Orthopedic Biologic Treatments Questions & Answers
How do Platelet Rich Plasma (PRP), Bone Marrow Aspirate Concentrate (BMAC) stem cells and FlōGraft® (amniotic fluid-derived allograft) accelerate the healing process?
When your body is injured, it initiates a healing response that includes rebuilding tissue. This healing response requires many biologic factors including growth factors and cells. Growth factors are small signaling proteins that help the body initiate and control the healing process. Mesenchymal stem cells (MSC) are specific cells to the musculoskeletal system, which are able to differentiate into different tissue types such as bone, muscle, ligament and tendon. By providing these growth factors or cells to the injured site, physicians may be able to decrease or modulate inflammation, improve or accelerate healing and allow for pain relief or accelerated recovery.
Are Platelet Rich Plasma (PRP), Bone Marrow Aspirate Concentrate (BMAC) stem cells and FlōGraft® all considered regenerative therapies?
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 The additional “pluripotent” stem cells withdrawn from the patient and used for the BMAC procedure are “undifferentiated”, meaning they are able to replicate themselves into (or regenerate) various types of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.
Are amniotic derived products stem cells?
The simple answer is no. Amniotic derived products, such as FlōGraft®, are continuing to gain popularity in the orthopedic field. While many individuals consider an amniotic fluid derived product a stem cell treatment, they are actually more of a healing agent (such as PRP therapy).
FlōGraft®, a cryopreserved, injectable amniotic fluid-derived allograft, is derived from amniotic fluid that is produced during pregnancy to protect the fetus, and harvested during a planned caesarian birth without any harm to the baby or 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 a caesarian 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.
It is important to note the process kills all the cells that were alive, so it should not be considered a stem cell therapy. FlōGraft® is useful in the body’s healing process because the product contains a number of growth factors that aid in tissue healing, much like platelet rich plasma.
How do I know if I am a candidate for PRP, BMAC or FlōGraft®?
There are two ways to determine if you are a candidate for these procedures:
You can provide current X-rays and/or MRIs for a clinical case review ($250).
You can schedule an office consultation that should be covered by your insurance.
Are all Platelet Rich Plasma (PRP) and Bone Marrow Aspirate Concentrate (BMAC) stem cell therapies the same?
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. Nikhil Verma 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.
Is there an age limit for Bone Marrow Aspirate Concentrate (BMAC) regenerative therapy?
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.
Why is Bone Marrow Aspirate Concentrate (BMAC) sometimes called a stem cell “like” therapy?
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. Verma can replicate the same benefits of stem cell therapy without the ethical concerns of using embryonic/fetal stem cells.
Why doesn’t my insurance cover this treatment?
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.
How do I know which one of these procedures is right for me?
Let us review your case to determine if you may be a candidate for orthopedic biologic treatments.