SN,
You should PM or email Marti in Benicia. She is actively pursuing something similar with the FDA.
Good luck.![]()
This is a discussion on Contact the FDA about Mesoblast Stem Cells within the Emerging Spine Surgery Technologies forums, part of the Spine Surgery Support category; I contacted the FDA by phone and was told the email address to begin contact with them about this technology ...
I contacted the FDA by phone and was told the email address to begin contact with them about this technology is OCOD@CBER.FDA.GOV. I have therefore just emailed them my opinion and request for them to give this technology the "expedited" label. I will also send a physical letter too. If you look at the FDA website (,http://http://www.fda.gov/MedicalDev...cm089643.htm#4) you can see they have a process of faster approval for technologies that will help those urgently in need. I stated my case that this technology is by far superior and provides a cost benefit in treatment of degenerative disc disease. I believe this technology is the future and will benefit everybody. I strongly encourage others to also make contact with the FDA to encourage them to take a keen interest in approving this technology. I believe we need to make our voices heard. I hope many of you will join me, and I hope to get the word out through other means. Some of you may laugh at my request and think I am waisting my time, but I know this is not the case. I believe if a cause gets enough voices behind it, the cause will gain attention. I also plan on attempting to get others in my family and my friends to write the FDA in support of this technology. They may laugh at me, but I do not care and I will continue my efforts. I have no interest in mesoblast financially or any other area besides the belief this technology is revolutionary in the treatment of DDD. Please respond with your opinions about this effort, and if you do write or call the FDA I would like to hear about your efforts. Thank you for your time.
Riding 4 wheeler and playing basketball. Collide with guy in mid air and I hit concrete on one leg and then fall down. Wake up in pain cant move for few hours, fine few days later. Back never the same.
dec 2007 horseplaying with father, contained l5-s1 disc herniation with sciata on right leg, traction helps and time, pain free, diagnosed ddd l4/l5 and l5/s1
SN,
You should PM or email Marti in Benicia. She is actively pursuing something similar with the FDA.
Good luck.![]()
Justin Averna
Founder & President, Spine Patient Society™
www.SpinePatientSociety.org
A 501(c)(3) Tax-Exempt Nonprofit & Charitable Organization
I'm here to help.
- 1994: Football Injury, Severe Hyperextension
- 1997: Snow Skiing Injury
- 3/7/1997, 17 years old: Laminotomy L4/L5
- 1999 & 2003: Motor Vehicle Accidents (not at fault both times) --> Grade V Annular Tears L4/L5 & L5/L6
- 11/15/2003, 23 years old: 2-Level ProDisc® L4/L5 & L5/L6*, *lumbosacral transitional vertebra --> Dr. Rudolf Bertagnoli
- 4/2008: 4.5 years pain-free before "new" leg pain
- 5/14/2009, 29 years old: Dynamic Stabilization System L4/L5, Dr. Rudolf Bertagnoli
Questions? Suggestions? Need help with registering, creating a signature, etc.?
justin (at) spinepatientsociety.org
Disclosure: I have no financial relationships with any surgeons, spine clinics, device manufacturers, pharmaceutical companies, hospitals, etc. -- the SPS Board of Directors serve without compensation.
Has anybody else done this? I am still waiting for an email back from the FDA. I hope alot of people will do this. I really think if alot of people email them and contact them it will make a difference. I dont want to wait on the sideline!!! I am sure that is how alot of people feel about new technologies which can help them though lol.
Riding 4 wheeler and playing basketball. Collide with guy in mid air and I hit concrete on one leg and then fall down. Wake up in pain cant move for few hours, fine few days later. Back never the same.
dec 2007 horseplaying with father, contained l5-s1 disc herniation with sciata on right leg, traction helps and time, pain free, diagnosed ddd l4/l5 and l5/s1
Has anybody heard form marti in benecia? I emailed the person and never did get a response. So, Marti if you see this message me on here.
Riding 4 wheeler and playing basketball. Collide with guy in mid air and I hit concrete on one leg and then fall down. Wake up in pain cant move for few hours, fine few days later. Back never the same.
dec 2007 horseplaying with father, contained l5-s1 disc herniation with sciata on right leg, traction helps and time, pain free, diagnosed ddd l4/l5 and l5/s1
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