Thursday, September 6, 2012

The Promise of Regenerative Medicine

Kenneth A. Pettine, MD
Co-founder of The Spine Institute and founder of the Orthopedic Stem Cell Institute

Dr. Kenneth Pettine of the Orthopedic Stem Cell Institute provides a preliminary but promising report on allogeneic mesenchymal precursor cells.


Administering undifferentiated stem cells to an injured disc has made adult stem cell regenerative medicine in spine a reality. Adult stem cell regenerative medicine holds the promise of stabilizing or even reversing the degenerative changes associated with aging or following traumatic injury. Current clinical use of stem cells is very limited, in part by the cumbersome approval process. The use of concentrated bone marrow aspirate (BMC) as a “stem cell” preparation is currently the simplest and safest way of utilizing the regenerative potential for mesenchymal stem cells (MSCs) to promote tissue regeneration. In fact, stem cells concentrated from bone marrow have been shown to stimulate the formation of bone, cartilage, ligament and tendon, and dermal tissues.

Conservative treatment options for lumbar and cervical pain associated with discogenic disc disease (Pfirrmann Grades 3-6) are limited. Treatment options include pain medication, steroids, physical therapy, and chiropractic care. Reversal of disc pathology has not been achieved with current available treatment modalities. Failure of these nonoperative treatments may leave surgical intervention as a treatment option.

The goal of utilizing MSCs is to not only potentially provide pain relief from the painful degenerative disc, but to reverse the degenerative process. There are three methods for placing MSCs into the painful nucleus pulposus.

The use of allogeneic mesenchymal precursor cells (MPCs) is currently being evaluated as a part of an FDA Phase I clinical trial. Extracted from donors and expanded in number by tissue culture, this process isolates and grows the stem cells into pure MPCs which are injected into the nucleus pulposus. This technology does not have FDA approval.

Utilizing expanded, autologous MSCs for injection into the painful disc is the second method. Federal regulations require the approval of an Investigational New Drug application supported by prospective, randomized clinical trials for the use of expanded autologous MSCs. The FDA has not approved this technology.

The third method involves autologous point of care therapy. This technology does not require FDA approval. The patient’s own MSCs are directly injected into the nucleus pulposus of the symptomatic degenerated disc(s) using standardized two needle discography technique. This requires fluoroscopic visualization and 2-3cc of MSCs are slowly injected into the symptomatic nucleus pulposus.

I have used Celling Biosciences ART21 technology to perform autologous point of care therapy since October 2011. To date, I've performed 72 autologous MSCs injections in the lumbar and cervical spine.

Research conducted at the Spine Institute includes an IRB approved, prospective, two-arm study to evaluate the treatment of discogenic low back pain with intradiscal injection of autologous bone marrow-derived cells.

Early analysis of the research data reveals the average lumbar pre-treatment Oswestry Disability Index (ODI) was 56.5% and improved to 22.4% at three-month follow-up (P=0.0001). The average lumbar pre-treatment Visual Analogue Scale (VAS) for pain was 7.9 (on a scale of 1-10) and improved to 4.2 at three months (P=0.0005).

There have been no complications associated with the iliac crest aspiration or disc injection. Thus far no patient in the study has undergone spine surgery following treatment. Results obtained with this technique suggest its potential clinical efficacy in the treatment of moderate to severe degenerative disc disease. These results require verification with longer follow-up and randomized prospective studies.

For more information regarding treatment options please visit our websites at SpineRevolution.com or OrthopedicStemCellInstitute.com.

See this article online on the International Society for the Advancement of Spine Surgery website.

9 comments:

  1. Is the Spine Center involved in any of the Phase 2 trials being performed with Mesoblast? Are the MPC clinical trials here at the spine center the same? I'm very interested in learning more as I have been fighting DDD for 8 years and I'm only 27 years old.

    Thanks!

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  2. Awesome information about surgeon,its good thoughts to be share.
    San Antonio Spine Center

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  3. I think physical therapy is best and more effective treatment than others to solve the lumbar and cervical pain. Great information!!Physical therapy

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  4. Needing the Hybrid procedure done. more effective then a double fusion and more cost effective. The FDA approves the fusion separately and approves the artificial disc separately but does not approve having the procedure when put together. What is a person supposed to do if everything else has failed and you cannot afford to go to Europe where the Hybrid procedure is commonly practiced with success?

    ReplyDelete
  5. Needing the Hybrid procedure done. more effective then a double fusion and more cost effective. The FDA approves the fusion separately and approves the artificial disc separately but does not approve having the procedure when put together. What is a person supposed to do if everything else has failed and you cannot afford to go to Europe where the Hybrid procedure is commonly practiced with success?

    ReplyDelete
  6. Needing the Hybrid procedure done. more effective then a double fusion and more cost effective. The FDA approves the fusion separately and approves the artificial disc separately but does not approve having the procedure when put together. What is a person supposed to do if everything else has failed and you cannot afford to go to Europe where the Hybrid procedure is commonly practiced with success?

    ReplyDelete
  7. Needing the Hybrid procedure done. more effective then a double fusion and more cost effective. The FDA approves the fusion separately and approves the artificial disc separately but does not approve having the procedure when put together. What is a person supposed to do if everything else has failed and you cannot afford to go to Europe where the Hybrid procedure is commonly practiced with success?

    ReplyDelete
  8. Regenerative medicine is the panacea for human diseases. MetroMD is a leading institute of regenerative medicine, Los Angeles. The premiere institute treats the patients with HGH therapy, PRP, Stem cell therapy, Botox, Laser skin resurfacing. MetroMD offers the safest treatment and are FDA approved.

    ReplyDelete