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Stem Cells: Plural Paths to Harnessing Pluripotency

Stem Cells: Plural Paths to Harnessing Pluripotency

By Anette Breindl
Science Editor

Monday, January 9, 2012

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The most obvious way to use stem cells is to differentiate them in a petri dish and transplant the resulting cells into tissues or organs that are damaged or diseased.

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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.

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After Geron, Stem Cells’ New Saviors

Newsweek

http://www.thedailybeast.com/articles/2011/11/18/after-geron-stem-cells-new-saviors.html

After Geron, Stem Cells’ New Saviors

The biotech Geron may have abandoned its famous effort to treat paralyzed patients with stem cells—but two rivals are swooping in to do groundbreaking trials, Sharon Begley reports. So far, their results are even more promising.

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When the biotech company Geron announced this week that it was halting its pioneering stem-cell program—whose centerpiece is a clinical trial in which four paralyzed patients with spinal-cord injuries were injected with cells derived from embryonic stem cells—the chief scientist at a rival firm had one thought: “I guess that leaves us holding the flag,” Robert Lanza of Advanced Cell Technology told me. “There’s a lot of weight on us to deliver now.”

The Geron study was famous for being the first to treat patients with cells taken from human embryos, and its premature end, due to financial concerns, may seem like a disappointing finale. Fortunately, at least two lesser-known firms are swooping in to continue similar groundbreaking research—perhaps with even more promise and practical applications—and with the potential to revolutionize medicine. One is forging ahead with an extraordinary new test today.

The better known of the two, ACT, has the only other Food and Drug Administration–approved clinical trials using embryonic stem cells, as Newsweek recently described: one trial is for patients with Stargardt’s macular dystrophy and one is for age-related macular degeneration. Both diseases cause blindness. (The studies are notable because Catholic nuns are among the patients, even though the Vatican has condemned stem-cell research.)

stem-cells-begley
Ted Harada, stem-cell patient

But there’s also Neuralstem Inc., which is in the midst of a clinical trial for ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease). Today, if all goes as planned, the first ALS patient will receive an injection of stem cells into the upper part of his spine—the first step toward determining whether the experimental therapy can save ALS patients from dying when their motor neurons, which control muscles, become too weak to maintain breathing.

In ALS, motor neurons in the spinal cord and brain deteriorate to the point where, eventually, they can no longer signal muscles to move. As a result, patients become paralyzed and, when motor neurons controlling respiration die, unable to breathe; most die within three to five years of diagnosis, and only one quarter survive at least five years. There’s currently neither a treatment nor a cure for ALS.

Neuralstem, based in Rockville, Md., uses cells slightly older than the days-old embryonic stem cells Geron used, opting for “neural” stem cells. Unlike embryonic stem cells, which can differentiate into the 200-plus kinds of human cells, neural stem cells have already chosen their fate; they can become any of three kinds of cells in the central nervous system (neurons, astrocytes, or oligodendrocytes). Neuralstem obtained all the cells it has needed so far from an eight-week old fetus that was aborted in 2000.

The procedure has been attempted on 12 ALS patients so far, starting in January 2010. They received either five or 10 injections of 500,000 or 1 million neural stem cells, respectively, into the lower (lumbar) region of the spine, in a procedure developed and performed by neurosurgeon Nicholas Boulis of Emory University, under the direction of Emory neurologist Jonathan Glass. The patient lies on his belly, and Boulis makes an incision and removes two layers of bone covering the cable of nerves that is the spinal cord. Then, guided by an MRI that shows where the motor neurons are, Boulis injects the stem cells, which takes about two minutes.

Although the goal of this early trial is to determine whether the procedure is safe—which it seems to be, although two patients have since died of ALS—the scientists have also seen hints that the cells benefit the patients. Ted Harada, 39, was a manager at Shred-It, a mobile shredding service based near Atlanta, when he was diagnosed with ALS in 2010, and by the time he enrolled in the study he was able to walk only with the help of a cane. Climbing stairs was difficult, he recalls, and he was easily fatigued and often out of breath. He was unable to raise his left leg while sitting if someone pressed on it even lightly, and his left arm was also losing strength.

Since receiving 10 stem-cell injections last March, Harada has improved enough to complete Atlanta’s two-and-a-half mile Walk to Defeat ALS on Oct. 22. “I still have ALS, but I’m starting to see signs of hope,” said Harada.

Studies of lab animals suggest how the neural stem cells might be benefiting Harada and other patients. The cells remain where they are injected in the spine, says Karl Johe, chief scientific officer of Neuralstem, right beside a high concentration of the motor neurons that are being killed by ALS. There, although the stem cells cannot resurrect dead motor neurons, they can keep additional ones from dying, explains Johe: they produce protective molecules.

Protecting neurons only keeps ALS from getting worse, however—they don’t reverse it. One reason Harada regained movement and strength might have been that the injected stem cells also cause axons—the long tails on neurons that connect neuron to neuron as well as to muscle—to regrow. “The connection that the motor neuron makes to the muscle is the first thing that goes in ALS,” explained Glass, possibly because the neuron becomes too weak to support the long axon that connects to the muscle. “It might be that if you can rescue the cell body [with neural stem cells], you can rescue that connection,” said Glass.

Animal studies suggested just that, said Eva Feldman, director of the A. Alfred Taubman Medical Research Institute at the University of Michigan and an unpaid adviser to Neuralstem: “You can hypothesize that if the nerve cell is just about to give up the ghost, the stem cells preserve it and the axonal connection is restored, with the result that the patient has a restoration of function.”

Today, for the first time, Boulis is scheduled to inject neural stem cells not into the lower part of his patient’s spinal cord, to restore movement in the legs, but into the upper region, to target motor neurons that control respiration.

Neuralstem believes that neural stem cells could also treat spinal-cord injury—the condition Geron targeted—and Huntington’s disease, in which neurons in the brain are killed much as they are in ALS. The company has requested FDA permission to launch a spinal-cord injury trial.

‘Many of us were surprised Geron selected spinal-cord injury in the first place,’ said Lanza. ‘It didn’t really make a lot of sense, either commercially or biologically.’

ACT, too, “remains committed to embryonic stem2cell research,” said Lanza. “We have no intention of letting [Geron’s decision] interfere with our mission.” The company’s clinical trial, at UCLA, uses what are called retinal pigment epithelial cells, grown from embryonic stem cells, to treat two causes of blindness, Stargardt’s disease and macular degeneration. (Stem cells from a human embryo are grown in the lab, and after they differentiate into the kind of cell needed for the disease being targeted, they’re injected into patients.) “We’re moving full steam ahead,” said Lanza, making final arrangements for other sites to enroll patients. Although results have not been formally reported yet, the first patients—who received stem cell–derived treatment this summer—are doing well enough, Lanza said, that “both want us to treat their other eye.”

In contrast, it would have taken years for Geron to see whether the cells it had derived from embryonic stem cells helped spinal-cord patients regain movement. “Many of us were surprised Geron selected spinal-cord injury in the first place,” said Lanza. “It didn’t really make a lot of sense, either commercially or biologically. So it’s not too surprising they didn’t obtain any biological effect. Although treating spinal-cord injury has a kind of sex appeal, you have to take reality into account, including not only the market but the chances of success.”

 

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Could This Be the End of Embryonic Stem Cell Research?

Could This Be the End of Embryonic Stem Cell Research?

By Kristen Philipkoski

Nov 15, 2011 3:40 PM

A biotech company that after much turmoil and huge expense launched the first human embryonic stem cell clinical trial in the United States is getting out of the stem cell business.

Geron led the charge to push the U.S. government and society at large to allow use of embryonic stem cells. Scientists believed they could treat myriad diseases because of their ability to become any cell in the human body. But the company has accumulated losses of almost $300 million over the past four years and has halted its stem cell efforts. With few scientists pursuing stem cell research of the embryonic variety, many are wondering if commercial embryonic stem cell research will soon take its final breath.

The cells are controversial because human embryos are destroyed to obtain them. But the company persevered amidst years of public outcry and political punditry and in October 2011 launched the first-ever FDA-approved human trial to treat acute spinal cord injuries. Just four of the 10 approved patients have been treated with Geron’s cells, and now it looks like the other six won’t have their chance. A recently-launched Swiss trial run by Geron will also presumably be halted. The company has laid off 34 percent of its staff and will focus now on cancer treatments. Many patients who held out hope for a paralysis cure will be sorely disappointed.

Advanced Cell Technology is one of the only companies (Stem Cells is another) still using embryonic stem cells. It has human clinical trials active in macular dystrophy and macular degeneration.
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But other companies, like Neuralstem, are poised to pick up the slack using a different and less controversial type of stem cell. Neuralstem uses neural rather than embryonic stem cells, and has already seen remarkable success treating ALS (AKA Lou Gehrig’s disease) patients, which I wrote about here. Neural stem cells are not completely free of controversy: they are taken from a voluntarily aborted fetus. But embryos are not destroyed in order to obtain them. And Neuralstem’s technology allows them to proliferate all the cells they need from a single fetus.

“This was not a surprise to me,” Richard Garr, CEO of Neuralstem, said about the Geron news. “I think the writing was on the wall when Tom Okarma was either pushed out or left on his own. It was pretty clear the they were not interested in being a stem cell company at that point.”

Okarma was Gerons’s CEO for 13 years and was the public face of the company’s fight to use embryonic stem cells.

Meanwhile, Neuralstem has already treated 12 ALS patients, and doctors will treat number 13 on Friday. Garr believes his cells are easier to control and target than embryonic stem cells for treating neural diseases.

Next up for Neuralstem is a human trial testing their cells in chronic spinal cord patients. So we might be saying goodbye to Geron, but not to the hope of spinal cord injured folks getting out of their wheelchairs. [San Francisco Business Times]

Image: Shutterstock/Andrea Danti

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Patient, doctors encouraged by ALS trial

By Miriam Falco, CNN

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updated 11:10 AM EST, Wed September 28, 2011

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.”

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U.S. Stem Cell Companies Find Partners and Revenues Beyond the Water’s Edge

http://www.genengnews.com/analysis-and-insight/us-stem-cell-companies-find-partners-and-revenues-beyond-the-water-b-b/77899444/

Analysis & Insight : Aug 16, 2011

U.S. Stem Cell Companies Find Partners and Revenues Beyond the Water’s Edge

Firms find it easier to navigate regulatory requirements in Asia as well as Europe.

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American companies focused on stem cell treatments and technology platforms have met with success in finding partnerships and revenues overseas in the past decade. And it’s not for the reason many people might think, namely the controversy over U.S. federal funding of human embryonic stem cell (hESC) research.

Two other factors better explain why U.S. stem cell companies have been looking beyond their borders to Asia, according to Bernard Siegel, founder and full-time executive director of the nonprofit Genetics Policy Institute (GPI).

One is the attractiveness of Asian countries as markets for stem cell treatments. That reflects both high population concentrations as well as willingness by national governments to invest in stem cell research as well as companies commercializing such treatments and encourage additional research by outside parties. The other is Asia’s lower regulatory hurdles when compared to the U.S.

“It’s easier to move toward the translational process and get clinical trials cranked up in Asia than the United States,” Siegel pointed out. “I think that’s one aspect of it.”

U.S. companies can do that and more in Europe as well, if one company’s experience is any indication. Cytori Therapeutics has won both initial and expanded indication approval in Europe for its Celution® System family of medical devices and instruments, which is not yet available in the U.S. Celution extracts and separates stem and regenerative cells from a patient’s own adipose tissue.

“What we found as we moved through the European market is that that head-start was really important relative to the U.S. or other places,” Cytori president Marc H. Hedrick, M.D., told GEN.

Japan’s Position

The initial European approval allowed Cytori to expand into Japan where, Dr. Hedrick noted, the company obtained its first clinical experience. The company capitalized on the fact that doctors in Japan can, with a prescription, import technologies approved elsewhere.

“And it just so happened we had a relationship with one of the preeminent surgeons in Japan. In fact, our first 20 patients had breast cancer reconstructions performed in Japan at his university hospital,” Dr. Hedrick recalled.

“At the same time, we identified someone to lead the charge in Japan, that we were very fortunate to get, who was a business leader at Baxter in Japan. One thing led to another, and we now have the majority of our revenues from Japan. And it was all tied back to that original regulatory approval in Europe that allowed us to get into that market very quickly,” Dr. Hedrick added.

Japan’s share of Cytori’s sales tumbled during the first quarter to 30% from 72% a year earlier due to the March 11 Tohoku earthquake and resulting tsunami. Japan is where Cytori, which maintains a Tokyo office, found two investors among some of the country’s corporate giants. Last year Astellas agreed to buy $10 million of Cytori stock. And in 2008, Olympus, a medical device company, led a $17 million private placement financing. Two years prior Olympus made an $11 million milestone payment to Cytori for obtaining CE Mark approval for the original Celution system.

“They provided a significant amount of capital to Cytori, and that was another reason why it made sense to focus on the Japanese market,” Dr. Hedrick said.

Other Countries in Asia

Neuralstem is also involved in partnerships with Asian companies, with deals initially focused on research. While Neuralstem last year established a wholly owned subsidiary in China, it has yet to come to terms with commercial or regulatory collaborators.

By year-end the firm plans to start a clinical trial in China focused on transplantation of cells into the brain to treat stroke. The trial would take place at Beijing’s BaYi Brain Hospital, which has been working with Neuralstem to prepare a clinical protocol for treatment of motor deficits due to ischemic stroke.

In Japan the company came to terms with the wholly owned subsidiary of Sumitomo, Summit Pharmaceuticals, to market development and licensing rights for NSI-189, Neuralstem’s lead small molecule neurogenic compound. It is currently in an FDA-approved Phase I trial for major depression. The company has said it intends to take NSI-189 through Phase II trials before seeking a partner for worldwide rights.

Neuralstem has also entered into collaborations in Taiwan, including one with China Medical University & Hospital, to advance development of its human spinal cord neural stem cell therapies for amyotrophic lateral sclerosis. It is also working with the hospital to commence a clinical trial focused on treating stroke.

Additionally, in India, the company is planning a clinical trial for later this year to assess the ability of its cell therapy to treat spinal cord injury. The Indian market is so large that companies like Neuralstem need to find a technological partner first to ensure access to the best neurosurgeons it can find, according to Richard Garr, CEO. “We’re happy to do the proof of principle human studies ourselves before we look for a commercial and regulatory partner.”

Neuralstem notes that it has done most of its proof of principle collaborations with American universities such as the University of California, San Diego and the University of Michigan. “We haven’t gone overseas because we can’t do it here in the U.S.,” Garr remarked. “We went overseas because we believe those are their own independent markets.” Garr points out that commercialization efforts for each country are independent of each other.

“The other reason” to move into Asian countries, he added, “is because if you don’t, someone else will. And then you end up in a fight trying to protect it.”

Neuralstem broke into Asia in 2008, when Korean conglomerate CJ CheilJedang (CJ) bought $2.5 million worth of Neuralstem stock. CJ has an exclusive option to Neuralstem’s spinal cord cell products for five Asian nations: South Korea, Vietnam, Indonesia, Malaysia, and Singapore.

CJ would have the responsibility to take the products through regulatory approvals and commercialization in their markets. Garr expects CJ to decide what its first clinical trial will be and where later this year.

Another U.S. stem cell company that has teamed up with a Korean company is Advanced Cell Technology (ACT). In 2008, ACT joined with CHA Biotech to form a joint venture aimed at developing ACT’s hESC-based hemangioblast (HG) platform for the treatment of blood and cardiovascular diseases.

On July 21, the companies announced that their venture, Stem Cell & Regenerative Medicine International (SCRMI), exclusively licensed the rights to the HG program to ACT for the U.S. and Canada and to CHA Biotech for Korea and Japan.

“The partnership itself had research scientists working on trying to get things ready for starting human trials. And the way the deal works, ACT has hired substantially all the scientists that were working in the joint venture”—10 SCRMI employees in all, Gary Rabin, ACT’s interim chairman and CEO, told GEN.

Rabin said the first IND will be filed for using the HG platform to generate renewable sources of transfusable blood platelets. The platelets could unlock a significant opportunity for ACT, namely in the military wound-care market.

Last year, Robert Lanza, M.D., ACT’s CSO, and Kwang-Soo Kim, Ph.D., of Harvard University’s McLean Hospital and the CHA Stem Cell Institute, won a $1.9 million NIH director’s opportunity award to explore the potential of induced pluripotent stem cells (iPSCs) as a source of universal red blood cells and platelets for transfusion.

Another Asian market ACT is keeping an eye on is China. In March the company reported that China’s State Intellectual Property Office allowed its patent application to provide broad intellectual property protection for the manufacturing and pharmaceutical preparations of retinal pigment epithelial (RPE) cells from hESCs for degenerative retinal disease.

ACT has initiated a Phase I study with the RPE therapy in the U.S. Additionally, ACT has launched human trials for Stargardt macular dystrophy and advanced dry age-related macular degeneration. Data from those trials is expected to be published this fall, after the first three patients are tested in both trials.

Working in Europe

In Europe, Cytori won expanded approval for Celution last year. The sanction included new indications such as breast reconstruction, repair of soft tissue defects, as well as the facilitation of healing certain types of wounds such as those resulting from Crohn disease.

“We’re relatively close, we think, to getting approval for cardiac disease,” Dr. Hedrick added. “And we’re actually beginning to get reimbursement and working toward our own diagnosis-related group payments for the technology in Europe. So that series of decisions, predicated all on the early regulatory approval of the device, has really pushed us down the road of being very active in Europe.”

Cytori sees more potential partnerships among global medical device companies across Europe, particularly in Switzerland, where the company has an office in Zug. Neuralstem is collaborating with Albert-Ludwigs-University in Freiburg, Germany, on a treatment for Huntington disease. It also plans on undertaking a chronic spinal cord injury trial using spinal cord cells being developed at the Czech Institute of Experimental Medicine.

The ability of the European market to grow as a stem cell mecca will hinge, Siegel said, on the outcome of a pending court case that—while different on specifics—parallels the U.S. debate over hESC funding.

Later this year the Court of Justice of the European Union is expected to decide whether to side with its advocate general, who termed stem cell patents “contrary to ethics and public policy,” or with Oliver Brüstle, Ph.D., who since 2004 has fought to maintain a 1997 patent covering methods for deriving neural cells from hESCs despite a challenge from Greenpeace. Dr. Brüstle is director of the Institute of Reconstructive Neurobiology at the University of Bonn.

A decision against Dr. Brüstle would cement Asia’s place on the hESC end of stem cell research and commercialization. The U.S. remains schizophrenic, with President Barack Obama’s administration scrambling to approve new hESC lines, while the Sherley v. Sebelius court case and the nation’s political divide keep federal funding from being a certainty.

Yet all of that doesn’t necessarily hurt U.S. stem cell companies. As the past few years have demonstrated, they are perfectly capable of following the money and partners in pursuit of the science and show no signs of pulling back from their overseas activity.

Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.

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

UM researcher to test stem cell treatment for Alzheimer’s

8:00 pm, May 2, 2010

Results from ALS trials spur optimism
By Ryan Beene And Tom Henderson

http://www.crainsdetroit.com/article/20100502/FREE/305029968/1069

Buoyed by early results of stem cell-based trials on patients with Lou Gehrig’s disease, Eva Feldman, M.D., co-director of the A. Alfred Taubman Medical Research Institute at the University of Michigan Medical School, is now taking aim at a far bigger target: Alzheimer’s disease.

In late April, Feldman began raising $1.5 million from private donors to fund animal trials for a stem cell-based treatment of Alzheimer’s, a progressive degenerative disease that severely impacts brain function and afflicts more than 5.3 million people in the U.S. It is the seventh-leading cause of death in the nation.

Animal trials are required before Feldman can begin Phase I U.S. Food and Drug Administration trials for Alzheimer’s on humans. Tests on both safety and efficacy are done first on small rodents and then, if successful, on larger mammals.

Feldman said she hopes to apply for approval in 2013 for human Alzheimer’s trials and begin them in 2014.

The investigation into an Alzheimer’s treatment piggybacks on current Phase I human trials for patients with Lou Gehrig’s disease led by Feldman that are under way at Emory University Hospital in Atlanta.

The trials test the safety of injecting neural progenitor cells, essentially stem cells that have developed beyond the embryonic phase and are predisposed to becoming nerve cells, into the spinal cords of patients with Lou Gehrig’s disease.

Feldman will continue to serve as principal investigator on that trial — the first FDA-approved trial using stem cells on Lou Gehrig’s patients in the U.S. — as she and her team begin work on Alzheimer’s trials.

Eighteen Lou Gehrig’s patients will be tested in all. The disease, known formally as amyotrophic lateral sclerosis, or ALS, afflicts as many as 30,000 patients in the U.S.

Feldman sped up her timetable for taking on Alzheimer’s after seeing promising early results with three Lou Gehrig’s patients. The first patient was injected on Jan. 19. The third operation, on April 14, was filmed by CNN.

Feldman said she is prohibited from discussing whether patients report such results as increases in strength or sensation. But there have been no ill effects from the three surgeries.

Each patient is injected at five spots on the spinal cord, with about 100,000 cells per injection.

Feldman said she is excited about expanding stem cell trials to Alzheimer’s because of the far larger pool of would-be patients.

The nerves and tissues also are narrowed due to fast delivery cialis http://foea.org/wp-content/uploads/2014/12/FEA-2012-ANNUAL-REPORT-PDF.pdf growing age. It is a serious health concern, which can ruin your generic cialis Visit Website sexual life. 2. However, almost viagra free pill all of them have some limitation of recurrence and certain side effects to affect the female fertility to some degree. By reducing acid production in stomach this not only helps cialis generika 20mg in enlargement of the penis but also treats for lesser ejections and other related erectile issues. “Alzheimer’s is going to be easier to do than ALS,” said Feldman.

She said that the brain can be injected with far more stem cells than the spinal cord, promising greater and faster benefits, and she said the surgery is far less invasive. Instead of needing to remove bone from the back, a tiny hole is cut into the skull in a relatively safe, easy procedure.

The transition from Lou Gehrig’s to Alzheimer’s disease is a natural one because the treatment potentially addresses the same problem. The neural progenitor stem cells work by surrounding specific large nerve cells that are sick and halting further degeneration caused by the disease, Feldman said.

“In the spinal cord, these nerve cells produce the nerve tissue fibers that extend through the muscles of our body, and in the brain, the same type of nerve cell facilitates thinking processes,” Feldman said.

“The kind of stem cells we’re using have a particular proclivity to rescue cholinergic neurons, and it’s cholinergic neurons that degenerate and become diseased in Lou Gehrig’s disease and Alzheimer’s disease.”

The surgeon in the current trials is Dr. Nicholas Boulis, an associate professor at Emory University who was formerly a fellow in Feldman’s research lab at UM.

Boulis specializes in movement disorders, such as Parkinson’s and Huntington’s diseases, and performs about 300 operations a year. He also heads a gene-therapy research lab and is involved in a project that aims to use gene therapy to treat Alzheimer’s.

Boulis said he hopes, if the FDA approves human tests, to do Feldman’s Phase I Alzheimer’s operations, too.

“If Eva thinks we can make progress, I’m her man,” he said.

The Phase I Lou Gehrig’s disease trials are scheduled to finish by the end of June 2011. If they go as hoped, Phase II trials, which assess efficacy, can begin as early as January 2012. Feldman said Phase II trials could add the UM hospital as a test site in addition to Emory.

Investigating a treatment for Alzheimer’s using stem cells is an “interesting approach” and a logical next step to investigate, said Dr. Ken Maiese, professor in the departments of neurology and anatomy and cell biology at Wayne State University Medical School.

“There’s really no good treatment for Alzheimer’s, although there are many trials going on” for drugs that deal with chemicals in the brain related to Alzheimer’s, Maiese said.

But those treat the symptoms, not the underlying issue of rapid brain cell degeneration that is a hallmark of Alzheimer’s.

Maiese cautioned that the science behind a stem cell treatment still has a long way to go, as in any treatment. Going from animal to human trials involves many unknowns.

Feldman said she recently took on a new, young ALS patient, to whom she could, for the first time in her 20 years of treating patients at UM, offer some encouraging words about future treatments.

“For 20 years, there has been little hope I could offer patients. Now there is truly tangible hope. We are truly beginning to try a therapy that can allow us to help halt the progress of this dangerous disease,” she said.

“Patients ask me “what will the future hold?’ I told my new patient, things are extremely hopeful now. The future is very bright. And not just with ALS or Alzheimer’s, but with Parkinson’s and Huntington’s, too.”

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

Download Video Here (Right Click and Save Link As to your computer)

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Posted on

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.