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Spinal gap: Neuralstem goes into chronic injuries phase I trial first ever to be cleared by the FDA

click here to read the full article

By Randy Osborne, Staff Writer
With encouraging data from a phase I trial in amyotrophic lateral
sclerosis (ALS) and a phase II trial under way testing NSI-566,
Neuralstem Inc. has begun – with the same candidate – the fi rst
human neural stem cell study to be given the FDA’s nod for chronic
spinal cord injury.
Four patients with thoracic spinal cord injuries (T2-T12) will
have NSI-566 transplanted directly into the region of the injury,
which has been sustained between one and two years before the
treatment. All patients have an American Spinal Injury Association
grade A level of impairment, which means complete paralysis with
no motor or sensory function at and below the trauma site.
Richard Garr, CEO of Germantown, Md.-based Neuralstem, said
the trial is half the size originally planned, and for a good reason.
“When we submitted this originally, there were eight patients, but
that was before we had treated successfully the high-dose patients
in our ALS trial,” he told BioWorld Today. “We went back to the FDA
and asked them to amend the protocol.”
Last heard from in the stem cell/spinal cord injury space was
Menlo Park, Calif.-based Geron Corp., which last year disclosed in
an SEC fi ling that the assets related to the program were taken
over by Asterias Biotherapeutics Inc., a subsidiary of regenerative
medicine specialist Biotime Inc., of Alameda, Calif.
The deal involved transfers of common stock and warrants, along
with patents, regulatory fi lings and investigational new drug
applications fi led with the FDA for Geron’s phase I safety study
with the oligodendrocyte progenitor cells (OPCs). Geron was
investigating the cells’ effi cacy in acute spinal cord injury, rather
than chronic, as with the Neuralstem product. In May of this
year, Asterias offered promising safety results with AST-OPC1, a
population of cells derived from human embryonic stem cells
that contain the OPCs, in fi ve subjects tested during a restarted
experiment that Geron began in 2010. (See BioWorld Today, Jan.
26, 2009, Jan. 27, 2009, and April 5, 2013.)
This no prescription cialis oral prescription is fundamental to impotent men. It is the dildo on this toy that helps you penetrate 100mg viagra for sale http://www.daveywavey.tv/levitra-5296.html your man. This condition is called priapism, and, while quite rare, can happen with buy generic cialis http://www.daveywavey.tv/30days/ the use of some ED drugs. Stroke -harsh condition, which sildenafil tablets encounter when the blood circulates in direction of the brain get intermittent. “It’s hard,” Garr said of the research. “For something like this, the
FDA won’t just let you go in to try. The surgery is very risky. We’re
the first ones who ever did intraspinal injections with our ALS trial.”

Neuralstem had to use a special delivery device invented
at Cleveland Clinic, and deliver strong preclinical data
to U.S. regulators before efforts could move ahead. The
fi rm’s approach is “very different from what anybody else,
even Geron, has ever done,” he said.
Predicting how fast benefi t might appear is tricky. “In ALS
patients, the maximum window of biological activity for
the cells was between four and six months post-surgery,”
Garr said. “But it was also very clear in four to eight weeks
that there was considerable biological functional activity.
Will we see that in spinal cord patients? We don’t know,
but that would be our expectation.”
For some ALS patients, the effects turned up much sooner,
he added. “What the cells are doing here, in chronic
[spinal cord injury] patients, is literally bridging the gap.
We’re trying to rebuild the circuitry in the gap so that the
signal can come through, down the spinal cord. There are
also a lot of neurotrophic factors expressed by the cells
that can help with healing, but in a chronic patient, it’s
unknown how much impact that will have.”
Garr cited a key difference between spinal cord injury and
ALS, “where you are putting the cells in the motor neuron
pools to protect and nurture the remaining motor neurons
and then hopefully nurture back to health those that
haven’t hit that tipping point. The early neurotropic factor
expression of the cells, even before they are synaptically
integrated and matured, could have an effect [in ALS] –
clearly has. Maybe in spinal cord injury patients, where the
neurotrophic effect isn’t the primary reason for benefi t,
it could take a little longer. We’re really waiting for the
synaptic connections to happen and for the circuitry to be
rebuilt.”

 

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New trial may be step forward for spinal cord injuries

http://thechart.blogs.cnn.com/2014/04/16/new-trial-may-be-step-forward-for-spinal-cord-injuries/?iref=allsearch

April 16th, 2014

Miriam Falco – CNN Medical Managing Editor

New trial may be step forward for spinal cord injuries

In what may be another step forward in treating spinal cord injuries, a safety trial will begin this year on the practice of injecting stem cells directly into the injury site, Neuralstem Inc. announced Wednesday.

The Maryland company said the University of California, San Diego’s Institutional Review Board had approved its clinical trial protocol, which also has approval from the Food and Drug Administration.

The first eight patients who will be enrolled will be paraplegics who had a thoracic spinal cord injury one to two years ago and have no motor or sensory function below the point of their spinal cord injury.

Thoracic spinal cord injuries are rare, according to the Christopher and Dana Reeve Foundation, because of the protection afforded by a person’s rib cage. In addition to the loss of function in legs, patients also experience a loss of physical sensation, bowel and bladder problems and sexual dysfunction. However, in most cases, function of the arms and hands are not affected.

It’s the latest trial designed to inject stem cells into patients’ spines. The trial is supposed to show that the drug – stem cells, in this case – is safe, although researchers hope to provide some benefit as well.

In 2009, California-based Geron Corp. not only injected the first stem cells into a patient’s spinal cord, it was the first to use the highly controversial derivative of human embryonic stem cells. But after treating at least four patients, the company chose to shut the trial down in 2011 because of its expense and the company’s focus on cancer research.
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One week later, Neuralstem began its clinical trial in patients with amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig’s disease. That trial used a new device to inject stem cells into the spine without causing additional injury to the spinal cord. Neuralstem’s cells are not embryonic stem cells but rather cells taken from fetal spinal cords, which have already started to become nerve cells.

New Jersey-based StemCells Inc. launched spinal cord trials in Switzerland in 2011, using its own type of neural stem cells also derived from fetal tissue. It injected its first North American patient in Canada this year.

Unlike the goal of the Geron trial (similar to StemCells’), which was to re-mylenate nerve cells to re-establish connections from the spine to the brain – like fixing an exposed wire by providing a new cover – the goal in this new trial is to “actually build new circuitry,” Neuralstem CEO Richard Garr said.

“The stem cells are injected directly into the area of the injury and jump the gap with the new circuitry we’ve built,” he said. “These cells don’t migrate to the site.”

In animal experiments, rats were injected with these human stem cells and recovered significant function in all lower extremity joints, according to Neuralstem. “The cells turned into neurons which grew a ‘remarkable’ number of axons that extended for ‘very long distances,’ bridging above and below the point of severance,” the company says in a statement, quoting study results from August 2012.

Neuralstem is trying to reconnect the nerve cells from below the injury site to cells above the point of injury to re-establish signals going to the brain, says Karl Johe, the company’s chairman and chief scientific officer, who developed the cells.

Johe says he hopes the first patient will have the surgery to get the stem cells by July. “And then it would occur about once a month,” he added.

As for the most recent research, which discussed a much simpler method called epidural stimulation, Johe says it’s a complimentary approach. This month, researchers showed that four patients who had had spinal cord injuries for more than two years were able to ‘reawaken’ their muscles, so to speak: move their legs when electrodes implanted in the back were turned on, providing electrical stimulation to the spinal cord.

“There has been debate whether the motor neuron circuitry is intact below the injury point,” Johe said. “So now we know for sure (it is).”

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Neuralstem’s $19.6M offering takes ALS bid through phase II

By Randy Osborne, Staff Writer
Neuralstem Inc.’s $19.65 million from a stock offering will help
advance the lead compound NSI-566 in amyotrophic lateral sclerosis
(ALS), which is “about halfway through” a Phase II trial, said CEO
Richard Garr.
Rockville, Md.-based Neuralstem is selling about 6.7 million shares
at $2.91 each in the offering. Each investor also gets a warrant to
buy half the number of shares purchased. Warrants bear an exercise
price of $3.64, and can be exercised for fi ve years.
Shares (NASDAQ:CUR) closed Friday at $2.97, down 19 cents.
Expected to close next week, the offering’s proceeds will get
Neuralstem through Phase II in the ALS effort with spinal cordderived
stem cells, as well as the small-molecule program, where
the company has “just completed a Phase Ib trial in major depressive
disorder,” Garr told BioWorld Today. “We’re looking at the data now,
and anticipate sometime in this quarter fi ling for a Phase II.”
Stem cell trials are neither much more expensive nor much cheaper
than tests of other therapies. “That’s always in the eye of the
beholder, isn’t it?” Garr noted. “Drug trials, especially for depression,
are expensive. Everybody knows what the FDA expects and what the
parameters are. It doesn’t cost us any more or any less than anybody
else.”
Cell therapy as a whole is “fairly expensive,” he said. “In terms of the
dollars per patient, it’s very expensive, but in terms of the numbers
of patients, because it’s fairly small, the overall cost is manageable.”
The Phase II trial in ALS got funding help from the National Institutes
of Health and from the ALS Association, he said.
“We have to wait six months after the last surgery for the trial to
end,” Garr said. “Sometime near the end of this calendar year, the
Phase II [in ALS] should be over completely.”
Neuralstem’s approach represents the world’s fi rst intraspinal
injections of stem cells. “This is a targeted surgery at various
segments of the spinal cord, and the cells actually go into the
motor neuron pools in those segments and synaptically integrate,”
Garr said. “There have been, in the past, people who have tried to
put what you would think of as adult stem cells – all kinds of bone
marrow and blood stem cells and things like that – into the spinalfl
uid cavity,” though such experiments took place “mostly in Mexico
and in Germany and other places,” as well as China, he said.
“Our approach is unique, actually rebuilding the circuitry,”
Garr said. “These cells don’t fl oat up and down in the spinal
fl uid, and they don’t migrate to the spinal cord. They’re going
in and creating new circuitry inside very specifi c segments
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groups of muscles, he noted. In ALS patients, when the
muscles that control breathing and swallowing give way, so
do the patients, not long afterward.
HUMAN DATA FUELING STOCK
Neuralstem also has been given clearance by the FDA to
start a spinal cord injury trial in complete paralysis patients,
using the same technology.
“Geron, of course, famously, had an approval from the FDA
[for trials] with their oligodendrocyte progenitor [GRNOPC-1]
cells to try to treat spinal cord injury,” Garr said. “I believe
they may have actually transplanted two or three patients
before they pulled the plug.”
Menlo Park, Calif.-based Geron last April disclosed in an SEC
fi ling that the assets related to the program were taken over
by Asterias Biotherapeutics Inc., a subsidiary of regenerative
medicine specialist Biotime Inc., of Alameda, Calif. The deal
involved transfers of common stock and warrants, along
with patents, regulatory fi lings and investigational new drug
applications fi led with the FDA for Geron’s Phase I safety
study with the cells. (See BioWorld Today, Jan. 26, 2009, Jan.
27, 2009, and April 5, 2013.)
“The mechanism of action by the cells, even though it’s the
same cells, is a little different [in spinal cord injury, where]
the idea is literally to build new circuitry to bridge the gap,
to bring function back to paralyzed patients,” Garr said. “In
ALS, even though patients lose their ability to walk, it’s not
because there’s a break in the signal coming down the spinal
cord from the brain. It’s because the muscles have atrophied
and died. Our main goal here is to improve the quality of life
and extension of life for these patients, is to keep them off
breathing machines for as long as possible.”
Neuralstem’s shares have been on the climb for about a
year. ”We don’t really talk about the stock that much,”
Garr said, because market changes are too hard to explain,
in most cases. “The clear answer is, there’s no substitute
for human data,” and interim data have been showing up in
presentations.
“A publication is coming out, we expect, on the Phase I trial [in
ALS],” he said. “Some of the patients went public, and it was
in Newsweek. It was pretty clear, just from a lay perspective,
they were seeing a defi nite benefi t to a number of patients, and
long term, not just marginal but signifi cant, quantitative actual
improvement that no one has seen before, and that has lasted
a very long time.”

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Human Stem Cells Help Acute SCI Rats; Chronic Trial Update

http://www.spinalcordinjury-paralysis.org/research/2013/05/31/human-stem-cells-help-acute-sci-rats-chronic-trial

Human Stem Cells Help Acute SCI Rats; Chronic Trial Update

Posted by Sam Maddox
Friday, May 31, 2013

A study was published this week showing that rats improved function after receiving transplants of Neuralstem, Inc.’s human neural stem cells three days after a spinal cord contusion injury (at L3). The study, “Amelioration of Motor/Sensory Dysfunction and Spasticity in a Rat Model of Acute Lumbar Spinal Cord Injury by Human Neural Stem Cell Transplantation,” was led by Martin Marsala, M.D., of the University of California, San Diego (UCSD) School of Medicine.

The human cells in this experiment — they call them NSI-566 cells — are derived from a single, legally aborted fetus; these are the same ones used by Neuralstem in 15 patients in an ALS safety trial. They are also the same ones set for clinical trial in chronic SCI, which we will get to in a minute.

In all cases, the cells are injected into the exposed spinal cord in several locations; so far, they appear to be safe. For the ALS trial, the company reported earlier this month that the procedure “was found to be safe, well-tolerated, and promising for other spinal cord conditions.”

The company also notes that some of the patients benefited from the cell transplants. A 39-year-old man with ALS, Ted Herada, got two sets of stem cell transplants. After the first, in 2011, he was recovered a meaningful degree of function, then declined. A year later, he got more cells. Neuralstem reports that Ted recently completed 2.5 -mile fundraising ALS walk in Atlanta, “still going strong past finish line.”  He is “Living a normal life: walking, climbing stairs, hands stronger again, increased dexterity.”

Says Principal Investigator Eva L. Feldman, M.D., University of Michigan, from a release, “Although this phase of the trial was not powered to demonstrate efficacy, we appear to have interrupted the progression of the disease in one subgroup of patients. We are anxious to move to future trial phases to examine therapeutic efficacy.”

Indeed, a Phase II trial with much larger cell dosage has been approved. From the company:

The Phase II trial is designed to treat up to 15 ambulatory ALS patients, in five different dosing cohorts, advancing up to a maximum of 40 direct injections and 400,000 cells per injection, based on safety. This compares to a maximum of 15 injections of 100,000 cells each, directly into the gray matter of the spinal cord, in the completed Phase I trial. The first 12 Phase II patients will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function; the final three patients will receive both cervical and lumbar injections.


And yes, as we reported in January a clinical trial is being prepped for chronic spinal cord injury – for those one to two years post. It is expected to begin enrolling patients this summer as centers and institutional approvals are lined up. The company hasn’t released any information about the trial but a look at the trial detail at clinicaltrial.gov shows that several centers have been identified:

• Crawford Research Institute at the Shepard Center in Atlanta. Former Reeve Foundation International Research Consortium on Spinal Cord Injury Associate Keith Tansey, M.D., Ph.D. is listed as principal investigator for the study. (keith_tansey@shepard.org).
• University of Miami
• Thomas Jefferson University Hospital, Philadelphia
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• Karl Johe, the chairman and chief medical officer of Neuralstem, announced this week that UCSD Medical School would also be one of the trial centers. For more about this site, contact Adrienne Rebollo, arebollo@ucsd.edu.


I spoke with Johe: “The dogma has been that human cell transplants to the spinal cord were not feasible. First, the environment is too hostile, due to necrosis and inflammation. Second, there is no way to overcome this. We have shown here [in the acute rats], however, that our human cells integrate into the animals. Most of the stem cells die. Some survive and they proliferate in the injured area; they continue to divide until they fill the cavity. At that point they begin to differentiate into neural tissue.”

According to Marsala, the 556 cells appear to be doing two things: stimulating host neuron regeneration and partially replacing the function of lost neurons. “Grafted spinal stem cells are a rich source of different growth factors which can have a neuroprotective effect and can promote sprouting of nerve fibers of the host neurons. We have also demonstrated that grafted neurons can develop contacts with the host neurons and, to some extent, restore the connectivity between centers, above and below the injury, which are involved in motor and sensory processing.”



Johe said his 566 cells appear to reduce the size of injury. “Our studies with MRI show that the surface area of scar is much, much less. The stem cells also appear to stabilize the injury – the cells restore the integrity of the tissue. The fact the animals showed reduced spasticity is a sign of reduced  secondary damage,” said Johe.

“Rats often recover spontaneously,” said Johe, “so it is difficult to demonstrate a functional benefit; but the animals in our study have more accurate foot placement and better coordination of limb movement.”

Chronic SCI Trial

Johe wasn’t able to predict when this trial would commence – this summer, he hopes. He acknowledged that there has been great interest – the word chronic is extremely rare in SCI trials.

Johe thinks his stem cells are versatile and robust enough to make a difference in both acute and chronic SCI, stroke, even brain cancer. Stem cells, he said, are not like drugs, which might target a specific process or action. “Stem cells are more like a shotgun – they offer many possible actions and mechanisms. A plethora of effects will be required for a reconstructive treatment in the spinal cord.”

Here’s a summary of the chronic trial, from a release

This open-label, multi-site study will enroll up to eight patients with thoracic spinal cord injuries (T2-T12) who have an American Spinal Injury Association AIS-A level of impairment, between one and two years post injury. These patients exhibit no motor or sensory function in the relevant segments at and below the injury, and are considered to be in complete paralysis. Study patients will receive six injections in, or around, the injury site: the first four patients will receive 100,000 cells per injection; the second four patients, 200,000 cells per injection. All NSI-566 SCI patients will receive post-surgery physical therapy, as well as immunosuppressive therapy, which will be for three months, as tolerated. The trial study period will end six months post-surgery for each patient. The primary objective of the study is to determine the safety and toxicity of NSI-566 for the treatment of paralysis and related symptoms due to SCI. The secondary objectives are to evaluate graft survival in the transplant site by MRI, as well as the effectiveness of transient immunosuppression.

It is anticipated that each individual medical center will handle its own recruitment. We’ll pass along more information as it is available.

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Scientists Seek Stem Cell Cure For Spinal Cord Injuries

WAMU

WAMUScientists Seek Stem Cell Cure For Spinal Cord Injuries

By: Emily Berman // January 25, 2013

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or continue to read the condensed transcript here
Thomas Hazel PhD and Richard Garr @Neuralstem
Thomas Hazel, Ph.D, and Richard Garr pose in their neural stem cell laboratory, in Rockville, Md.

Neuralstem, a Rockville-based biotech company, has just been approved by the FDA to begin implanting stem cells into people with spinal cord injuries. While there’s a long scientific journey ahead, this trial could mean hope for paraplegic and quadriplegic patients all over the world.

The nervous system works, by sending electrical signals up and down the spinal cord. Degenerative diseases like Multiple Sclerosis, ALS, or Parkinsons impair the ability to send those signals. “There’s a gap,” says Richard Garr, co-founder and CEO of Neuralstem. He says there’s something that’s blocking signals from getting through.

Unlike our skin cells, the central nervous system doesn’t repair itself when damaged. “You’re born with a certain number of neurons, and that’s the way it is.” says Garr.

In 1998, Garr met Karl Johe, Ph.D. who had made a discovery while working at NIH. Around week 7 or 8, when the human embryo is the size of the tip of your thumb, there are cells in the brain area of the embryo that have all the information they need to become neurons. These are called ‘neural stem cells.’ Dr. Johe developed and patented techniques for extracting and multiplying these cells, then implanting them as ‘replacement neurons.’

“We’re actually putting in cells that are going to turn into neurons that are going to bridge the gap,” he says. “We’re creating new circuitry.”

Dr. Thomas Hazel, the head of Research at Neuralstem, explains one of the most important aspects of neural stem cells is that they can easily replicate. The lab received a donated tissue from a legally aborted fetus about 10 years ago, and they’ve been using those cells ever since.

The surgery recently approved by the FDA is much like an earlier trial, done on ALS patients. The surgeon injects neural stem cells directly into the patient’s spinal cord. Those stem cells grow into neurons, and if all goes according to plan, they help messages pass from the brain to muscles.

The ALS trial is waiting for phase 2 approval, but patients, on their own, are reporting some improvement. The spinal cord trial will take on eight patients who have experienced injury in the past 1 to 2 years in the thoracic spine, which is from the chest, down. Neuralstem will announce the partner hospitals in the coming months, and hope to start the surgeries in summer 2013.

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Bespoke Stem Cells for Brain Disease

excerpt from article: “Over the last 2 years, stem cell therapies have done well in early clinical trials for sporadic neurological diseases, such as ALS and macular blindness. Such therapies have also shown promise for spinal cord injury, and just this week, the US Food and Drug Administration gave approval to the biopharma NeuralStem to begin a Phase I trial with fetal stem cells. It is the second US stem cell trial for spinal cord injury;“

Click Here to read the online article

TheScientist

Bespoke Stem Cells for Brain Disease

Scientists use virus-free gene therapy on patient-derived stem cells to repair spinal muscular atrophy in mice.

By Nsikan Akpan | January 15, 2013

Most children with spinal muscular atrophy (SMA) will never jump rope, play tag, or even walk because a genetic deletion will provoke the gradual destruction of their spinal motor neurons. By correcting this mutation in stem cells derived from patients, Italian scientists have successfully curbed the progression of the disease in a mouse model. The results, published last month (December 15) in Science Translational Medicine, suggest that SMA sufferers may one day serve as their own donors for neuron transplants to treat their disease, according to a report.

“[It] is a beautiful study of the potential for using induced pluripotent stem cells (iPSCs) to treat genetic diseases,” said Lisa Ellerby from Buck Institute for Research on Aging, who was not involved in the study but is currently investigating the use of the technique to treat Huntington’s disease (HD).

Over the last 2 years, stem cell therapies have done well in early clinical trials for sporadic neurological diseases, such as ALS and macular blindness. Such therapies have also shown promise for spinal cord injury, and just this week, the US Food and Drug Administration gave approval to the biopharma NeuralStem to begin a Phase I trial with fetal stem cells. It is the second US stem cell trial for spinal cord injury; Geron abruptly halted the first in 2011.

Adding gene correction to the equation could expand their scope to treat a wide array of inherited disorders, Ellerby said. “As the field demonstrates that patient cells can be genetically corrected, we are closer to using this new technology to either model the disease or develop therapies for human patients.”

SMA is the leading genetic cause of infant mortality, killing one of every 6,000 babies born worldwide. The disease arises when a person fails to inherit a partially deleted version of the survival motor neuron 1 (SMN1) gene, which regulates multiple cellular processes involved with RNA metabolism. There is no cure.
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Somewhere along the evolutionary road to becoming human, the SMN1 gene was duplicated, resulting in SMN2, which can partially compensate for the dearth of SMN1 in SMA patients. Every SMA patient possesses an SMN2 gene. Those with multiple copies of SMN2 experience less severe SMA and typically survive into adulthood. But SMN1 and SMN2 are not identical: a single nucleotide difference impairs the pre-mRNA splicing of SMN2, such that its functional protein is produced at one-tenth the rate of the SMN1 protein.

Neurologist Giacomo Comi of the Univerity of Milan reasoned that if the single differing nucleotide of SMN2 were changed to mimic SMN1 in spinal neurons, perhaps the cells could survive. Rather than correct the SMN2 gene in endogenous SMA neurons, which may be dead or dying by the time the disease is recognized, Comi proposed replacing them entirely with iPSC transplants carrying a corrected copy of SMN2.

“The ideal therapeutic approach for SMA will be a combined strategy of molecular therapy to resolve the genetic defect and cell transplantation that can complementarily address signs of the disease,” said first author Stefania Corti of the University of Milan.

To accomplish this goal, Comi and his colleagues reprogrammed skin cells from SMA patients into iPSCs. The researchers then transfected the iPSCs with sequence-specific oligonucleotides that can repair genes with single base mutations. (In both steps, the researchers avoided using viral vectors because of the risks of tumor formation or harmful immune responses following transplantation.)  Finally, the genetically altered iPSC cells were differentiated into motor neurons and transplanted into mice that displayed symptoms of SMA.

SMA pups that received spinal grafts of “corrected” SMA-iPSC-derived neurons a day after birth showed significantly less spinal neuron loss and muscle atrophy. They were more physically active and stronger, as judged by open-field and grip tests. Neuron transplantation also extended lifespan by 50 percent.

The results suggest that the implanted neurons integrated into the spinal cord to alleviate motor dysfunction. Indeed, fluorescent histology revealed that the transplanted neurons formed neuromuscular junctions with muscle tissue near the spine. The implanted neurons also promoted the survival of the endogenous neurons still carrying the SMA mutation, indicating that the therapy provided neuroprotective benefits to the surrounding tissue as well. When grown in culture, corrected iPSC-derived neurons secreted more growth factors than uncorrected neurons, which may explain this transfer of vitality.

Of course, the research is very early stage, and many years of work will be needed to translate this success to the clinic, but “the implications are significant, not just for SMA disease, but also for similar neurodegenerative conditions like ALS and other neuromuscular diseases,” said Corti. “These data demonstrate the feasibility of generating patient-specific cells that are free of disease.”

S. Corti et al., “Genetic correction of human induced pluripotent stem cells from patients with spinal muscular atrophy,” Science Translational Medicine, 19:165ra162, 2013.

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Neuralstem’s stem cells give spinal injury patients hope

Neuralstem’s stem cells give spinal injury patients hope

FDA gives Rockville biotech green light for initial trial

By Lindsey Robbins

This story was corrected on Jan. 15, 2013. An explanation follows the story.

Richard Garr NeuralStem CEO
Richard Garr NeuralStem CEO

Physicians, researchers, patients and their advocates in the spinal injury field are keeping a close eye on Rockville biotech Neuralstem as it prepares to launch a Phase 1 safety trial of its stem cell treatment for chronic spinal cord injury.

The Food and Drug Administration approved the trial Monday. Neuralstem plans to conduct the study on eight patients who are completely paralyzed at or below their spinal cord injuries.

“It’s important that people understand this is very different from other methods that have gone on before,” CEO Richard Garr said. “This is the real deal. We have compelling data. Cells are surviving, grafting and doing what we would expect they would do.” The FDA go-ahead follows Neuralstem’s report in October that rats given the stem cell product, NSI-566, seven days after suffering an ischemic stroke showed improvement in motor and neurological tests.

“Should this prove to be successful, it will allow for some regeneration of human spinal cord cells and for people to regain function. It will be an incredible breakthrough, with huge implications for the health care market,” said Paul Tobin, president and CEO of the National Spinal Cord Injury Association.

More than 10,000 people in the U.S. sustain spinal cord injuries each year, according to the Christopher & Dana Reeve Foundation. About 840,000 people have chronic spinal cord injury. Currently, the best treatment is mitigating secondary damage and providing environments and tools that support patients with these injuries, Tobin said.

While Tobin emphasized that the industry is still “far from a cure yet,” the Neuralstem treatment could be a tremendous step and appears to be worth exploring.

The primary objective of the study is to determine the safety and toxicity of human spinal stem cell transplants for treating paralysis and related symptoms due to chronic spinal cord injury, according to Neuralstem information. A secondary objective is evaluating graft survival in the transplant site.

All patients will receive six injections in or around the injury site, with the first four patients receiving 100,000 cells per injection and the second four receiving 200,000 cells per injection. The study will follow the patients for six months after the procedures.

Following Monday’s announcement, stock analyst Aegis Capital of New York raised its 12-month price target for Neuralstem to $4 from $3.50.

“Investors should note the fact that spinal cord injury is the clinical indication that most closely mirrors the situation in the preclinical rat model that yielded the ground-breaking data published in the [trade journal] Cell last year,” Aegis wrote in a report Monday.

Keep in mind following things while overnight generic viagra buying a drug or medicine from online pharmacy shop. Some men cialis pill cost are incapable of holding on for more time due to stress and mental depressions. You canadian viagra samples can never trust anyone but yourself in this world. online cialis pharmacy So what options are available for these courses? Why Take Adult Drivers Ed Online Adult drivers education courses online. Neuralstem shares on the New York Stock Exchange, which were trading at $1.18 on Friday, spiked 15.3 percent early Monday to $1.36, before falling to $1.28 later in the day.

Aegis described itself as “cautiously optimistic” about Neuralstem’s treatment, but said the stem cell lines are still in “comparatively” early stages of development and that stem cell research, in general, faces uncertainty. Neuralstem’s stem cells are not from embryos.

Aegis also cautioned that Neuralstem had $9.9 million in cash and equivalents as of Sept. 30, with a monthly cash burn estimated as high as $1.5 million. Garr said Neuralstem is not planning fundraising in the immediate future.

Garr said the Phase 1 trial should begin this spring.

Other stem cell studies

Next month, Neuralstem plans to begin dosing patients with NSI-566 to treat paralysis from stroke in China, with a trial in Korea scheduled for the summer.

Neuralstem already has completed dosing in its Phase 1 trial at Emory University in Atlanta for amyotrophic lateral sclerosis. The trial will end six months after the last surgery. That therapy has received orphan status designation from the FDA, which confers certain advantages, such as a more streamlined process.

Though other companies have looked into this treatment, Neuralstem is the only one with an FDA-approved spinal cord injury trial using stem cells.

Geron Corp. in California had been conducting stem cell spinal cord injury trials in the U.S. but ended up shutting down that portion of its business in November 2011 and later sold it. StemCells is conducting trials in Switzerland.

Neuralstem officials said they hope success with this treatment allows for applications in chronic stroke motor disorder and multiple sclerosis.

“People should take hope,” Garr said.

Karl Johe, Neuralstem’s chairman and chief scientific officer, said the biotech’s data from other studies justify the new trial and the company’s confidence.

“In addition to the pre-clinical animal data, we have conducted 18 successful surgeries using the same cells and surgical device in our ALS trial,” Johe said in a statement. “That trial has demonstrated that the surgical route of administration and the cells are safe and well-tolerated and that the cells survive long-term in the patients. The successes of our human clinical experience, combined with the compelling data from the preclinical spinal cord injury animal studies gives us confidence that we are prepared to move into this additional indication for NSI-566.”

lrobbins@gazette.net

Explanation: The original version omitted a word from this quote by Richard Garr: “Cells are surviving, grafting and doing what we would expect they would do.”

Posted on

Paralyzed Rats Walk Again After Stem Cell Transplant

Technology Review Published by MIT

http://www.technologyreview.com/view/429222/paralyzed-rats-walk-again-after-stem-cell/

The rodent recovery spurs hope that humans could one day benefit from similar treatments.

Susan Young  <http://www.technologyreview.com/contributor/susan-young/>

Thursday, September 13, 2012

Rats once paralyzed from complete surgical cuts through their spinal cords can walk again after stem cells were transplanted into the site of the injury, report <http://www.sciencedirect.com/science/article/pii/S0092867412010185> researchers today in the journal Cell. The results suggest that stem cells might work as a treatment for patients even if they have completely severed cords, a potential therapy that has been viewed skeptically by many in the
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Neural stem cells, derived from aborted fetal spinal cord tissue, were
implanted onto each side of the spinal cord injury in the rats along with a supportive matrix and molecular growth factors. The human stem cells grew into the site of injury and extended delicate cellular projections called axons into the rats spinal cord, despite the known growth-inhibiting environment of the injured spinal cord. The rats’ own neurons sent axons into the transplanted material and the rats were able to move all joints of their hind legs.

The cells are produced by a Rockville, Maryland company called Neuralstem <http://www.neuralstem.com/> . The same cells are also being tested in ALS patients (see “New Cells for ALS Patients
<http://www.technologyreview.com/news/428956/new-cells-for-als-patients/> “) where they have shown some promise of stabilizing the progressive disease. Last month, the company announced
<http://investor.neuralstem.com/phoenix.zhtml?c=203908&p=irol-newsArticle&ID=1463178&highlight> that it has asked to FDA to approve a trial to test the cells in spinal cord-injured patients.

Researchers are currently testing neural stem cells from a Newark,
California-based company called StemCells Inc. <http://www.stemcellsinc.com/> , in spinal cord injured patients; two of the three patients have reported the recover of some sensation (see “Human Stem Cells Found to Restore Memory <http://www.technologyreview.com/news/428532/human-stem-cells-found-to-restore-memory/> ” for an overview of the company).

Posted on

Stem Cells Help Rats Recover Lower-Body Movement

Genetic Engineering & Biotechnology News |
www.genengnews.com

GENNewsHighlights <http://www.genengnews.com/gen-news-highlights/>

Sep 13, 2012

Stem Cells Help Rats Recover Lower-Body Movement

http://www.genengnews.com/gen-news-highlights/stem-cells-help-rats-recover-l
ower-body-movement/81247315/

A half-dozen paraplegic rats recovered movement in all lower joints after being transplanted with <http://www.genengnews.com/keyword/neuralstem/3100> Neuralstem’s <http://www.genengnews.com/keyword/nsi-566/8579>  NSI-566
spinal cord <http://www.genengnews.com/keyword/stem-cells/304>  stem cells-a result the company said could aid in treating human <http://www.genengnews.com/keyword/spinal-cord-injury/692>  spinal cord injury.

The six were among 12 rats experiencing lower-body paralysis after
undergoing complete spinal transections. The six were assessed over seven
weeks and compared to a control group that had not received transplants.
Neuralstem published results of its spinal cord stem cell transplant in the
journal Cell, in a paper titled “Long-Distance Growth and Connectivity of
Neural Stem Cells After Severe Spinal Cord Injury: Cell-Intrinsic Mechanisms
Overcome Spinal Inhibition.”

According to the study, rats treated with NSI-566 showed significant
locomotor recovery, with most (57%) of the grafted cells turned into
neurons. Also significant, according to the company, was the number of axons
that emerged, extending over 17 spinal segments both above and below the
point of spinal cord lesion. The axons expressed synaptic proteins in the
host gray matter, suggesting they made synaptic contact with host spinal
neurons.

“The fact that these cells induce regeneration of axons and partial recovery
of motor function makes them relevant for testing for the treatment of human
spinal cord injury,” Karl Johe, Ph.D., Neuralstem’s chairman and CSO, said
in a statement.

According to the paper, retransecting the spinal cord immediately above the
graft abolished functional gain, a finding that Neuralstem said indicated
that the regeneration of host axons into the human stem cell graft was
responsible for the functional recovery.

Neuralstem has submitted an application to the FDA for a trial to treat
chronic spinal cord injury with NSI-566. The cells were used in a recently
completed Phase I clinical trial for amyotrophic lateral sclerosis (ALS or
Lou Gehrig’s disease).

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Neuralstem Gains on Stem Cell Therapy for Paralyzed Rats

By Ryan Flinn on September 13, 2012

http://www.businessweek.com/news/2012-09-13/neuralstem-gains-on-stem-cell-therapy-for-paralyzed-rats

Neuralstem rose (CUR) 40 percent to $1.40 at 12:43 p.m. in New York, after earlier increasing as much as 51 percent in its largest intraday gain since Sept. 21, 2009. The Rockville, Maryland-based company’s shares had risen 3.6 percent this year through yesterday.

Prior to captivating this medicine, regard as to cautiously appraise all the feasible dangers and advantages connected with it. discount cialis is the best and most proficient generic key for combating erectile dysfunction. It is a simple, effective way to resolve those tense situations where one child is trying to control or hurt or trespass on another and it is highly, highly effective. http://www.energyhealingforeveryone.com/gcp/GCS.pdf buy cheap cialis “Just walk away.” When a bully tries to steal your child’s emotional well-being, realize that that bully really does not have access to it, your child does. Chiropractic thought is reliant when the relative between the body nervous system and the skeletal online prescription viagra or bone structure. These kinds of cures are the best choices to go with as it comes in three types of consumption like jelly, tablet, and soft tablet and remain demanding medicine by ED men. viagra sales in uk Researchers severed the spinal vertebrae of 12 rats, then gave half of them Neuralstem’s stem cells a week after the injury, according to the study published today in the journal Cell. The rats that received the injections gained “significant locomotor recovery,” according to a company statement.

Neuralstem also is testing its therapy in early human clinical trials for
amyotrophic lateral sclerosis, known as Lou Gehrig’s disease, and for
depression.