FDA Approves the First Clinical Trials Using Embryonic Stem Cells

By Nina Bai | January 23, 2009 5:11 pm

spinal cordThe first clinical trial of a therapy based on human embryonic stem cells has received the green light from the FDA, marking a scientific and political milestone for embryonic stem (ES) cell research. The biotech company, Geron Corporation, received approval today for a study that would inject neural stem cells into patients suffering from spinal cord injuries. The study will be mainly a test for safety, but functional improvements, which have been observed in animals trials, may be possible. “For us, it marks the dawn of a new era in medical therapeutics. This approach is one that reaches beyond pills and scalpels to achieve a new level of healing,” Geron Chief Executive Dr. Thomas Okarma said [Reuters].

ES cells are taken from embryos a few days after fertilization and have the potential to differentiate into any type of cell in the body. The undifferentiated cells can’t be used directly, because they can form cancers called teratomas. But they can be used in the lab to generate potentially inexhaustible supplies of all other types of cell[s] that might be needed for repair. The type to be used in the trial are neural stem cells called oligodendrocyte progenitor cells. These support other neurons in the brain and nerves by supplying growth factors and by producing the myelin sheaths that protect neurons from damage [New Scientist]. The FDA will allow Geron to implant these neural stem cells directly into the spinal cords of eight to ten paraplegics. The trials are expected to begin this summer, and may be carried out in multiple medical centers. The patients have not yet been recruited because the injections must take place within two weeks of the spinal cord injury, before scar tissue forms.

Researchers hope that the therapy will induce damaged nerve cells to generate new myelin. In experiments on mice with paralyzed hind legs, the therapy was able to restore some mobility and autopsies revealed regenerated myelin. Researchers will be looking for signs of functional improvement in human patients, but they emphasize that the treatment will not get anyone out of a wheelchair. “Any return of bladder or bowel function, a return of sensation, or a return of lower extremity locomotion would be a very exciting finding,” Okarma said [HealthDay News]. If the human trials prove to be safe, expanded trials involving more severely disabled patients and larger injections may follow. Okarma said the treatment should eventually become cheap and easy to mass produce because the cells can be grown in vats. He believes the cells may be useful for other diseases such as multiple sclerosis, in which nerve cells are stripped of their insulating sheaths, and perhaps strokes [Reuters].

The arrival of the FDA’s landmark decision just days after President Barack Obama‘s inauguration has not gone unnoticed; President Barack Obama has promised to relax the Bush administration’s restrictions on federal financing for such research. But Obama’s ascent to the White House had nothing to do with the U.S. Food and Drug Administration’s granting permission for the new study, Okarma said… In fact, the company says, the project involves stem cells that were eligible for federal funding under Bush, although no federal money was used to develop the experimental treatment or to pay for the human study [AP].

Earlier this week, ReNeuron, another biotech company which had been unable to gain FDA approval, received the go ahead from British regulators to test an ES cell-based therapy on a dozen stroke patients in Scotland. That trial, which would inject neural stem cells into the brains of stroke victims, is also set to begin this summer.

Related Content:
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80beats: Researchers Create Stem Cells Without Cancerous Side Effects
80beats: 5 of 21 Federally Approved Stem Cell Lines are Ethically Tainted

Image: flickr / justin

CATEGORIZED UNDER: Health & Medicine
  • http://clubneko.net nick

    Yes! Re-brand them! ES cells! ES cell research. Not big scary “Dead Baby Stem Cells” moniker we currently use.

    That’s so brilliant. I will spread the word.

  • Bruce Voigt

    Science has been experimenting with cloning and they have not realized that there is a cell orbiting nuclei speed difference between young and old cells. The longevity of Dolly the Sheep is minimal and will find the same of cells produced by ‘T’ cells of maturity. Science, however, has realized that Stem Cells from our babies work better and won’t realize why until they read my paper.

    Bruce Voigt

  • Bruce Voigt

    Hair follicles contain stem cells.

    The same would be found in cuticles of the fingernail – The thing here is that to grow new STUPH, cell division must take place. Fast orbiting nucleus nuclei such as fetus, hair follicle or fingernail cuticle (instigating cell division) would help in cell division of cells in a packed state.

    Because of inflammation again causing cell packing, the success rate of this will be low.

    No matter what is used, AURA of adjoining cells will influence and change (clone) the new substance (as long as it’s same species).

    The big problem is controlling inflammation.
    All that AURA of an amputee that is just going to waste, is now, with the help of New Technology and a open minded surgeon, capable of growing a new limb or whatever and stem cells of any kind are not required!

    Bruce Voigt

  • Bruce Voigt

    A bit about my discovery of CELL DIVISION! …

    The cell has a nucleus with chips (nuclei) of itself in orbit.

    Horizontally to the nuclei orbit, chips are flung out to produce a pole on each side of the orbit.

    The cell and all its chips contain the complete make up of the species.

    The nuclei orbit speed and maturity will determine the strength needed for the poles to pull the cell apart. The nuclei at a pole with all the information of the nucleus of the cell centers to the mass producing a new nucleus with its orbiting chips.

    The cell Earth with one orbit, rock with two some minerals and all life with three and a new species (BRAIN) with four.

    Cells are separated by their aura and will maintain to be in a packed state. In the case of giving three gallons of blood to the Red Cross the blood cells that are left are no longer packed and cell division takes place replacing what was taken (thank goodness)!

    A child that does not have fast orbiting cell nuclei promoting growth will suffer from the disease ?? and will at a young age, age to old age.

    Bruce Voigt

  • http://www.sndtm.com FDA Regulatory Affairs

    Really more informative, The first clinical trial of a therapy based on human embryonic stem cells has received the green light from the FDA. it’s Really milestone for embryonic stem (ES) cell research…..

  • http://MSN welson desouza

    Hi, Doctors,
    I am 61 years old man. I live in Malden-MA. In july/ 1996 I had my heard attack, then one week after I had the second one and tehe two ocasions They did the angioplasty, By 1999 I had the third heart attack
    The Doctors did the catherization + anglioplasty and put a stent in, one month later, I had another heart attack because the stent broke, them they a new angioplaty put a small stent inside the broke one.But something happened that I coudn’t walk, my whole body was so weak and I coudn’t move my legs.
    Then after 6 months the Doctors put in me a peacema- ker, but nothing happened for the better. Then I went to Brasil and I had the bypass, after that I was able to walk again. But since than I feel so weak I feel a lot fatigue, dizziness, musclepain all over my body, include inside my heart, shortbreath and I am not be able to do anything.
    I hope you can do something for me, because I am this way for too long and nobody can help me.
    Thanks so much for your attention

    Welson desouza

  • Brenda Tedders

    Has anyone considered the possibility of a woman who has had any abdominal surgeries, etc. that one of her healthy ovaries could disappear? This could thrust her into a very early menopausal changes and many other LIFE TIME health declines and EXPLOITATIONS. Missing ovaries would not be brought to the victim’s attention. Where will the eggs come from, if they are not using the stored eggs of donors who want to become prenant and thus those extra eggs will be disposed of. According to my information, knowledge and beliefs and a radio broadcast, only eggs which will be disposed of will be used for Embryonic Stem Cell research. WOMEN NEED TO BEWARE of “DO YOU KNOW WHAT HAD BEEN TAKEN OUT OF YOUR BODY WITHOUT YOUR KNOWLEDGE?” (BTT, UP TO 2009)

  • http://www.medicals.multiply.com Taruna Ikrar

    Stem Cell therapy have big potential to benifit for human being.
    Specially to help many people with have chronic disease, untreated.

  • Klarke

    Hey,
    This blog is incorrect Embryonic Stem Cells are still in the pre-clinical research phase and are only able to be used in the UK for IVF research. The stem cells you are refering to are NEURONAL stem cells, which are not derived from embryos. Neuronal stem cells are multipotent, they can only develop into neurons; unlike embryonic stem cells, which are pluripotent and can develop into all tissue types.

  • http://blogs.discovermagazine.com/80beats/ Eliza Strickland

    Hmm — the BBC article published at the time stated that the cells were taken from an aborted human fetus. So I guess that means our phrasing was a little off — the researchers didn’t derive the cell line from embryonic stem cells, but rather from neuronal stem cells taken from the fetus.

  • edgar yaver

    how I participate in a clinical trial for stem cells treatment for hair grow

  • http://www.regulatory-affairs.pl Rob

    Indeed, medicines are getting more and more sophisticated. Genetics and knowlege of pathophysiology of more complex diseases (cancer, neurodegenerative disorders or mental disorders) may lead to completly new therapies. For some diseases simple chemical entities will not be sufficient.

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