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What's in store for stem cell treatments?
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At yesterday's hearing on stem cells, the FDA set a high bar for the treatments, saying that any therapies would have to have very compelling data in order to move into human trials. The FDA's wariness is due to uncertainty about stem cells effects on the body. While the treatments show promise, researchers do not yet have all the answers regarding the long-term effects of such treatments. Tumors, in particular, are a concern. Geron, Novocell, Neuralstem and Advanced Cell Technology are nearing human trials--uncharted territory for stem cell therapies.
The FDA took a key step as it began drafting a blueprint for how the stem cell therapy trials would be conducted. "We've talked about how long we need to monitor people for, and the answer is forever," said Gordon Weir, a panelist on the advisory committee. "We're putting in these cells, and we don't know what they're going to cause in terms of trouble." Drug developers are looking to the FDA to elucidate the regulatory hurdles they'll face as stem cell therapies move through clinical trials. Without clear guidelines, drugmakers will face an unclear development process complicated by uncertainty and controversy.
- check out the CNNMoney article
- read this Wall Street Journal report for more
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Comments
By Anonymous | Posted 10:57am | July 7, 2008
subj: FDA oversight of stem cell R&D
Here we can see the evil FDA hard at work on plans to choke off any meaningful progress in stem cell therapy. There are a number of proven adult stem-cell therapies, such as those which have been demonstrated to be safe and effective in treatment of heart damage resulting from MI which should be made available to such patients immediately! Instead, these treatments are being stonewalled through interminable "studies" with largely meaningless endpoints, all of this, of course, in service to the FDA's principal charge of being a vicious political lapdog in obedience to it's socialist masters.
By urs.lienert@lienert-combasis.ch | Posted 3:46am | October 23, 2008
The FDA and stem cells therapies.
Cheers
DXX
By Dr. Nick Poulios | Posted 1:21pm | September 4, 2009
There are clinics outside the US, such as EmCell in Ukraine, that offers advanced patented methods of embryonic stem cell treatment for different diseases and conditions. The embryo-fetal stem cells they use are nonspecialized cells able to differentiate (turn) into any other cell types forming different tissues and organs. Embryonic/fetal stem cells have huge potential for differentiation and proliferation and are not rejected by the recipient’s body.
Embryonic stem cell therapy has proven to be effective for organs and tissues restoration, and for fight against the incurable and obstinate diseases. EmCell treats patients with various diseases, such as diabetes mellitus, multiple sclerosis, Parkinson’s disease, Duchenne muscular dystrophy, cancer, blood diseases and many others, including rare genetic and hereditary diseases. Among their patients there are also people willing to undergo anti-aging treatment. Stem cell treatment allows for achieving effects that are far beyond the capacity of any other modern method.
For over 16 years, EmCell has performed more than 5,000 transplantations of embryonic stem cells to people from many countries, such as the USA, Italy, Germany, China, Poland, Russian Federation, Greece and Cyprus, etc. These stem cell treatments helped to prolong life and improve life quality to thousands of patients including those suffering from the incurable diseases who lost any hope for recovery.
If you found this helpful, there is more info:
http://stemcells-4life.blogspot.com/
