Reeve Foundation Paralysis Community

I think my daughter's hopes of ever being able to try a clinical trial has been hopelessly lost in the red tape of the FDA approval system.  I have been informed by others of disability, the FDA criteria for adult stem cell is to classify the cells as a drug, meaning the cells from my daughter's body will have to go through 7 to 12 yrs. of approval before ever being allowed to be used in a clinical trial.  I have called and emailed my representatives and I feel the reason why Texas is so for adult stem cell, is because they don't have to deal with it for another 7 to 12 yrs.   We all need to call and email our elected officials and let them know this shouldn't be happening.  For the past 30 yrs. stem cell have been used in transfusions and bone marrow procedures.  What's the difference between that and adult stem cell?  To find out more information on this subject at the FDA's website www.fda.gov/cber/gdlns/pbsc.htm.  Please call your representatives of your state and let them know that the classification of adult stem cells needs to be changed.

Mom and caregiver/attendant for our daughter, 23 yrs. old, c5 c6 incomplete, injured in a diving accident while away at college in 2007

---

Joyce
Texas

Your post is a story that is all too often heard. I am working diligently with ASCTA to help fight the FDA's declaration that our own stem cells are drugs. We need a huge outpouring of help from the public for this grassroots effort to bring about effective change. As co-founder of the Stem Cell Pioneers forum,  I hear from many people too ill to travel outside the U.S. for treatment. The FDA is literally signing their death sentence with its declaration. It will make treatment unreachable for so many in their lifetime. With close to 10,000 articles published on mesenchymal cells alone and tens of thousands of people who have had adult stem cell treatment, the only possible answer for the FDA doing this is big pharma in my opinion. Fertility clinics are under no such regulations as they want to impose on doctors giving autologous (a person's own stem cells) treatment and yet fertilitiy clinics manipulate cells every day. ASCTA advocates safe stem cell treatment and has already written physician and lab guidelines. Please join and write the FDA and your legislators. Barbara Hanson

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

ASCTA needs your help and voice

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 

 

We need your help raising awareness of our Safe Stem Cells Now! cause.  Our press release from last Thursday is just starting to pick up steam on the web and here's how you can help:

 
1.  Go to this article link about the ASCTA opposition to FDA and click the "Digg" button on the left.  This will draw attention to the news. http://tinyurl.com/cvyulq

2. If you have a Twitter account, post these tweets to your account (simply copy and paste - be sure to include the link)

 

• The FDA is claiming a person's own stem cells are drugs and should be regulated. http://tinyurl.com/cyyv57
• Join the ASCTA (American Stem Cell Therapy Assoc) at www.safestemcells.orgto fight FDA claim that they should regulate adult stem cells.
• Facebook conversation heating up over FDA's position that a person's adult stem cells are drugs http://tinyurl.com/chvh66

3. If you have a Facebook account:

• Copy the individual sentences above and post them in your Facebook status
• Click this link to join the Facebook conversation happening right now about this topic and post your comments. http://tinyurl.com/chvh66

4.  If you have any other social network account such as MySpace, FriendFeed, Ning, Bebo, imeem, please post the short sentences above (including the links) to your accounts.

 

5.  If you have a blog, please take a moment to post your opposition to the FDA's position.  Use your own words. Or if you would like some help to make it easier, consider the following paragraph.

 

"The FDA has taken the position that a person's own stem cells are drugs and therefore should be regulated (see news article here http://tinyurl.com/cyyv57) . I believe that stem cells are not drugs - they are a natural part of human tissue and we have every right to use them for the medical treatment of our conditions or diseases.  FDA regulation would only delay or even prohibit access to safe stem cell therapy and would force people to look outside the U.S. for treatments.  Many people who are sick with conditions or diseases that could benefit from stem cell therapy right now don't have 5-7 years to wait for clinic trials. A patient movement has been formed by the American Stem Cell Therapy Association (ASCTA), www.safestemcells.org, to bring awareness to the issue.  The patient movement is called Safe Stem Cells NOW! and more information can be found at www.safestemcells.org.  Please consider joining these organizations to help get the word out or link to this blog post."  

 

Every bit of online awareness is appreciated. Thanks for your help!

 

 

I agree and hear your frustrations.  We have the world's most expensive drug approval process that hasn't bought us safer drugs.  Classifying the cells in your daughter's body as drugs is not about safety. 

We have formed ASCTA to balance adult stem cell availability with safety.  Your daughters adult stem cells are not drugs.  As Barbara has said in her post above, the best place to focus your energy is to help change the status quo.  See www.safestemcells.org. 

Chris Centeno, M.D.

  I do NOT want the FDA delcaring my own stem cells as drugs!!!   When a person has their own blood drawn for their use in an upcoming surgery, is it a drug?  If I donate a kidney, is it then classified as a drug? 

  Barbara, I agree with your statement about the fertility clinics.  It seems that the FDA has double standards.  The FDA seems to "partner" with the pharmaceutical companies.  After all,  the pharmaceutical companies wouldn't be very happy with knowing that people could actually use their own stem cells to improve their health or even cure their disease.  And that is why I too, have joined the ASCTA in their efforts for SAFE STEM CELLS NOW!