the cells; we’re testing immunosuppressants[because scientists do not know whether the body will reject the cells].” They are also testing how well Cornick handles this major surgical procedure, says Glass.

“After we’re finished with the first 12 or 18 patients we will know whether this is surgery that patients can tolerate.”

As he was prepped for surgery, Cornick was hopeful but realistic. “Well, of course you’d like to get up and walk … but I know that’s not going to happen.”

Stem cells

The stem cells used in the surgery are shipped overnight from Maryland, where Neuralstem, the company funding the trial, is based. The stem cells’ source is donated tissue from the spinal cord of an 8-week old aborted fetus, which was donated to the company. The company has developed a method that enables growth of millions of stem cells from this single source of human nerve stem cells.

Before the surgery can begin, a technician at Emory has to verify that a majority of stem cells made it to Atlanta alive. At least 70 percent have to be viable. In this case three samples under the microscope showed 85 percent of the cells arrived alive.

Lead researcher Dr. Eva Feldman, a neurologist at the University of Michigan, designed the trial just four years ago. After a lot of animal testing, her team determined that using fetal nerve stems rather than human embryonic or adult stem cells (such as bone marrow stem cells) was most effective, she says.

Stem cells have the ability to turn into different cells in the body. However, human embryonic stem cells, which come from 4- or 5-day-old embryos, also been found to sometimes turn into cancer cells. Fetal stem cells, such as those used in this trial, are a few weeks older and have already taken on a specific identity — in this case nerve cells.

Feldman says the fetal stem cells used in this trial did not become any of the unwanted cell types. “That’s very, very important,” she says.

Surgery

Animal testing also proved very useful when it came to figuring out how to actually inject the stem cells. Emory University’s neurosurgeon Dr. Nicholas Boulis invented the device that holds the needle that injects the stem cells. The goal is to inject the cells without injuring the spine and causing even more paralysis. He practiced on 100 pigs before attempting the procedure on a human.

Boulis says it’s critical that the injection be done in a very slow and controlled way.

“If you inject quickly, you’re going to create pressure at the head of the needle and that can cause damage,” Boulis says. That pressure can also inflate an area in the spinal cord which could cause the stem cells to seep back out of the cord when the needle is pulled out, he says. “So by pumping [cells] in slowly you have more security that you are not going to have reflux and you’re not going to have damage.”

Dr. Jeffrey Rothstein, who heads the ALS research center at Johns Hopkins University and is not connected to this trial, said work on this method is a big achievement. “This is purely about how to surgically deliver cellular therapy to spinal cord,” he says. “It’s never been done before.”

After the spinal cord was exposed, the injections began. Cornick got five — each one contains about 100,000 stem cells.

The four-and-a-half hour surgery went smoothly, Boulis, says. “There were no surprises.”

Post-surgery

A day after surgery, Cornick was lying flat in a hospital bed, chatting and laughing with some friends from North Carolina.

One week after surgery, he says he felt amazingly well and was still hopeful the cells would do some good for him.

Two weeks later Cornick’s stitches were removed and he was able to drive home. But he will be making frequent visits back to Atlanta as Glass and his team continue to monitor him.

Neuralstem’s Chief Scientific Officer Karl Johe says after the trial’s safety board reviews all existing data, including Cornick’s results, a fourth patient can be treated with the stem cells.

“Patients Four, Five and Six will receive twice as many [stem cell] injections,” Johe says. They will get five more injections on the other side of the spinal cord compared with Cornicks’s surgery.

Cornick expects the researchers will follow his progress for a long time. He says he understands the need for people to be willing to participate in experimental research like this.

“For me it just seemed like the right thing to do. I almost felt I had an obligation to do this,” he says. “To help other people and myself.”

Posted on

Stem Cell Medical Breakthrough?


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CNN’s Dr. Sanjay Gupta reports on a new stem cell clinical trial that is making history.

Dr Sanjay Gupta
Stream from CNN Here

http://www.cnn.com/video/#/video/health/2010/04/30/gupta.medical.breakthrough.cnn?iref=allsearch

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First U.S. stem cells transplanted into spinal cord

CNN Health

First U.S. stem cells transplanted into spinal cord

By Miriam Falco, CNN Medical News Managing Editor

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January 21, 2010 11:35 a.m. ESTJanuary 21, 2010 11:35 a.m. EST
Stem Cells Picture

Stem cells like these were injected into the spine of an ALS patient.
STORY HIGHLIGHTS
  • Fetal cells injected into spine of man with advanced ALS
  • There is no cure for ALS, better known as Lou Gehrig’s disease
  • At least 12 patients expected to participate in early research on stem cells and ALS
  • These are neural stem cells, which have ability to turn into different types of nerve cells

ATLANTA, Georgia (CNN) — For the first time in the United States, stem cells have been directly injected into the spinal cord of a patient, researchers announced Thursday.

Doctors injected stem cells from 8-week-old fetal tissue into the spine of a man in his early 60s who has advanced ALS, or amyotrophic lateral sclerosis. It was part of a clinical trial designed to determine whether it is safe to inject stem cells into the spinal cord and whether the cells themselves are safe.

ALS is a fatal neurodegenerative disease that causes the deterioration of specific nerve cells in the brain and spinal cord called motor neurons, which control muscle movement. About 30,000 Americans have ALS at any given time, according to the ALS Association.

There is no cure for ALS, which is better known as Lou Gehrig’s disease, named after the New York Yankees’ first baseman and Hall of Famer who retired from baseball in the 1930s after being diagnosed with the disease.

As the illness progresses, patients lose their ability to walk, talk and breathe. Patients usually die within two to five years of diagnosis, according the ALS Association.

Neuralstem Inc., a Rockville, Maryland-based biotech company, received approval from the U.S. Food and Drug Administration to conduct the clinical trial in September. The company is fully funding the research and provides the stem cells that are being injected into the patients.

Neuralstem announced the start of the clinical trial in a news release Thursday.

Longtime ALS researcher and University of Michigan neurologist Dr. Eva Feldman is overseeing the first human clinical trial of a stem cell treatment in ALS patients.

“We are entering a new era of cell therapeutics for ALS, and in my opinion, it is an new era of hope for patients with ALS,” Feldman said.

At least 12 patients are expected to participate in this early research. They are to receive the stem cell transplants at Emory University in Atlanta, Georgia.

“This is the first study to see if the invasive injection into the spinal cord is safe for the patient,” said Lucie Bruijn, science director of the ALS Association.

This first patient in the clinical trial received several injections of stem cells into the lumbar region of the spinal cord, the area that controls leg function, because most ALS patients first lose muscle function in their legs, according to Karl Johe, Neuralstem’s chairman and chief scientific officer.

Bruijn says there have been a few other occasions outside the United States in which fetal stem cells have been injected into a patient, “but not necessarily using a very [rigorous] trial design.” She adds that there were also a couple of small studies in Italy that injected other types of stem cells into a few patients but that this is the first FDA-approved trial in the United States.

“Our biggest hope for stem cells is to significantly slow the progression the disease,” Bruijn said.

The ALS Association is not providing funding for this clinical trial, but it has supported the work of Dr. Nick Boulis, the Emory neurosurgeon who developed the surgical technique used to inject the stem cells.

Johe invented the technology that allows the company to manufacture billions of copies of stem cells that are taken from a single source of spinal cord cells: cells that were extracted from fetal tissue, which was donated to the company.

“The cells are human neural stem cells,” Johe said, acknowledging that the introduction of stem cells is a very invasive procedure.

“What we are attempting is a novel approach by directly injecting them into the middle of the spinal cord, which to our knowledge has never been done before,” Johe said.

Researchers plan to follow this and future patients participating in this trial for a long time to determine the safety of the procedure.

These particular stem cells — which came from the spinal cord of an 8-week-old fetus — are neural stem cells, which have the ability to turn into different types of nerve cells. These are not the same stem cells as the controversial human embryonic stem cells, which destroy the embryo when the stem cells are removed.

Johe says that once the safety of this type of transplant is determined, he and his colleagues hope to see whether this is a possible treatment for ALS.

“This is not a cure. We are not replacing those motor neurons [nerve cells which tell muscles to contract]. These stem cells don’t generate motor neurons. Instead they protect the still-functioning motor neurons,” Johe explained.

Bruijn says that injecting stem cells into the spinal cord — in the region where the motor neurons are located that affect ALS — is a breakthrough. But she cautions that this is only the first step in the first part of this clinical trial. It’s too early to draw any conclusions about the effectiveness of this treatment, especially since the trial has only just begun.

She notes that everyone involved with the study and other ALS patients have to wait and see what the results of the clinical trial will be.

The FDA granted the first approval for injecting human embryonic stem cells into humans to Menlo Park, California-based Geron Corporation in January 2009. Their trials were expected to start last summer but have yet to begin.