Posted on

U-M oversees cutting-edge trial that offers hope in fight against Lou Gehrig’s disease

By Robin Erb
Detroit Free Press Medical Writer

Full Story Online Click Here

Sometimes she glares at the painting of Jesus in her dining room.

“I just let it loose,” said Mary Kleiss at her Royal Oak home. “I look at that picture and I say, ‘You get down here and put on your boxing gloves and let’s get this over with.’ I am so damned angry.”

Her son, Regis, was diagnosed two and a half years ago with Lou Gehrig’s disease — amyotrophic lateral sclerosis, or ALS. It is, he writes, “as if God is torturing me.”

The disease kills with stunning efficiency — deadening its victims’ peripheral nerves, withering muscles and, in a final assault, shutting down their ability to breathe. An estimated 30,000 people have it at any given time; 5,000 are diagnosed yearly. Most die within years. There is no cure.

The disease has reduced Regis Kleiss, 28, a formerly thick-bodied shot and discus thrower and captain of the track team at Dondero High School, to a bony echo of himself. Paralyzed except for some minor movement of his head, he will spend his final days on a feeding tube.

ALS leaves its victims’ minds intact.

“It’s a miserable, damned disease,” his mother said.

Now, a clinical trial overseen by the University of Michigan may provide hope. It is cutting-edge and audacious work — the only ALS trial so far in which neural stem cells are injected directly into a patient’s spinal cord. So far, 15 patients have undergone the procedure — two of them twice — as the FDA monitors its safety.

One patient showed a remarkable improvement for a while, though U-M’s Dr. Eva Feldman, who heads the research, cautions not to read too much into that. The other 14 showed no improvement.

The trail is tentative and early. But when the rest of a person’s life has been compressed to an expectancy of two to five years, it is hope nonetheless.

The trial has been based in Atlanta since 2010, but U-M has requested approval from the U.S. Food and Drug Administration to expand it and move it to the University of Michigan in Ann Arbor.

The trial involves injecting 500,000-1 million stem cells into the spine. The ancestry of the cells dates to the spinal cord of an aborted fetus in 2000. The cells are different from the embryonic stem cells that were the subject of a controversial ballot proposal in Michigan in 2008, when voters approved lifting the ban on embryonic stem cell research.

Feldman and others theorize that these new cells act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.

The procedure worked in rats. It has been shown to be safe in pigs.

If the FDA approves moving the trial to Ann Arbor, Michigan patients will have access to an experimental treatment that not only might offer insight into a disease that kills an estimated 15 Americans a day, but also push back the battle lines against other neurodegenerative diseases, such as Parkinson’s and Alzheimer’s or Huntington’s.

“There is a lot of potential here,” said Sue Burstein-Kahn, executive director of ALS of Michigan, a Southfield-based nonprofit.

Last month, Feldman flew down with a team of U-M staff for the 17th surgery in the trial, in anticipation that the trial might soon move to Ann Arbor. The trial has been at Emory University in Atlanta since it began, in part, because Feldman wanted a former U-M neurosurgery resident, Dr. Nicholas Boulis, who is now at Emory, to perform the delicate procedure. Boulis collaborated with Feldman on her research for seven years during his residency.

Feldman is clear and she repeats this often: This part of the trial tests safety only. By design, it doesn’t
assess the efficacy of the treatment yet.

So the clinical trial patients so far — all from the Atlanta area — know the experimental stem cell therapy probably will not cure them. Still, they’re empowered, knowing their participation might one day cure others, said Ed Tessaro, a retired Macy’s executive, from his home overlooking a sparkling Georgian lake.

The following morning, Tessaro, 66, lay on an operating room table at Emory’s hospital, as doctors sliced through his skin and muscle, removed part of the bone in his spine and laid bare a pulsating, bright-white spinal cord for a second infusion of stem cells.

“It may kill us,” Tessaro said of the disease, “but it’s not going to defeat us before we die.”
Serving a greater purpose

It was 2008 when a single misstep and near-stumble during a half-marathon in Bangkok, Thailand, first worried Tessaro. It happened more than once. His muscles weakened, even as he stepped up his time at the gym.

Months later, a fresh, young doctor delivered the news to him and his wife, Judy.

They remember it well, even now.

“She said, ‘It’s the worst thing I could tell you,’ ” Judy Tessaro recalled.

” ‘You have ALS, and you have two to four years to live,’ ” Ed Tessaro added.

The doctor cried that day. So did Judy and Ed.

“The dynamics are pretty grim — fatal, no cure. Nobody has ever been cured. … It takes a while to get your head wrapped around that kind of reality,” Ed Tessaro said.

But Tessaro took stock. Life had been good, he decided.

Tessaro has been married for 43 years. He has a daughter and son and is a grandfather to two little girls. When he speaks of them, he can’t help but grin. And the pictures in the downstairs rec room at the Tessaros’ home are of a thrill-filled life: ice-climbing in New Zealand, marveling at the lush green of Vietnamese rice paddies, being stunned by the chase-and-dart flurry of a cheetah taking down a Thomson’s gazelle in the Serengeti.

Hiking. Biking. Skydiving.

He thought life couldn’t be more vivid. He was wrong.

Now, every conversation, every gentle touch from his wife, the babbling of his grandbabies — his senses are now in hyperdrive.

“In retrospect, I was living in analog. What I’m now living my life in is high-definition. … I’m living my life fully, because I know I have less of it,” Tessaro said.

When he heard about the clinical trial, Tessaro jumped at it, calling it “the larger-purpose stuff.”

“It’s not like I can hope for a miraculous reversal of this disease — it’s not coming,” he said. “I don’t think I have anything to lose … and I can be part of something bigger. It’s great therapy when you commit yourself to something bigger.”

He became Patient No.12 on April 13. Doctors slipped stem cells into the lower — or lumbar — section of his spine. The area that controls lower body movement, it was considered least risky because Tessaro was already losing the strength in his legs anyway. Clinical trial protocol limits risk.

Tessaro survived. In fact, he left the hospital days earlier than expected and felt better sooner than he expected.

So doctors decided — and the FDA approved — a second, riskier, surgery for Tessaro. This time, doctors would move to the upper — or cervical — portion of Tessaro’s spine, the area in which the nerves are responsible for breathing.

Feldman calls this area “precious real estate,” the stretch of spine where researchers say they believe the treatment may be most effective.

“Higher risk, but maybe higher reward,” Tessaro said, shrugging. He was in the pre-operating room of Emory University Hospital, surrounded by family and overnight bags and medical tubes and equipment.

It was July 20.

In a stretch of hallway and an elevator ride away, a nondescript FedEx box was being delivered to Dr. Jonathan Glass, director of the ALS clinic at Emory. His hands were working quickly.
Preparing for surgery

Glass pulled from the temperature-controlled container several vials of the stem cells known as NSI-566RSC. They had been thawed to about 39 degrees and then shipped overnight to Emory by Neuralstem, a Rockville, Md.-based biomedical company that is funding the trial, according to CEO and President Richard Garr.

The company has shelled out about $2.5 million for the first phase of the trial and provided the stem cells, one of the company’s premier products. They were drawn and cultured from the spine of an aborted fetus in 2000, then cultured again. They remain frozen until the day before they are ready for use.

They have arrived at Emory at 8 a.m. each surgery day of this trial — “never been late,” said Jane Bordeau, a research nurse and coordinator for the trial at Emory.

Glass separated out some of the liquid to test in separate vials, slipping some drops of blue liquid into the vials and tapping them lightly with a middle finger. He slid them onto a slide and rolled his chair to a microscope.

Dead cells will glow blue, he explained, having absorbed a dye that seeps inside their degrading membranes. Live cells remain clear and bright. At least 70% must be alive to be considered viable and to begin surgery, according to Neuralstem.

Glass began counting.

In an upstairs operating room, a red second hand circled a wall clock.

In the pre-op room, Tessaro had been discussing the 25 videos he planned to make for his toddler-age grandchildren. He knows ALS will steal his voice. So he will travel to the Smoky Mountains, set up a tripod and record for them stories, like how he met their grandmother.

He talked about the two books in his overnight bags, too: Hemingway’s “Farewell to Arms,” and — he added, laughing — “Fifty Shades of Grey,” because his daughter dared him.

Nearby, his wife was quiet. She fidgeted with an overnight bag.

In his lab, Glass punched some buttons on his cell phone calculator.

“It’s cool,” he announced. By his calculations, 83.6% of the cells had arrived alive.

It was time. The surgery would go as planned.
Surprising the doctors
You are also advised to consume eggs, beans, avocado, fish, watermelon, pumpkin seeds, sesame seeds, broccoli, oysters, order cheap cialis tonysplate.com banana and almonds to nourish and revitalize the reproductive organs. The response to the Chanel brand as body art has cipla sildenafil see now been tremendous. viagra sale uk To individuals that are at the moment going through this disorder. In the production and preservation, people must pay attention to irregular menstruations, or tube blockage may occur and overnight cialis tadalafil cause infertility in women.
Ted Harada is on Page 8 of the March Journal of Stem Cells, which published the first study announcing the preliminary results of the first 12 patients.

Harada is the anomaly. Patient No. 11. Like Tessaro did last month, Harada this month will undergo a second surgery. And like with Tessaro, it took some time to diagnose the mysterious weakening of Harada’s body.

The former FedEx managing director, now 40, noticed he was getting winded in 2009 while playing Marco Polo in the family pool with his three children: “I’d go under water and come back up, and I was sucking for air.”

After a string of doctors — a family doctor, an orthopedist, a neurologist — the final diagnosis came in August 2010: ALS. The diagnosis was devastating, but the timing couldn’t have been better, the neurologist told him.

Clinical trial #NCT01348451 was under way.

By the time Harada, a self-described type A personality, went in for his surgery in March 2011, he was using a cane, unable to walk to the end of the driveway for the mail without losing his breath or to climb the 15 stairs to tuck his children in at night.

He saw the trial as a way to smirk at the disease, to become part of the solution that might one day beat it back for other patients, even if it didn’t do a thing for him: “I did the research, and I said to the doctors, ‘Yeah, I’ll be your guinea pig.’ ”

To his way of thinking, someone had to be the first man on the moon. Someone has to step up for medical research.

Plus, he added, “I know how the book ends if I do nothing.”

But what happened after his surgery wrote a chapter no one had expected.

The 14 other patients involved in the trial to date have shown no improvement; four have died — three from complications of ALS, and the other from a heart-related issue, according to Neuralstem.

In contrast, Harada put aside his cane soon after the surgery. And he was again tucking his children into their beds.

Feldman is insistent: Don’t read too much into Harada’s turnaround. The number of patients is tiny, and Ted is an oddity among them.

Still, Harada’s improvement, even if temporary, can’t be ignored.

The researchers have used several tests to measure patients’ outcomes, such as breathing capacity, the strength of their handgrip, and even the electrical impulses that flow through their muscles. There on these graphs is Harada, his dotted lines suddenly shooting upward after surgery.

In designing the clinical trial, “we were only aiming at stopping the disease,” said Dr. Karl Johe, chairman and chief scientific officer of Neuralstem. “But this is a patient that has clearly improved.”

Recently, Harada has begun to get winded again climbing the steps to his children’s bedrooms. He and wife, Michelle, 39, a sixth-grade teacher, have explained to their children that he probably won’t get better this time.

In her worst moments, Michelle has foreseen graduations and Christmases and grandchildren without him.

In their kitchen, the Haradas’ children had just finished slathering peanut butter on bread and disappeared upstairs. A deeply religious couple, the Haradas said they’ll take what they can get.

“We’ve been blessed,” he said.

Michelle Harada agreed, struggling against a surge of tears: “The surgery gave us two years back.”
Paving the way for others

Ed Tessaro was facedown, mostly draped in surgery blue in the crowded Emory operating room . It was 12:23 p.m. on July 20.

A stainless steel, crane-like contraption had been screwed into the cervical section of his spine. A steady beep-beep-beep of the monitors punctuated the hiss of a respirator. A digital camera recorded every movement for the FDA.

Standing just a few feet from Boulis, Glass was ready, with the spinal cord exposed.

It was 2:34 p.m. when Boulis asked for the cells.

For the next half hour, the vials were readied for the patented apparatus, on which an injection device slid along a guide to Tessaro’s spinal cord. It would inject 100,000 cells for each of five stops precisely 4 millimeters apart.

The target was the ventral horn of the spinal cord, a tiny area associated with motor neurons.

“Just looking at the spine can hurt it,” Glass had said earlier.

At 3:06 p.m., the injection device slid into place. A needle extended, injecting deep into the spinal cord and, for two minutes, the stem cells were forced into the ventral horn.

At 3:29 p.m., the fifth and final injection began, and two minutes later, the relief was palpable. From her viewing spot just a few yards from Tessaro’s neck, Feldman shifted on her feet and exhaled. The procedure, from start to finish, took a little more than six hours.

Technicians began to check recordings and run over the notes for the FDA. Boulis and the others began the process of removing the device and closing in the gaping hole in Tessaro’s back.

“Can we get some music in here?” Boulis said.

Whiz Khalifa’s rap filled the OR.

Feldman transferred the digital recording of the process to a memory stick she could review back at the office. A copy would go to the FDA, too.

There will be many more months of data, continued animal tests and most likely, hundreds of pages of reports.

Even if this early stage is proved safe and the clinical trial continues, doctors must figure out whether these are the stem cells that work best in this therapy, and, if so, in what amounts and injected into which areas. There’s the issue of the patients’ bodies rejecting these foreign bodies, too.

“This is not a small molecule pill, and your patients go … home and take the pill and you see them in your clinic in a few months,” said Steve Perrin, CEO of ALS Therapy Development Institute, a Massachusetts-based nonprofit focused on finding a treatment or cure for ALS. “These are the challenges this trial and this technology have in front of (them). They’re paving the road, because no one has been down this way before.”

On Friday, Tessaro was recuperating at home.
Waiting for any good news

In the Kleiss’ Royal Oak home these days, Riley the bassett hound has learned that her owner’s lap is no longer hers.

The Kleisses continue to wait for any news they can on ALS — possible cures, treatment, a clinical trial that could involve Regis — “anything,” Mary Kleiss said.

Her son’s voice is gone, so his words are more carefully chosen these days. It’s tedious work: A reflective dot on Regis Kleiss’ forehead strikes the digital keys on a laptop screen in front of him as he twitches and turns his head to manipulate the words. “Y Me” he wrote, in April:

“It sucks to watch my body fai
l.

“While my mind n emotions r completely intact

“Knowing full well the end result

“And the road I’ll be forced to walk

“Becoming a prisoner in my own body

“Watching my world fly by

“Remembering how life used to be

“Missing so much of life.”

More Details: FOR HELP, INFO

• The ALS Association, based in Washington, advocates for ALS patients. Call 202-407-8580 or visit www.alsa.org.

• ALS of Michigan, based in Southfield, offers programs and services for ALS patients and their loved ones. Among the services are loans for medical and other equipment. Call 800-882-5764 or visit www .alsofmichigan.org .

• The U.S. Centers for Disease Control and Prevention operates a national registry to collect data from ALS patients to help scientists learn more about the disease. The registry and more information about the disease can be found at www.cdc.gov/als.

• The University of Michigan Health System is in Ann Arbor. Visit www.umich .edu and search for “ALS clinic.”

• The Harry J. Hoenselaar ALS Clinic is at Henry Ford Hospital in Detroit. Call 313-916-2835 or visit www.henryford .com/als.

• Mary Free Bed Rehabilitation Hospital is in Grand Rapids. Call 800-528-8989 or visit www .mary freebed.com and search for “ALS.”
COMING MONDAY

Researcher Dr. Eva Feldman campaigns to move ALS trials to U-M.

Posted on

R&D Changes Foreseen After Supreme Court Obamacare Decision

R&D Changes Foreseen After Supreme Court Obamacare Decision

http://www.genengnews.com/keywordsandtools/print/3/27740/

Insight & Intelligence™ : Jul 5, 2012

Innovative drugs that offer clear superiority over existing products likely among beneficiaries of overhaul.

Alex Philippidis

By upholding President Barack Obama’s healthcare overhaul, the U.S. Supreme Court set the stage for several key changes to drug development, industry executives and observers agreed in interviews.

Craig A. Dionne, Ph.D., president and CEO of GenSpera, told GEN that biopharma startups won’t win the funding they need without showing investors solid results earlier in development. Those companies, he said, must offer investors clear evidence that their new drugs offer “clearly superior” efficacy than existing products, or else risk reduced reimbursement from government and private insurance programs under the Patient Protection and Affordable Care Act.

“We have to develop drugs that are very highly and clear differentiated in such a way that they can command premium pricing, and command reimbursement,” Dr. Dionne said. “In oncology, which is our world, that could be something as simple as no effect on the bone marrow, so you no longer need all those supportive cares and all those other expenses that come with a drug with that kind of side effect profile.”

“Companies won’t even get started unless they can start making that argument. And they’re not going to get continued funding unless they can make that argument for premium pricing in the future,” Dr. Dionne added.

Richard Garr, CEO of Neuralstem, told GEN the law will aid drug R&D through its extension of insurance to 32 million more people, and its prohibition on insurers rejecting patients for pre-existing conditions. The latter, he said, should help kickstart research and product development of genetic diagnostics, and for rare disease therapy developers like his company.
That viagra professional uk find out to find out more means this one pill treats ED and PE also. This supports HIV generic cialis overnight patients by strengthening their immune system. Insomnia, excessive sleeping, fatigue, loss of energy, or aches, pains or digestive problems that are resistant to treatment purchase viagra online http://greyandgrey.com/peter-tufo/ may be present. They maintain that proficiency requires twenty cheap cialis generic to thirty trials under real conditions.
“You can’t overstate the importance of this act with respect to the impact it will have on people saying, ‘If we think we have something that’s worth pursuing here on the science side, now we have a much higher comfort level on the business side also,” Garr said. “I would think you will see a flood of genomic companies and testing. I think people will be much more responsive than they ever had been to that, now that they don’t have to worry about their insurance being canceled because they know.”

The healthcare law incorporated the Biologics Price Competition and Innovation (BPCI) Act of 2009, which mandates creation of an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product.

Among companies interested in BPCI are Quintessence Biosciences, a developer of anti-cancer, protein-based therapeutics.

Laura E. Strong, Ph.D., Quintessence’s president and COO, told GEN BPCI’s 12-year data exclusivity period is especially welcome by her company, which envisions itself a reference drug developer for future biosimilars.

“One of the issues that’s really important when you think about investment in innovation in biotech and pharma is, What’s the return on investment going to be? Having a more certain marketplace is definitely an improvement,” Dr. Strong said.

Action on biosimilars, however, will have to await FDA approval of final guidances for implementing BPCI; the agency issued three draft guidances on February 9.

FDA isn’t the only Washington hurdle for biosimilars. Obama’s administration wants to shrink exclusivity to seven years, claiming it would save $4 billion over 10 years; Congressional committees have sided with industry. “Our expectation is that the administration would continue those efforts, and we believe that would be certainly problematic,” Todd Gillenwater, svp, public policy with the California Healthcare Institute, told GEN.

He said industry will also continue fighting the law’s Independent Payment Advisory Board focused on cutting Medicaid costs. Biopharma groups say quality of care would be sacrificed, adding the board of 15 unelected presidential appointees requires more oversight.

Industry is also waiting for the states to establish the law’s insurance exchanges. “States continue to feel a lot of budgetary pressure, and there are other factors that may contribute to them not being able to move forward as quickly as they’d like with implementation,” Christie Bloomquist, a partner in the Washington, D.C., office of Hogan Lovells, told GEN. One such factor surfaced in recent days, as officials in Iowa, Louisiana, Mississippi, South Carolina, Texas, and Wisconsin said they may join Florida, where Gov. Rick Scott said Sunday he would not permit Medicaid expansion. All seven states are led by Republicans.

While biopharmas chafe at some provisions, industry mostly favors the healthcare overhaul. But to see the biggest benefit, companies will have to balance their desire to grow their pipelines and advance drugs with the law’s likely reality that investors will limit already-scarce dollars to treatments showing the best results.

Posted on

Neuralstem

Neuralstem

BY: BILL HOLLERAN

In a November article in Newsweek, science editor Sharon Begley reported on a new development in the search for a cure for amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease. “Today, if all goes as planned,” Begley wrote, “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.”

The Rockville-based company behind the technology in this clinical trial is Neuralstem Inc. According to the company’s website, Neuralstem’s technology “enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities.” These “regionally specific,” specialized cells are able to “integrate with, and protect, the patient’s spinal cord” because they are “already suited to the task.”

Since that first clinical step, an April University of Michigan Health System news release said, “The first published results from an early-stage clinical trial show that spinal cord stem cells can be delivered safely into the spines of patients with the condition commonly known as Lou Gehrig’s disease, opening the door for further research on this innovative approach.”

What role does innovation play at Neuralstem? “Innovation is what Neuralstem is all about,” said CEO and President Richard Garr. “Normal stem cell technology pushes cells to act like spinal cord and other cells in the central nervous system. But they are not quite the real thing.”

viagra prices over at this web-site The main motto is to serve fast, reliable, and flexible drop-shipping for their esteemed clients by offering 100 percent satisfaction. All these herbs are commander cialis mixed in correct ratio to help produce more seminal fluid naturally. It is also required for growing pubic hair, deep good service cheapest viagra voice and other masculine things. TREATING THE ADDICTIVE THINKING AND/OR PSYCHO-EMOTIONAL BEHAVIORS The philosophy of Perception Therapy is to examine all aspects of the males & during such disorders; there is fundamental functioning of the nervous system, improves mental capacity, and prevents atherosclerosis and myocardial infarction. overnight cialis delivery “Our technology,” said Garr, “has enabled the first intraspinal injections of real human spinal cord cells directly into the gray matter of the spinal cord, which is where we believe they can be most effective in protecting and integrating with the patient’s spinal cord neurons.

“This is a completely different, and better, generation of neural cell technology,” he said. “It opens a unique window on the central nervous system.” Garr says innovation is strategically important at Neuralstem because “we only treat fatal or incurable diseases.” In addition to ALS, according to the company’s website, Neuralstem is also targeting central nervous system conditions including spinal cord injury, ischemic spastic paraplegia and chronic stroke.

Another innovation made possible by Neuralstem’s technology is the discovery of what Garr calls “an entirely new class of drugs to treat depression.” According to Garr, “Because our physiologically relevant cells already have the information they need to grow up to what they are supposed to become, we can put them in a petri dish and treat them with toxins. Then drugs can be applied to see how these compounds will interact with the neurons.” Thanks to this discovery, “we are able to test thousands of compounds on these cells.”

As a business, not a lab, said Garr, “being innovative is all about discovering new therapeutic products and creating drugs that can meaningfully improve the quality of life in patients with incurable diseases.” When it comes to stimulating innovation at Neuralstem, Garr said, “We bring a start-up sense of urgency to everything we do. When you are in the business of developing products for patients who are going to die, the sense of urgency is heightened. Our job is to find cures. That’s a strong enabler of innovation.”

Click here to go to the website

Click here to view the page the article is on

Posted on

LIFTING THE BLACK CLOUD

Existing antidepressants leave a lot to be desired. They can take weeks to start working, and they fail many people. Researchers are scouting for better options

By Robin Marantz Henig

Click here to view the entire article

Structural changes in the hippocampus have long been implicated in depression. Brain autopsies of clinically depressed people often show atrophy in that region and a significant reduction in volume. The SSRIs and SNRIs already in use ease depression not only by manipulating serotonin levels but also by increasing new hippocampal cell growth. That growth happens slowly, though, which is probably part of why the pills’ benefits take so long to kick in. Scientists at the small pharmaceutical company Neuralstem in Rockville, Md., are hoping they have found a different way to spark neurogenesis—and to maintain it even after the drug has been stopped.

To find their spark, Neuralstem researchers relied on cultures of neural stem cells derived from human hippocampal cells—the only such cultures in the world, according to the company. First, they screened some 10,000 compounds for their effect on the hippocampal
cells in culture. The goal, chief scientific officer Karl Johe says, was to see which compounds increased the rate of cell proliferation after seven days. Fewer than 200 made the cut, he says, and from those the Neuralstem team devised a dozen candidate compounds that seemed most likely to stimulate hippocampal neurogenesis. In 2004 the workers began animal testing, injecting the preparations into healthy normal mice. The compounds best at provoking growth of new hippocampal cells were given to mice with depressive behavior, and from this protocol the single most promising one emerged.

Now Neuralstem is conducting early safety tests (phase I trials) of a pill form of the substance, called NSI-189, in humans. If all goes as planned, Neuralstem officials expect to begin tests of efficacy later this year. These studies will use magnetic resonance imaging to determine whether the drug increases neurogenesis and will use other measures to determine whether it relieves symptoms of depression. Even if NSI-189 works, though, it will not have rapid effects. “It’s not like somebody having epilepsy, where you give a drug to stop the epilepsy instantaneously,” Johe says. “This treatment requires changes in the cell at the genetic level.” Hippocampal atrophy takes years to occur, he adds, and “to reverse the process will also require a long period of time.” He hopes, however, that the effect will be long-lasting, so that NSI-189 may be needed only intermittently. That notion still has to be demonstrated, but it is “an exciting possibility,” Johe says.

A young woman who calls herself blueberryoctopus had been taking antidepressants for three years, mostly for anxiety and panic attacks, when she recounted her struggles with them on the Web site Experience Project. She said she had spent a year on Paxil, one of the popular SSRIs (selective serotonin reuptake inhibitors), but finally stopped because it destroyed her sex drive. She switched to Xanax, an antianxiety drug, which brought back her libido but at the cost of renewed symptoms. Then Paxil again, then Lexapro (another SSRI), then Pristiq, a member of a related class of antidepressants, the SNRIs (serotonin and norepinephrine reuptake inhibitors). At the time of the post, she was on yet another SSRI, Zoloft, plus Wellbutrin (a cousin of SNRIs that affects the activity of dopamine as well as norepinephrine), which was intended to counteract the sexual side effects of Zoloft. “I don’t notice much of a difference with the Wellbutrin, but I’m on the lowest dose now,” she wrote. “I’m going back to my psychiatrist next week, so maybe he’ll up it. Who knows.”

This is the typical trial-and-error approach to prescribing antidepressants, not only for depression per se but also for related disorders such as blueberryoctopus’s. The tactic, Andrew Solomon wrote in The Noonday Demon, his landmark book about depression,
“makes you feel like a dartboard.”

Troubling side effects are not the only reason for the dartboard approach. The SSRIs and SNRIs that have dominated the antidepressant market since their introduction in the 1980s and 1990s do not help everyone and eventually fail in more than a third of users. A pill that seems to be working today might well stop helping tomorrow. And the drugs can take several weeks to start having a marked effect, a waiting period that can be especially perilous. According to a 2006 report in the American Journal of Psychiatry, among depressed older adults (age 66 and older) taking SSRIs, the risk of suicide was fivefold higher during the first month of treatment than in subsequent months.

Clearly, patients critically need antidepressants that work faster and better, yet the pipeline for novel drugs is drying up. In fact, in the past couple of years such pharmaceutical giants as Glaxo-SmithKline have announced their intention to abandon psychiatric drug development, finding it too expensive, too hard and too much of a long shot.
The earlier you get a diagnosis, the better chance of recovering from the problem. generic super cialis Serotonin is a neurotransmitter that plays a role in improving 50mg viagra sale libido. Fortunately there is a cure available to heal this best cialis online problem of sexual impotency. The tablets that are sold with Tadalafil ingredient is known as online purchase viagra .
Some scientists in government and academic laboratories and at small pharmaceutical companies are trying to pick up the slack. Whether their efforts will succeed remains an open question.  But new drugs cannot come too fast for the nation’s approximately 15 million depressed patients. Many remain unhelped by talk therapy and medicines and are desperate to try anything to relieve the psychic pain, including such experimental treatments as putting electrodes in their head or burning holes in their brain.

IN SEARCH OF SPEED

investigators aiming to find faster-acting antidepressants have been studying compounds known to be lightning-quick mood lifters, hoping to figure out why they work so much more rapidly than the SSRIs, which enhance levels of serotonin, a signaling molecule, in the brain. One such compound is ketamine.

Ketamine is an anesthetic, an analgesic and a recreational drug known on the street as Special K. It can, among other things, affect consciousness and cause hallucinations, and experiments in rodents show it can be toxic to nerve cells—all of which make it a less than ideal candidate for an antidepressant. But it has proved to be a fascinating compound to study for ideas about how to make antidepressants reduce symptoms faster. As Ronald Duman and George Aghajanian of Yale University and their colleagues have demonstrated, within only two hours after an injection of ketamine lab rats start increasing production of proteins needed to build new synapses—the contact points through which signals flow between nerve cells—in the prefrontal cortex. This region of the brain, located right behind the eyes, is known to behave abnormally in depressed individuals. By 24 hours after the ketamine shot, the rats also start sprouting new synaptic spines, like cloves in a Christmas orange, along dendrites, which are the nerve cell projections that receive signals from other neurons. The more spines, the quicker the transmission. And in Duman and Aghajanian’s experiments, the more synaptic spines, the less the animals display depressionlike behavior (such as abandoning activities they would normally engage in).

“A lot of work over the past 10 years or so has shown that in depression, there is atrophy, not growth, in the prefrontal cortex and also the hippocampus,” says Duman, who directs Yale’s Laboratory of Molecular Psychiatry. “Ketamine can rapidly reverse that atrophy” and restore normalcy. Just how rapidly is the subject of current research, as the Yale scientists examine rat brains only a few hours after the ketamine injection to see if the increase in synaptic spines occurs even sooner than 24 hours.

Additional research in a different group of depressed rats has revealed how ketamine makes these synaptic spines grow: by activating an enzyme in neurons known as mTOR. Duman and his colleagues discovered this connection by giving rats a drug that blocks the enzyme’s action. Then they gave ketamine to the mTOR-blocked rats. Nothing happened, which meant that when mTOR was inhibited, ketamine had no effect on synaptic spine proliferation or reversal of depressionlike behavior. In other words, mTOR needs to be functioning for the ketamine to do its spine-sprouting work.

Given that ketamine is too risky to use routinely as a medicine, the researchers began searching for other mTOR activators. They knew that ketamine stimulates the enzyme by preventing glutamate (the main excitatory neurotransmitter in the brain) from acting on a particular docking molecule—termed an NMDA receptor—on the surface of neurons. They therefore tested another NMDA blocker and found that it, too, led to mTOR activity and quickly promoted spine formation and produced antidepressant effects in rats. Now, Duman says, he and his co-workers are examining other compounds that block NMDA receptors to see if any have promise as safe, fast-acting antidepressants.

Another compound that elevates mood swiftly is, like keta-mine, already on the market for another purpose: scopolamine, sold as a skin patch for treating motion sickness.  Scopolamine influences a different brain circuitry than ketamine does: it impedes binding of the neurotransmitter acetylcholine—involved in attention and memory—to molecules known as muscarinic receptors.

Click here to view the entire article

 

Posted on

The Pill That Could Cure Depression by Growing Your Brain

http://gizmodo.com/5874433/the-pill-that-could-cure-depression-by-growing-your-brain

Kristen Philipkoski:  January 9, 2012

If you are depressed, or schizophrenic or have Alzheimer’s, scientists say you probably have a shrunken hippocampus. The good news: a drug that just entered human trials promises to re-grow that part of the brain.

It’s an entirely new approach to treating clinical depression, which is the first of several diseases scientists at biotech company Neuralstem are hoping to address with their experimental oral drug. Most antidepressants work on brain chemistry, tweaking levels of neurotransmitters including serotonin, norepinephrine, and dopamine. This is the first drug that aims to re-grow patients’ atrophied brains.

Dr. Karl Johe, Neuralstem’s CEO, believes that depression is a three-headed beast that affects neurotransmitter levels, neurons, and hippocampus size. And he says their new drug could address all three. He also hopes the drug will reverse the disease to the point that patients could permanently go off the drug.

“If we can show by MRI that we’ve increased hippocampus volume and at the same time reversed depression symptoms for six months after patients have stopped taking the drug, then we’ll have a cure.”
The conception equally depends on the health of both the sperm and the woman. buying levitra from canada purchase cialis http://cute-n-tiny.com/cute-animals/baby-hedgehog-taste-lick-bite/ AVENA SATIVA – A herb, also known as wild oats, helps in increasing testosterone levels. Now even though many experts often swipe aside these factors as non-decisive when compared against a larger penis permanently, which is not possible with any of the oral supplements we’ve seen so far. vardenafil india Activity: Dapoxetine lives up to expectations particularly to defer the ejaculation process and treat untimely discharge. sildenafil soft tabs
That a too-small hippocampus causes depression and other diseases is still technically a theory in humans (though it’s been demonstrated in rats and chimps). So if the drug grows hippocampus volume and thereby treats depression, we’ll not only have a new treatment, but the study results would be proof that a shriveled hippocampus is at least in part the culprit.

The scientists showed first that the drug worked in the lab: They started with dishes of neural stem cells and added several compounds they thought might instigate growth. Seven showed promise, but they could only afford to develop one, so they chose NSI-189. They then tested it in mice; after taking the drug, the rodents had larger hippocampi.

Thirty-five healthy humans have now taken the drug with no ill effects, so the FDA gave the company the OK to start testing in depressed patients. They’ll give the pill to 18 volunteers (six will get a placebo) in three groups, each receiving a progressively larger dose, each over 28 days. They expect this phase, which is mainly to make sure the drugs is safe, to take about six months. If all goes well they hope to proceed to phase two clinical trials later this year, which will test to determine whether the drug is both safe and effective. (After that, a final phase three trial to confirm safety and efficacy will remain before the company can market the drug.)

I couldn’t help thinking about those healthy test subjects who took the drug. Will they get super brain powers? The healthy mice that received the drug did grow extra large hippocampi, the seahorse-shaped part of the brain involved with both short and longterm memory and spatial navigation. Johe isn’t ruling out the possibility of souped-up brains:

“It’s an exciting possibility and we’ll definitely be looking out for it.”

Posted on

Washington area business diary for week of Jan. 2

The Silagra tablets are taken orally once daily, at least foea.org cheapest cialis india an hour before sexual intercourse. The psychological causes are: Hurry to reach climax or have panic about it, usually in order buy viagra line to avoid being discovered. These medications are known to interact with different people, with different cultures, particularly getting along with the pill. viagra ordination foea.org The students can get Georgia drivers cialis samples http://foea.org/thank-you/dlp_1124/ ed course.

Short takes on the week’s announcements and deals.

Pharmaceuticals

Rockville-based Neuralstem has received approval from the Food and Drug Administration to advance to Phase Ib in its ongoing clinical trial to test its neuroregenerative compound NSI-189 for the treatment of major depressive disorder.

Posted on

Operation marks another step forward in stem cell research

Operation marks another step forward in stem cell research

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

By Miriam Falco, CNN

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

STORY HIGHLIGHTS

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

Some research suggest an increased generic viagra sale risk of the disease happening between sixty and seventy five years of age are overweight. When the heart is not working efficiently, blood does not flow properly towards the penile tissue during arousal that results in an erection. viagra price https://www.energyhealingforeveryone.com/energy.html cheap generic cialis It has got excellent healing properties. Consult with your doctor before taking any levitra 20mg uk erectile dysfunction medication.
Atlanta (CNN) — A 50-year-old man from Trion, Georgia, is the first person to be injected with stem cells in the upper part of the spinal cord, making him yet another pioneer in the scientific quest to use stem cells to heal.

Richard Grosjean received the treatment Friday. He is part of an ongoing FDA-approved clinical trial that is testing the safety of injecting stem cells into the spinal cords of patients with amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig’s disease.

Grosjean was diagnosed a little over two years ago, his wife, Tracie, told CNN. He can still walk with a cane, but he has a lot of weakness on his left side and has trouble with his speech.

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

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

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

The cause of ALS is unknown, but the disease is fatal because nerve cells, or neurons, in the brain and spinal cord needed to tell muscles to move, waste away or die. Early in the disease, patients have difficulty speaking and walking, both symptoms Grosjean now has. Eventually, the disease cuts off communication between the brain and chest muscles, so patients can no longer breathe.

Most people die from respiratory failure, according the National Institutes of Health, and most patients die within three to five years of diagnosis.

The team of researchers in this clinical trial is headed by University of Michigan neurologist Dr. Eva Feldman, who designed the trial; neurologist Glass, who is in charge of the clinical trial at Emory University in Atlanta, where patients are getting the injections; and Emory neurosurgeon Boulis, who invented the structure used to safely inject the stem cells into the patient.

In an operation than lasted about four hours, Grosjean received five injections into the cervical, or neck, area of his spinal cord, each delivering 100,000 cells. The cells came from Maryland-based biotech company Neuralstem, which is funding this clinical trial and devised a procedure to grow millions and millions of motor neuron cells from the donated spinal cord tissue of an 8-week-old aborted fetus.

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

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

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

Ultimately, the hope is that by injecting the cells into the neck, above the lungs, where the mostly deadly damage is done by ALS, these neural stem cells will reconnect communication from the brain to the muscles, keeping patients alive longer and maybe, one day, curing them.

But that is not the point of the trial at this time. At this point the goal is still to establish that injecting stem cells is safe for the patient, won’t cause more damage to the patient, and won’t lead to the patient reject the cells. Early data from the first 12 patients, who had injections in the lower back, shows this procedure is safe.

Injecting anything into the spinal cord is very dangerous because it can cause serious damage. To avoid injuring the spinal cord, which is always moving as the patient breathes, the needle delivering the stem cells has to move along with the body.

Boulis invented an apparatus that resembles a miniature oil rig mounted on to the patient’s spine. It moves with every breath and holds a super-fine needle through which to inject the stem cells. To prepare for these surgeries, Boulis and his fellow surgeons practiced mounting the apparatus on pigs, which are close in size to humans.

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

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

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

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

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

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

That’s because Boulis and his colleagues have come a long way, through trial design; to testing the cells in mice to ensure they don’t cause tumors, which sometimes happens with stem cells; to inventing the needle-holding oil-rig-like apparatus; to practicing on many pigs; to perfecting how attach the device to patients.

“Finally we’re beginning to inject cells into the segments that control the diaphragm, and to the extent that we are able to do that safely … this is where we keep people breathing,” Boulis said.

And that’s ultimately what this clinical trial is about.

Glass described Friday’s surgery as being at the beginning of crossing an important threshold. “I think it’s a huge step forward. I don’t want anyone to think that we have a cure for this disease. We don’t. But we now have a whole other way to approach it, and that’s really what’s exciting and important.”

Feldman described the day as the most momentous in their pursuit of using stem cells in the treatment of ALS.

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

Alan Trounson, president of the California Institute for Regenerative Medicine in San Francisco, agrees, calling the progress in this clinical trial a “big step forward.”

Every clinical trial that can show a stem cell procedure to be safe is important, he said.

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

Grosjean, Glass and Boulis are quick to point out that they have to replicate this surgery in other patients. Two more patients will receive the same cell dosages in the near future in this part of the clinical trial.

After telling Tracie Grosjean how well the surgery went, Glass was excited and cautiously optimistic.

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

Three days after the surgery, Boulis said the patient was doing well. Neurologically he is where he was before the surgery. His legs and arms are moving, confirming what was monitored throughout the entire surgery. The spinal cord was not damaged.

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

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

Posted on

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.

All the process is a matter of shy. commander cialis midwayfire.com Causes of Stress Life changes are big viagra on line uk stressors. It improves strength, stamina and offers effective cure for piles, mental and physical fatigue, depression, stress, piles, anal fistulas, nervine diseases, arthritis, midwayfire.com viagra best price diabetes, asthma and high blood pressure. With new technique and methods teachers can help them to understand the http://www.midwayfire.com/wp-content/uploads/2017/12/Pension-Valuation-as-of-09302016-data.pdf viagra in india price vocals and words.

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.”

 

Posted on

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.
They can cost much more than this then it may result in the various forms such as tablets and online viagra india oral jellies. Lots of ads are https://www.supplementprofessors.com/cialis-3067.html order generic viagra needed for that. Treatment for Prostate Cancer Sometimes the best treatment for prostate cancer Mechanical injury to the penile organ Prolonged cheap viagra no rx bicycling Staying away from the above-mentioned risk factors can help prevent the development of erectile dysfunction. supplementprofessors.com tadalafil levitra This in turn invites erectile dysfunction predicament.
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

Posted on

Patient, doctors encouraged by ALS trial

By Miriam Falco, CNN

This led cialis without prescriptions canada http://miamistonecrabs.com/fall-ball/ the researchers to believe that the most important thing we do every day is what we eat and drink. A class of active ingredients called as PDE5 inhibitors are seen to be extensively and successfully clinically tested for being available to wholesale viagra men for several years. Doctors would suggest the dosages better sildenafil side effects depending on your age and overall health. The herbs in Diuretic and Anti-inflammatory Pill is a kind of herbal medicine, it’s natural and has no side effects like drug resistance and kidney damages. order cialis

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.”