The FDA is accepting electronic comments regarding human clinical testing of stem cell therapies.
LINK
I beg you to ask the FDA to do everything within their power to expedite stem cell therapies for compassionate use.
Your comments must be posted by close of business on March 26, 2008. Following is my submission and below that is more background on the FDA request for input.
I use some acronyms and abbreviations that are common in the SCI and research community. I put a key at the end of my submission for those of you that are unfamiliar with the terms.
I say this without hyperbole; I am dying. The complications of my spinal cord injury are killing me. I have defied my doctors’ predictions no less than 9 times in the past 3 years. There will be a time in the not so distant future that I do not recover. I have no hope that existing therapies will change this.
I have a child, a beautiful boy, who lost his childhood to my SCI. No child should have that experience. I want to see how his life unfolds. I want to meet the man that he will become. I want to meet my future grandchildren. I want to wring as much life out of this broken body as I can. I am not alone.
Hundreds of thousands of people face terminal hopelessness. Mothers watch their babies struggle in vain for air as SMA-1 steadily suffocates them. People with ALS face the same horrifying fate. Death and despair do not have to win. Stem cell treatments ready for clinical trials may effectively treat these conditions. Should we not have the opportunity to find out?
I acknowledge there are risks. All of life has risks. I have educated myself on the science of stem cells. I have met with key researchers. I believe they have reached a point where it is time to test these treatments in humans. We who know the future our afflictions hold for us are ready to face the risks posed by these treatments. Please give us a chance for life.
Approve clinical trials for hESC. Do not force us to leave our country in search of hope. In foreign clinics we risk fraud, dubious quality of care and worse. We trust in our government to see that, as US citizens, we receive the best possible treatments available in the world. That should include the potential cures made possible by hESC therapies.
Before another dies. Before another is forced to learn the rhythm of communicating while breathing on a respirator. Before another parent faces the despair of their child’s helplessness. Please approve clinical trials with hESC therapies. Thank you.###
SCI = spinal cord injury
SMA-1 = Spinal Muscular Atrophy 1- a condition that manifests in infants around age 3 months and the mortality rate at 12 months of age is 100%.
ALS = Amyotrophic Lateral Sclerosis (Lou Gehrig's Disease) a fatal, progressive muscle-wasting disease.
hESC = Human embryonic stem cells
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FDA Seeks Advice Re: Human Clinical Testing http://www.fda.gov/OHRMS/DOCKETS/98fr/07n-0471-nm00001.pdf
The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will meet April 10 in Gaithersburg, Md., to discuss “scientific considerations for safety testing” of such therapies, according to a notice on the FDA’s Web site yesterday.
"There’s a recognition at the FDA that stem cells are getting closer, and there needs to be some sort of guidelines on how to handle safety,”
Executives at Geron and Advanced Cell said they plan to appear at the meeting. Geron has communicated extensively with FDA reviewers over the design of the first human trial using embryonic stem cells, partly to convince the agency that putting the cells into people won’t result in the growth of abnormal cell clusters called teratomas, Thomas Okarma, Geron’s chief executive officer, said in interviews with Bloomberg.
http://www.telegram.com/article/20071219/NEWS/712190338/1002/BUSINESS
