Mostly unregulated until recently, regenerative cellular therapy, or regenerative medicine, is surging
The science of regenerative cellular therapy, or regenerative medicine, is catching up with the buzz that surrounds it. It also shows significant potential for pain relief and joint repair.
Regenerative medicine is a catch-all term for the medical specialty that uses tissue engineering and stem cell technologies to repair tissues that have failed to heal on their own. Expectations for regenerative cellular therapy, and the claims made about its efficacy, have at times been ahead of the scientific evidence.
Regenerative medicine has two primary branches. One branch, tissue engineering, focuses on creating replacements for damaged tissue. The other branch is self-healing. This branch uses injections of blood products and stem cells to stimulate the body to heal itself.
Platelet-rich plasma (PRP) is the most commonly performed regenerative medicine procedure. The patient’s blood is drawn and then spun down in a centrifuge. This separates the platelets from other blood components. These platelets are injected into the areas of complaint.
PRP works because the body’s healing response when injured is to mobilize platelets to the site of injury. These platelets contain nutrients and growth factors. In this way, PRP boosts the body’s natural healing response.
PRP therapy does not take much time to perform and typically requires only one injection. The symptomatic relief it provides may last from 3-6 months. Studies have shown that PRP may outlast and outperform corticosteroid or hyaluronic acid injections. However, the science is not clear on the long-term effects of PRP beyond pain relief.
Studies also point out that the results can vary greatly based upon the preparation method, centrifuge used to spin down the platelets, and the delivery method. Most insurance plans do not cover PRP. It is private-pay, and costs can range from $500-2,500.
Autologous conditioned serum
Autologous conditioned serum (ACS) uses a patient’s own blood to promote pain relief. During ACS, the blood is processed to increase growth factors and anti-inflammatory proteins. This blood is then injected into the joints in a series of shots.
ACS blocks interleukin-1 (IL-1), a key component in the inflammatory process. It has been shown to relieve pain and may possibly slow down the damage caused by osteoarthritis.
Studies have shown that ACS treatment is well-tolerated and safe. ACS use, like PRP research, shows that it results in symptom relief. There is no evidence of the regrowth of damaged tissues. ACS is most commonly used for regenerative cellular therapy after damage to tendons, ligaments and muscles.
ACS is a more complex procedure and may be less available than PRP. The cost for a session of ACS may run $10,000-12,000.
Regenerative cellular therapy: stem cells
Stem cells are undifferentiated cells that can make copies of themselves and morph into other types of cells. In adults, there are a small number of these unspecialized cells that lie dormant in many tissues and organs. The concept that stem cells may be a source of renewable tissue for many parts of the body is the basis of these therapies.
Mesenchymal stem cells (MSCs), found in adipose tissue and bone marrow, are used for stem cell procedures. These cells are separated from the other tissue components and are injected into painful joints. In theory, stem cells initiate tissue regeneration in the joint. MSCs stimulate the production of growth factors and anti-inflammatory proteins. Studies provide some evidence that MSCs can improve joint pain, swelling and function in arthritic joints and are safe.
The prospects for repairing early arthritis and some chronic overuse injuries are promising. It is unlikely that stem cell therapy will improve bone-on-bone osteoarthritis.
At this point, there is no evidence that stem cells can regrow cartilage or restore tissue once it has been lost. We should keep in mind that the number of viable stem cells in bone marrow and adipose is small and diminishes with age. If viable stem cells could be isolated in a lab and cultured, the prospect of a positive result for the therapy would increase significantly. However, this is currently prohibited in the U.S., although it is done in much of the rest of the world.
Most insurance plans do not cover such regenerative cellular therapy. The cost for injection of a single knee with stem cells ranges from $5,000-6,000.
Cartilage repair and restoration
Injuries can result in small holes and tears in cartilage that can leave bare areas of bone. Over time, this can result in osteoarthritis. These small holes and tears can be filled in with repairing tissue. This results in pain relief, improved function, and the delay or prevention of future surgery. There are several techniques for repairing and restoring damaged cartilage.
Microfracture is a technique that involves the drilling of tiny holes in the layer of bone beneath the defect in the cartilage. This results in the formation of a blood clot and the eventual formation of fibrocartilage.
Fibrocartilage is not as durable or strong as the original hyaline cartilage it replaces. In the process of cartilage transplantation, a plug of healthy hyaline cartilage is taken from a healthy part of the joint or from a tissue bank. The hyaline plug is then transplanted into the cartilage defect.
The technique of Matrix-Associated Autologous Chondrocyte Implantation (MACI) involves the removal of a small piece of cartilage from a non-weight bearing area of the joint, such as the knee. It is shipped to a laboratory, where the harvested cartilage cells are grown on a membrane. The membrane sheet that results can then be cut to precisely fit the defect. There are several similar procedures that currently show promise in clinical trials.
Cartilage repair and restoration through transplantation is extraordinarily successful. In MACI implants, 85% integrate with the existing cartilage. Up to 88% of patients who undergo the procedure return to an active and even athletic life.
Autograft and allograft transplants have become primary treatment strategies for younger athletes with damaged cartilage. None of the cartilage repair and restoration techniques are intended to repair the damage caused by widespread osteoarthritis. In-network insurance coverage for a single-knee allograft ranges from $14,000-15,000.
Autografts are slightly less costly. Prices for MACI range from $40,000 upward.
Educated providers and patients
The booming industry of regenerative medicine has, until recently, been mostly unregulated. For this reason, it is essential that health care providers and health care consumers separate the research performed by reputable institutions from the claims made by some for-profit clinics that promote therapies of questionable value.
Although the full extent of its benefits has not been fully understood yet, regenerative medicine has shown great promise, particularly in the area of pain relief involving joints.
MARK SANNA, DC, ACRB Level II, FICC, is a member of the Chiropractic Summit and a board member of the Foundation for Chiropractic Progress. He is the president and CEO of Breakthrough Coaching and can be reached at mybreakthrough.com or 800-723-8423.