Orthopedic Biologic Treatments Q&A

No. While PRP accelerates the body’s ability to heal itself through the aid of growth factors, it is not considered a regenerative therapy.

BMAC or FlōGraft®, on the other hand, are considered regenerative therapy because they may assist with both healing acceleration and tissue regeneration. The additional “pluripotent” stem cells withdrawn from the patient and used for the BMAC procedure are “undifferentiated”, meaning they are able to replicate themselves into (or regenerate) various types of tissue. BMAC stem cells are “autologous” tissue taken from a patient’s own iliac pelvic bone, while FlōGraft® contains cells and growth factors from donor tissue specifically placenta and amniotic fluid.

FlōGraft®, a cryopreserved, injectable amniotic or placental fluid-derived allograft, is derived from amniotic fluid that is produced during pregnancy to protect the fetus, and harvested during birth without any harm to the baby or mother with the prior consent of the mother. All donors are carefully screened to help protect all patients. This tissue does NOT need to be a “match” for the recipient because the chorionic placental tissue are non-reactive to histocompatibility antigens, thus no graft-vs-host reactions occur.

The amniotic membrane and fluid that surrounds a fetus contains both stem cells and growth factors. During birth, the amniotic membrane and fluid is collected from a healthy donor. The amniotic membrane is processed by freeze drying it and pulverizing it. The powder is then placed in vials and stored at a tissue bank.

FlōGraft® is useful in the body’s healing process because the product contains a number of growth factors and cells that aid in tissue healing.

Clinical studies to document the efficacy of stem cell injections are currently ongoing. As this is an evolving area of orthopedic science, our knowledge regarding the use of stem cells and patient outcomes continues to improve over time.  However, it is important that patients recognize that the treatment is considered experimental and that results cannot be guaranteed.

No. Patients considering PRP and BMAC therapies need to understand that the doctors who administer these treatments buy kits to concentrate and prepare the blood or bone marrow for the injections. There are many companies that sell these kits, but only a small number have received FDA approval for their kits. This means that some physicians are using kits that are not FDA approved or kits that provide significantly less concentrations of cells than the typically more costly approved kits.

Research shows that the minimum level for the concentration of platelets necessary to achieve positive results from PRP injections is 5-7 times that of the blood platelet count.  Studies done in head to head comparisons have repeatedly shown that inexpensive and inferior kits used by some physicians only produce 2-3 times the blood platelet concentrate. It is very important that patients ask if the kits their physicians are using are FDA approved and if they are meeting the concentration levels necessary for a positive outcome.

The PRP kits used by Dr. Brian Waterman are FDA approved and produce at least 7-9 times concentrate of platelets. The BMAC kits are one of only a very few approved by the FDA and consistently produce higher counts of nucleated stem cells than the competitors’ kits in head to head studies.

If you would like to see the leading research on the outcomes of biologic/regenerative treatments, please visit our research library.

Patients up to age 60 can generally achieve tissue regeneration using their own “pluripotent” stem cells through BMAC therapy.

As the body ages, its ability to regenerate tissue from autologous (its own) stem cells diminishes, as the number of stem cells produced by humans decreases with age starting at about age 40. After age 60, autologous BMAC typically fails to provide regeneration because there are not enough stem cells in the bone marrow. Between the ages of 70 and 80, there are almost no stem cells in the bone marrow to use. After age 80, stem cells in the bone marrow are virtually non-existent.

Due to this decline in autologous stem cells, patients over 60 years of age generally achieve better results using a combination of a healing accelerator, like PRP or FlōGraft, and allograft tissues derived from another source for regeneration.

The term “stem cell therapy” is often associated with a controversial treatment using embryonic or fetal stem cells from aborted fetal tissue. By using a patient’s own “pluripotent” stem cells, the innovative therapies used by Dr. Waterman can replicate the same benefits of stem cell therapy without the ethical concerns of using embryonic/fetal stem cells.

Since biologic treatments are still considered experimental, insurance does not cover them and cash payment is required.  To see the leading research on the outcomes of biologic/regenerative treatments, please visit our research library.