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FDA green lights stem-cell clinical trial for Lou Gehrig’s disease

NATURE PUBLICATIONS

FDA green lights stem-cell clinical trial for Lou Gehrig’s disease 

September 22, 2009

http://blogs.nature.com/news/thegreatbeyond/2009/09/fda_green_lights_stemcell_clin.html

Monya Baker

The Maryland company NeuralStem has the U.S. Food and Drug Administration’s permission to test its spinal cord stem cells in twelve patients with amyotrophic lateral sclerosis. The approval comes a month after the FDA placed Geron’s planned clinical trial on hold for a second time. NeuralStem’s trial had also previously been placed on hold by the FDA in February before receiving the go-ahead in September.

Though both trials involve placing cells into the spinal cord, NeuralStem’s product is made of cultured neural stem cells derived from a single 8-week fetus; Geron’s product, intended to treat spinal cord injury, is derived from embryonic stem cells that have been differentiated into precursors of neuron-support cells.

This anti-impotence pill is formulated with viagra samples no prescription including sildenafil citrate that is the proven parent chemical that works best in treating male impotence, Preparations like Asparagus racemosus, Curculigo orchioides, Dactylorhiza hatagirea, curculigo orchioides, and Chlorophytum borivilianum are frequently prescribed by doctors to act as stimulants and increase the flow of blood to the sexual organs of the body. For example, the free expression that canadian viagra pills comes with sex like gasping, laughing, singing, sighing and sometimes coughing may be avoided or suppressed. You can free viagra prescription try content personally enroll as many as 1-in-3 suffering at least occasional episodes of premature ejaculation. Durex Real Feel: Given an option, men would any day prefer cheap sildenafil no prescription having sex without a condom than with one because the latex material of condoms reduces the overall pleasure of sex. “This is certainly the first stem-cell approach for ALS,” says Lucie Bruijn, a scientist at the ALS Association, a patient group that also funds relevant research. Most other approaches for treating ALS are small molecule drugs, she says, and she’s not aware of other cell therapy or other invasive approaches entering human testing in the near future.

ALS has not funded NeuralStem’s work directly, Briujn says, but has advised the company and funded academic scientists who’ve been involved with the company.

NeuralStem’s chief scientific officer Karl Johe says tests of large animal models show that the transplanted cells exert a neuroprotective effect over motor neurons, but it’s not entirely clear how. Earlier this year, Neuralstem and collaborators published results in a rat model of ALS showing that transplanted cells could develop into interneurons that formed synapses with the rats’ motor neurons.

However, Johe emphasized that the upcoming trial will assess safety rather than efficacy. The first few patients selected for the procedure will be those who are no longer able to walk. Because the injected cells protect rather than replace motor neurons, these sicker patients are less likely to benefit from treatment, but they are less able to lose function if something goes wrong. Cells will be injected only on one side of the spinal cord in order to minimize the number of injections into the spinal cord. Only one patient will be injected each month, so that researchers can monitor for effects over a longer period. Eventually, Johe says, the goal is to be able to inject cells in both lower and upper regions of the spinal cord in healthier patients, and see if the injections can keep motor neurons healthy.

The trial is expected to take place at Emory University in Atlanta, Georgia. Though the FDA is allowing the trial to go forward, the university’s patient-safety board will also need to approve the trial before it can proceed. Johe declined to say when that would be but said discussions were well underway.

Other companies using neural cells include ReNeuron, which received permission from UK authorities this January to start clinical trials for stroke. Its cell product is made from genetically modified cultures of neural stem cells, also of fetal origin.

StemCells Inc is conducting trials in Batten’s disease, a neurodegenerative disease that strikes children, and recently received approval for a clinical trial for a similar disease. It also uses neural stem cells from material originally derived from fetuses and has recently published results showing that its cell product delayed some symptoms of the disease by about three weeks.

As with human embryonic stem cells, the patent situation for neural stem cells is contentious. In a pair of dueling press releases this May, NeuralStem and Stem Cells Inc both claimed key intellectual property on these cells.

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FDA Hearings on Stem-Cell Drugs

FDA Hearings on Stem-Cell Drugs
By ALICIA MUNDY
April 10, 2008; Page D3

The contentious debate over embryonic-stem-cell research is entering a new chapter as biotech companies press the Food and Drug Administration to approve clinical trials for the first generation of stem-cell-derived drugs.

The FDA has set two days of hearings starting Thursday to discuss how the agency may regulate embryonic stem-cell therapies. FDA officials say they expect the hearing will draw a crowd of biotech executives, investors and researchers, and representatives of patient-advocacy groups.

The biotech industry and investors want more certainty about the FDA’s guidelines for the complex approval process ahead, and assurance that the FDA isn’t averse to approving embryonic-stem-cell therapies for political reasons.

One company involved in the hearings, Geron Corp., of Menlo Park, Calif., is set to file what it says is the world’s first embryonic-stem-cell proposal with the FDA. If approved, the company could begin human testing of a therapy to repair acute spinal injury. The company expects to submit its proposal this summer.

During a conference call with investors this year, executives touted the upcoming FDA panel. “We are actually playing a very central role,” said Chief Executive Tom Okarma, adding that the FDA had invited Geron to give “a major presentation.”

A lot of it has to do with dig this buy canada levitra what they think about the treatment that they’re getting. It works to restore sexual desire by freeing up testosterone, thereby allowing you to have better sex drive and stamina sales online viagra levels. Because of to their compact measurement, it does not necessitate a wonderful deal of salt to respitecaresa.org online cialis have detrimental affects. 6. The cost of the medicine commander cialis is about $ 1.00 per pill. “The FDA is nervous. It’s under tremendous pressure. They can’t appear adversarial but they can’t seem to be rolling over for industry, either” said Richard Garr, CEO of Neuralstem Inc., which develops adult-stem-cell products. Mr. Garr said he is worried that if the hearings focus on unresolved safety problems in embryonic-stem-cell technology the FDA could decide to slow down the process of considering stem-cell therapies. “It’s my nightmare scenario,” he said.

The hearings could provide a stage for some companies to make a splash about new cell-based drugs in development or to prod the FDA on shifts in the way it judges safety standards for embryonic-stem-cell therapies. The FDA is reviewing other stem-cell-based technologies, but embryonic stem cells are prized because they can regenerate quickly and act like almost any other cell in the body.

“There is now enough of a critical mass to have this meeting,” said FDA spokeswoman Karen Riley.

Concerns remain that embryonic stem cells can trigger benign tumors called teratomas.

“There’s always an issue for the FDA with novel technologies” on how to evaluate safety, said Celia Witten, director of the agency’s office of cellular, tissue and gene therapy.

One of the most-critical problems the FDA must tackle is how to determine the length of time for a stem-cell trial in animals before proceeding to human testing, Dr. Witten said.

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Stem cells delay paralyzing disease

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

By Maggie Fox, Health and Science Editor

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

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

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

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

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

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

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

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

 

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

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

NO CURE

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

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

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

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

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

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

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

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