Connective Tissue Matrix Injections
What Is Regenerative Medicine?
Regenerative medicine has become increasingly popular over the past decade in helping people avoid surgery and return to their active lifestyles. Frequently, these procedures are labeled as “stem cell therapies”. These nonsurgical procedures have the potential to help with inflammation and in some situations assist in the body’s natural healing by activating and enhancing other cells that help in repairing damaged tissue. Many patients facing surgery have been able to avoid or postpone such intervention. Please be cautious of faulty advertising. Many available injections do not possess “live cells”. Currently, the only true “stem cell” injection that is available in the United States under FDA regulatory guidelines is bone marrow aspirate (BMAC) which is derived from your own cells and reinjected on the same treatment date. The available treatments and explanations of such treatments are offered below.
Platelet Rich Plasma (PRP):
Over the past decade, research has demonstrated that the body has the ability to heal and treat itself. Platelet-rich plasma therapy is a form of regenerative medicine. Many professional athletes such as Tiger Woods have received PRP for several injuries including sprained knees and chronic tendon injuries to help speed and aid recovery and allow a faster return to play and activity.
What is PRP?
Blood is mainly composed of a liquid substance known as plasma but also has small solid cellular components mixed together. These cellular components include red cells, white cells and platelets. Platelets are best known for their ability to clot blood and stop bleeding. Platelets also are made of hundreds of proteins called growth factors which are important in the healing of injured parts. These factors then stimulate and increase the presence of other reparative cells to speed healing. Platelet rich plasma is therefore a more concentrated form than that is found in normal blood. It is made by taking a sample of blood and putting it into a centrifuge which then separates the different contents and leaves only the concentrated platelets behind. By concentrating the platelets, this also concentrates the growth factors 5-10 times greater thus enhancing the healing.
How Does PRP Work?
The exact mechanism of how PRP works is not completely understood yet. Research would suggest that the increased concentration of growth factors speeds up the healing process. It therefore uses the person’s own healing system to improve and enhance their musculoskeletal problems. To function properly, the PRP needs to be injected or placed at the site of the damaged tissue or injured joint. Injections can therefore be placed into tendon insertions to treat common problems such as tennis elbow, golfers elbow, patellar tendonitis or rotator cuff tendonitis. It may also be injected into joints to help treat knee arthritis, shoulder arthritis or hip arthritis. To make the injection more accurate, in office ultrasound can be utilized for a more precise treatment. The effectiveness of PRP can vary with greater success and research supporting its use in chronic tendon injuries. In a small study looking at knee arthritis, PRP was shown to have better efficacy than hyaluronic acid treatment for knee pain. More research is forthcoming but given the fact that the injection is derived from the patient’s own cells, it is considered a relatively low risk treatment with a lot of upside and potential. The main risk of PRP injection is pain at the injection site for several days post injection.
Bone Marrow Aspirate Stem Cell Concentrate (BMAC)
Bone marrow aspirate stem cell concentrate is a substance from your bone marrow that contains growth factors and anti-inflammatory proteins that can help promote healing, reduce inflammation and improve pain related to tendon injuries or arthritis. While stem cells can be derived from multiple source in your body, the bone marrow has the richest concentration of such reparative cells. Currently in the United States, this is the only true “stem cell” therapy where actual live cells can be injected back into your damaged or injured body part. It is collected by inserting a needle into your hip (iliac crest) or other long bone (femur, humerus) and then processed by spinning the collected fluid into a centrifuge to concentrate the stem cells and remove unwanted fluid. Once concentrated, it can then be reinjected back into the joint or diseased area/tendon. It can be good option for those patients who have failed physical therapy and other injections or when surgery is trying to be avoided or quite simply cannot be performed due to medical issues. Conditions that can be treated include shoulder arthritis, knee arthritis, and rotator cuff tears. Risk of the injection include local irritation from the aspiration site and local pain at the injection site for several days. Results can vary but can occasionally take 1-2 months for peak efficacy.
Connective Tissue Matrix
Amnion, chorion, amniotic fluid and umbilical cord are distinct placental and extracellular matrix tissues have been used for treatment of several orthopedic conditions. These substances are rich in collagen, proteoglycans and others molecules that aid in healing and repair. Amniotic tissue in particular has been used for over 100 years to treat help treat burns, chronic wounds and ophthalmic (eye) conditions with favorable outcomes and no adverse events reported in the literature.Amniotic membrane provides a variety of functions including the synthesis of growth factors, cytokines and proteins that help regulate and control inflammation. It also contains undifferentiated cells that could aid in healing and serve as “stem cells”. It has been shown to exert an anti-inflammatory effect by blocking the inflammatory cascade that occurs. In particular it is able to block cytokines which are protein mediators that induce pain and inflammation. The use of amnion therefore, can help dampen and improve healing and lessen pain in patients.
The FDA has classified amnion as an allograft tissue under Human Cells,Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 361 and to meet the criteria for use it cannot be manipulated or combined with other cells or tissues in the United States. Amniotic tissue is commercially available in several forms with the majority being reconstituted and not having “live cells” nor can it be advertised as such.While its applications appear promising, very limited evidence is currently available regarding the overall efficacy and indications. In a recent study conducted at the Hospital for Special Surgery in New York, over 200 patients were randomized to receive amnion injection, saline injection or hyaluronic acid injection for knee arthritis. Those patients that received amnion had statistically significant improvements in pain and function at 6 months. This treatment may be a more viable and longer lasting option than steroid for patients trying to avoid surgery. Dr. Badman currently uses CTM products (CTMbiomedical.com) and serves on their medical advisor board. He holds stock ownership in the company as disclosure.
Are These Injections Safe?
The risk of an injection are very minimal. For PRP, a blood sample will be necessary prior to the procedure. This is done in office and takes about 5 minutes with about 30-40cc of blood taken. The risk of PRP includes irritation from the blood donor site and local irritation and pain following the injection. Because local anesthetic cannot be given with the PRP at the same time, the joint or soft tissue area injected can be inflamed for 24-48 hours post injection. Infection, although possible, is extremely rare. Results will be demonstrated over the course of the next 6 weeks.
Patients considering bone marrow aspirate will have a higher donor site risk. Hip aspiration can irritate some sensory nerves around the pelvis and cause local pain from the donor site for several days. This can be done in office or a surgery center where local anesthesia and general sedation can be performed to keep you more comfortable. The site of the injection can be painful for several days with mild bruising in the area. Infection, although possible, is extremely rare.
For those considering extracellular matrix injections, all materials used are terminally sterilized and processed. All donors go thru a rigorous screening process as dictated by the FDA and American Association of Tissue Banks (AATB). Irritation at the injection site can occur for several days. Infection, while possible, is extremely rare.
Am I A Candidate?
Patients suffering from any kind of joint, tendon, or ligament pain may be considered as candidates regenerative medicine therapy. Patients with severe end stage degenerative osteoarthritis may not be the most ideal candidates. These therapies DO NOT regrow cartilage, therefore, once the joint is completely destroyed joint replacement may be the only viable option to alleviate pain completely. These therapies are intended for patients earlier In their disease course or when surgery is simply not an option. Upon evaluation, Dr. Badman may be able to provide you with recommendations for other types of treatment options.
Does Insurance Cover These Injections?
Most insurance companies do not cover these treatments at this time. As such, this is fee for service due at the time of treatment. Many insurance companies, however, may cover the initial consultation as well as some aspects of the treatment, such as the injection fee, radiographs, and use of ultrasound guidance if necessary during your appointment.
Dr. Badman can help review the advantages, costs, and indications for the various treatments available and help you select which is best for you.
How Much Do These Injections Cost?
Extracellular matrix injection prices are approximately 2000.00 for 2cc of material. This covers the cost of the injection, office visit and use of ultrasound to administer the injection. A 2cc injection is standard size for a large joint injection.
PRP injections cost 750.00. This covers the cost of the blood draw, the price of the PRP kit and office visit.
BMAC injections are 3500.00. This covers the cost of the aspiration and injection and local anesthetic and imaging necessary to complete the procedure.
Dr. Badman strives to provide this treatment as cost-effectively and competitive as possible, with costs comparing favorably with other nationally prominent specialists