Age Management Medicine Enters Stem Cell Therapy Discussion

The adult stem cell debate about the FDA trying to classify the patient’s stem cells as drugs is heating up.  Interesting article this morning from a physician proferssional organization on Regenexx, the FDA, and Adult Stem Cell Clinical and Lab Guidelines.  I think the article says it all.

Age management is a new field that many doctors have embraced.  This AMMG professional group recognizes that physicians should work directly with patients on using their own stem cells as therapies and should produce professional guidelines to allow the safe use of these therapies.

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Adult Stems Cells Improve Heart Function

Two items had major headlines this week:  adult stem cell therapy for cardiac patients and the snow in Vail.  Two recent storms have brought record amounts of snow to Vail.  Words alone can not accurately describe the back bowls!

Back Bowls in Vail

Physicians at  Emory University  have demonstrated that infusing bone-marrow-derived, autolgous stem cells in patients who have sustained a heart attack and underwent angioplasty, had an increase in blood flow to the heart.  The study examined the significance of injecting three different amounts of stem cells:  5, 10 and 15 million cells.  At three months, the patients who received higher doses of stem cells showed the greatest improvement in blood flow to the heart.  This is very promising technology and has the potential of re-defining the management of patients with heart disease.

Minimal Culture Expansion: A Historial Perspective

The evolution of In-Vitro Fertilization (IVF) illustrates the development of a minimal culture expansion process.  In the late 1970’s, the first IVF was performed.  In the 1990’s, in an effort to improve conception outcomes, fertility specialists elected to extend the cell culture time.  Specifically they extended cell culture to the blastocyst stage which is a more mature developmental phase. In doing so, the fertility specialists transitioned In-Vitro Feritlization from a simple tissue transplant to a cell culture technique.  These specialist maintain that their cell culture techniques are the practice of medicine and not the production of biologic drugs.  No parents who have undergone IVF,  think of their daughters or sons as biologic drugs, do they?

Adult, autologous stem cell therapy was found itself on a similar path.  In an effort to optimize clinical outcomes, some practices expand a patients’ own stem cells thereby increasing the total number of cells available.  Expansion takes 12-14 days and is conducted in a state of the art cell culture lab.  No growth hormone or exogenous products are used to increase the cell count.    If you are a patient who is concerned that this therapy may no longer be available please visit:  www.safestemcells.org

Expansion of Adult Stem Cells: Making A Drug?

Autologous, adult mesenchymal stem cells have proven to be an effective therapy for patients who have orthopedic injuries.  Specifically, autologous, adult mesenchymal stem cell therapy has regenerated cartilage in knees, hips and thumbs, repaired tendon injuries, reduced the size of protrusions in the lumbar spine and healed long bone non-union fractures.

Regenexx isolates a patients own mesenchymal stem cells in a state of the art cell culture laboratory.  Then, in an effort to provide maximal clinical results, it expands the stem cells by a factor of 1,000X.  The process takes 12-14 days and typically yields a mesenchymal stem cell count of 5-10 million cells.  The stem cells are expanded through the use of the patient’s own blood products.  No growth hormone or exogenous stimulates are utilized.  The patented process is unique in its ability to yield such a large number of autologous, mesenchymal stem cells.

In a previous blog, I discussed BMAC:  Bone Marrow Aspirate Concentrate.  The therapy involves taking a patients bone marrow, concentrating it via a centrifuge and re-injecting the concentrate into the area of damaged tissue.  The entire process is conducted in a single setting.  There is no isolation or culture expansion of the stem cells.   BMAC differs significantly from the Regenexx procedure in the type  and absolute number of stem cells injected.  BMAC  yields a high concentration of hemapoetic stem cells which will differentiate into blood products.  The important repair stem cell, mesenchymal stem cells, are in very low concentrations.

Your Own Tissue is Not Yours: It is a Drug

Regenexx utilizes a patients’ own stem cells to repair damaged ligaments, tendons, cartilage and bone.  Regenexx exclusively uses autologous adult mesenchymal  stem cells which are derived from the bone marrow of the patient being treated.  The clinical successes utilizing adult autologous stem cells have been published in peer reviewed journals.  Additional studies have been submitted and accepted and are awaiting publication.  Comprehensive outcome studies have been completed without any evidence of tumor growth.  There have been no complications.  Sounds to good to be true?