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FDA OKs First Human Trial of Neural Stem Cell Therapy

Posted by kdawson on from the spine-enhancing dept.

An anonymous reader sends word that the FDA has approved a phase 1 trial for Neuralstem, a company with a patented stem cell procedure targeting ALS (Lou Gehrig's disease) and other spinal conditions. The company's CEO said in a press release, "While this trial aims to primarily establish safety and feasibility data in treating ALS patients, we also hope to be able to measure a slowing down of the ALS degenerative process." Results are expected in 2 years. The trial will involve 12 ALS patients who will receive stem cell injections in the lumbar area of the spinal cord. An information site for the disabled community adds hopefully: "If it makes it through all stages of testing, we will see if doctors are willing to [use] it on subjects that have injuries coming from physical injuries like diving accidents."

5 of 149 comments (clear)

  1. Dr. Stephen Hawking by Anonymous Coward · · Score: 3, Insightful

    Any chance that this could be passed through quick enough to prolong a certain genius' life?

  2. Big News? by lobiusmoop · · Score: 3, Insightful

    It makes me sad that this is news in 2009. This should really have been commonplace research by now.

    --
    "I bless every day that I continue to live, for every day is pure profit."
    1. Re:Big News? by PopeRatzo · · Score: 3, Insightful

      You think it's the FDA that's been holding up stem cell research, and not the religious yahoos?

      --
      You are welcome on my lawn.
    2. Re:Big News? by Bruce+Perens · · Score: 3, Insightful

      Well see, we have this massive bureaucracy in the USA called the "Food and Drug Administration

      Were you aware that there are other countries? :-)

      All of the folks arguing about health care don't make the connection that Hawking has lived so long in a country with socialized medicine.

      --
      Bruce Perens.
  3. Existing Conditions? by BJ_Covert_Action · · Score: 3, Insightful

    The article states that the clinical trials are being conducted on patients with various levels of the disease. It also states that they are hoping to see the degenerative rate of the disease slow due to the treatments. It does not, however, talk about whether or not this stem cell treatment, or a similar one, could be used to treat patients with a developed case of ALS. For instance, to the /.er that talked about saving Hawking's life, Hawking has had the disease long enough that many of his motor neurons have probably already died out. Can this treatment be used to restore or replace said neurons? For those ALS patients that are already severely disabled, treatment needs to go beyond the stage of slowing the disease down. I would love to see ALS patients walking and talking again that couldn't previously.

    Neuralstem's own website also seems rather scant in details on therapy for highly developed levels of ALS. Does anyone know of any research being conducted to treat the latter stages of ALS or how relevant this treatment is for those stages?

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