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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.

  • Alex Philippidis

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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.

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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.”

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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.”

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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.

Posted on

Election to benefit some industries, harm others

Election to benefit some industries, harm others

By CHRISTOPHER S. RUGABER

November 3, 2008
AP Economics Writer

WASHINGTON (AP) — Battered by the financial meltdown, America’s business community is anxiously calculating how Tuesday’s presidential election will affect it.

Energy, pharmaceutical and telecommunications companies could face tax and other policy changes no matter who wins the White House. The outcome also could determine how well alternative energy developers, generic biotechnology companies, stem cell researchers and others fare.

Labor unions put major resources behind Democrat Barack Obama and could wind up a big winner if he takes the White House. Nuclear power and the coal industry would get a boost if Republican John McCain prevails. Obama promises to raise corporate tax rates and income taxes on families making over $250,000; McCain promises to cut corporate taxes and extend all of President Bush’s tax cuts.
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A look at how some could fare:

STEM CELL RESEARCH

Few sectors have more to gain on Election Day than the nation’s fledgling stem cell companies, which long have bemoaned the administration’s policy limiting federal money for embryonic stem cell research. Bush believes the research is immoral because the process of culling the stem cells kills the embryo.

Both Obama and McCain support federal spending on stem cell research and could move to overturn current restrictions. Industry executives say the policy change would shore up investor confidence in stem cell developers.

“It will relieve a lot of uncertainty among the investment community that we are going to become an outlaw industry,” said Richard Garr, chief executive of Neuralstem.

Posted on

Neuralstem’s cells reverse paralysis

Published: May 30, 2007 at 11:10 AM

Neuralstem’s cells reverse paralysis

ROCKVILLE, Md., May 30 (UPI) — U.S. firm Neuralstem said Wednesday its human spinal stem cells reversed paralysis in a rat model of a spinal disorder.

The company, which said the finding has significant implications for humans because the condition the rats suffered from also afflicts people, plans to file an investigational new drug application later this year.
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In the study, which is published online by the journal Neuroscience, three rats paralyzed from ischemic spastic paraplegia returned to near normal function six weeks after receiving Neuralstem’s human spinal stem cells.

Three other rats did not regain the ability to stand up but showed significant improvement in the mobility of their joints and muscle tone.

Ischemic spastic paraplegia, which is characterized by extreme spasticity and rigidity that leads to paralysis, sometimes results in humans following surgery to repair aortic aneurysms.

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Stem cells delay paralyzing disease

Stem cells delay paralyzing disease
Mon Oct 16, 2006 3:08 PM ET

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) – Human fetal stem cells can graft onto the spines of rats and delay some of the paralyzing symptoms of motor neuron disease, commonly known as Lou Gehrig’s disease, U.S. researchers reported on Monday.

The new cells were resistant to the disease, also known as amyotrophic lateral sclerosis or ALS, the researchers said.

A company associated with the researchers is incubating batches of the human cells, taken from an aborted fetus, and hopes to market them as a treatment for several sorts of paralyzing conditions.

“We were extremely surprised to see that the grafted stem cells were not negatively affected by the degenerating cells around them, as many feared introducing healthy cells into a diseased environment would only kill them,” said Dr. Vassilis Koliatsos of Johns Hopkins University, who helped lead the study.

The researchers, who published their findings in the journal Transplantation, used specially bred rats that always develop symptoms of ALS and die. Like people with the disease, they gradually become paralyzed until they suffocate when breathing muscles stop working.

There is no cure for ALS and the causes are not clear. But the Johns Hopkins team wanted to see if grafting new cells into the body might help preserve some muscle function.

They used cells taken from an 8-week-old fetus, which had been donated by the mother after an abortion. Stem cells are partially developed but can give rise to a variety of different tissues if put into the right environment.

The cells from the aborted fetus are not the same as embryonic stem cells, currently at the center of a political debate in the United States. Fetal stem cells are intermediate between embryonic stem cells and so-called adult stem cells.

 
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They are somewhat more malleable than adult stem cells but not as plastic as embryonic stem cells.

In this case, the researchers took the cells from the developing spine. These cells are already destined to become nervous system tissue and do not elicit an immune rejection by the body, said Karl Johe, chairman and chief scientific officer of Neuralstem Inc. in Rockville, Maryland.

NO CURE

The researchers only transplanted cells into the lower spinal cords of the rats, in part because the animals are so tiny and the job is tricky, said Johe. Because the upper spinal cord controls the upper half of the body including breathing, there was no chance of curing the rats.

“They do develop symptoms and also they still die, but the onset is more slowly developing and the longevity is extended,” Johe said in a telephone interview.

They injected the human fetal stem cells into adult rats not yet showing symptoms and also killed some of the stem cells and injected them into other rats to act as a control.

On average, the rats treated with live stem cells started losing weight — one of the first symptoms of disease — after 59 days and they lived for 86 days. In contrast, the rats given the sham treatment started to lose weight at 52 days and only lived for 75 days.

While all the rats grew steadily weaker, the treated rats maintained their ability to crawl up a slope for much longer than untreated rats.

After the rats died the researchers examined their spines and saw that 70 percent of the transplanted cells had developed into nerve cells.

Johe said the company was growing and nurturing the cells and hoped to create many batches of purified cells that could be used for transplants for a range of patients with spinal cord diseases or injuries.

“If we see in a year … really significant effects (in rats) then I think we could be ready for a (human) clinical trial in another year after that,” Johe said

Posted on

Stem cells delay paralyzing disease

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Stem cells delay paralyzing disease
Mon Oct 16, 2006 3:08 PM ET

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) – Human fetal stem cells can graft onto the spines of rats and delay some of the paralyzing symptoms of motor neuron disease, commonly known as Lou Gehrig’s disease, U.S. researchers reported on Monday.

The new cells were resistant to the disease, also known as amyotrophic lateral sclerosis or ALS, the researchers said.

A company associated with the researchers is incubating batches of the human cells, taken from an aborted fetus, and hopes to market them as a treatment for several sorts of paralyzing conditions.

“We were extremely surprised to see that the grafted stem cells were not negatively affected by the degenerating cells around them, as many feared introducing healthy cells into a diseased environment would only kill them,” said Dr. Vassilis Koliatsos of Johns Hopkins University, who helped lead the study.

The researchers, who published their findings in the journal Transplantation, used specially bred rats that always develop symptoms of ALS and die. Like people with the disease, they gradually become paralyzed until they suffocate when breathing muscles stop working.

There is no cure for ALS and the causes are not clear. But the Johns Hopkins team wanted to see if grafting new cells into the body might help preserve some muscle function.

They used cells taken from an 8-week-old fetus, which had been donated by the mother after an abortion. Stem cells are partially developed but can give rise to a variety of different tissues if put into the right environment.

The cells from the aborted fetus are not the same as embryonic stem cells, currently at the center of a political debate in the United States. Fetal stem cells are intermediate between embryonic stem cells and so-called adult stem cells.

 

They are somewhat more malleable than adult stem cells but not as plastic as embryonic stem cells.

In this case, the researchers took the cells from the developing spine. These cells are already destined to become nervous system tissue and do not elicit an immune rejection by the body, said Karl Johe, chairman and chief scientific officer of Neuralstem Inc. in Rockville, Maryland.

NO CURE

The researchers only transplanted cells into the lower spinal cords of the rats, in part because the animals are so tiny and the job is tricky, said Johe. Because the upper spinal cord controls the upper half of the body including breathing, there was no chance of curing the rats.

“They do develop symptoms and also they still die, but the onset is more slowly developing and the longevity is extended,” Johe said in a telephone interview.

They injected the human fetal stem cells into adult rats not yet showing symptoms and also killed some of the stem cells and injected them into other rats to act as a control.

On average, the rats treated with live stem cells started losing weight — one of the first symptoms of disease — after 59 days and they lived for 86 days. In contrast, the rats given the sham treatment started to lose weight at 52 days and only lived for 75 days.

While all the rats grew steadily weaker, the treated rats maintained their ability to crawl up a slope for much longer than untreated rats.

After the rats died the researchers examined their spines and saw that 70 percent of the transplanted cells had developed into nerve cells.

Johe said the company was growing and nurturing the cells and hoped to create many batches of purified cells that could be used for transplants for a range of patients with spinal cord diseases or injuries.

“If we see in a year … really significant effects (in rats) then I think we could be ready for a (human) clinical trial in another year after that,” Johe said.