n37fefMemberSeptember 15, 2012 at 6:10 amPost count: 1
I hope all is well with you in Vail. I am one of your patients that you performed a discetomy at L5-S1 back in December of 2009. I am doing pretty good and doing my core exercises, cardio and started light lifting. I still have some pain in both legs and feet but it is manageable most the time.
Last month I stumbled across a You Tube video about the Biostat Biologx Fibrin Sealant on CBS Sunday Morning. The video is about an FDA clinical trial NCT01011816 – Biostate System Drug – 11/9/2009. The creator is Dr. Kevin Paulza of the Texas Spine and Joint Clinic in Tyler, TX.
The clinical participants can not have prior surgery for herniated discs.
What is your opinion on this and how far away is it from being approved by the FDA? What other advancements can we look forward to with biologics or regenerative medicine with stem cells for disc issues?Donald Corenman, MD, DCModeratorSeptember 16, 2012 at 9:49 pmPost count: 8455
One of the biggest problems with biologics and the disc is that the disc is avascular (has no blood supply). I have treated patients that have had previous stem cell injections into the disc with no good results. I think the reason for failure is that there has to be a good blood supply to the structure injected with stem cells and the avascular disc will not support new cells that are implanted.
That reasoning continues with this fibrin sealant. I have treated patients who have had platelet gel (PRP or platelet rich plasma) injected into the disc without good results. I understand that the contents of this injection are similar to PRP so I have a difficult time understanding how this is going to be different.
I would love to believe that we now have a new treatment for the disc that can be performed by injection but I have been in the spine field for 35 years. I have seen many “new and improved” treatments come and then go (cage rage, IDETT, PRP, nuceloplasty, chymopapain, dynamic stabilization). All the past new treatments were brought in with much press and fanfare and all left without any notice. The only real new breakthrough in the last 10 years has been BMP (bone morphogenic protein) and that was only for fusion of the spine.
We will have to see if this new injection has any promise. The good news is that it should not be injurious to the disc so there should be minimal downside (except for the injection itself) if it does not work.
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