Mesoblast

[sportsnut3007]

Does anybody know why the fda woulda approve their stem cells for fusion but not disc regeneration. Im sure the fda would have some stupid reason for this lol, but any opinions on why they would refuse to allow their cells to be used for fusion but not disc regeneration?

[Greg]

Does anybody know why the fda woulda approve their stem cells for fusion but not disc regeneration. Im sure the fda would have some stupid reason for this lol, but any opinions on why they would refuse to allow their cells to be used for fusion but not disc regeneration?

Here is a link to a companies website that is using stem cells for disc regeneration.

Back Surgery alternative | The Regenexx? Procedure
Regenexx stem cell treatment procedure | The Regenexx? Procedure

They also have a sectiona about why they dont have to have FDA apporval as it is a "practice of medicine" that is controlled at the state level, not the FDA.

FAQ’s | The Regenexx? Procedure

The doctor I went to for my Fusion, Dr Dimmig, Triangle Orthopedics Durham, NC is doing a clinical trial on fusion with stem cells. I was going to do that surgery because my insurane denied me for fusion. They got approval from my insurance and I still wanted to do it but the procedure had to be PLIF and I wanted ALIF so I decided not to do the trial and go with the good ole surgery (ALIF).

I believe this is the trial that does the stem cells with the fusion.

http://clinicaltrials.gov/ct2/show/N...arolina&rank=2

[dgreen1064]

The FDA is just dragging their feet on this but it WILL get approval. Their bone marrrow transplant product is at IND status and the osteoarthritis phase II trial is under way. They can already sell their stem cell products in Australia so if FDA drags their feet too long, Mesoblast stem cell products will be available in clinics in other countries. Plus Cephalon is investing 2 billon $ in Mesoblast technology. This will gives Meso funds to bring all products through FDA approval. FDA loves big pharma.