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Timing for clinical trials for stem cell therapy in spinal cord injuries is right
Date:10/18/2011

has been subjected to extensive pre-clinical safety testing, may have potential benefits.

Spinal cord injuries not only cause life-long disability and carry major psychological effects, injuries to the cervical spine (neck) have a mortality rate of 10 percent in the first year following injury and an expected lifespan of only 10 15 years post injury.

Some of the evidence for increasing and expanding clinical trials from the study includes:

  • There are more than a dozen recently completed, ongoing or recruiting cell therapy clinical trials for SCI.
  • No experimental mode, rodent or otherwise, will completely mimic the human condition and it is an unrealistic hurdle for all pre-clincial findings to be validated in animals.
  • There are substantial pre-clinical and earlier clinical safety studies of satisfactory quality and reliability carried out so far to justify the immediate translation into the clinic.
  • Advances in the application of regenerative neuroscience to SCI can only be made with an investigative approach that balances excellent preclinical research with rigorous ethical clinical trials.

"At this time, a strong patient advocacy base would likely help provide momentum to help translate current research into clinical applications," said Dr. Fehlings. "Moving forward, all clinical trails must involve peer-reviewed assessment, regulation, independent monitoring, duplication, transparency and accurate record keeping of the every step of the process."

Dr. Fehlings acknowledges that no clinical intervention is 100 percent risk free and uses the examples of other novel therapies such as bone marrow transplantation and the polio vaccine to illustrate how science has forged ahead successfully, despite setbacks along the way.


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Contact: Nadia Daniell-Colarossi
nadia.daniell-colarossi@uhn.ca
416-603-5194
Springer
Source:Eurekalert

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