“Orthobiologics” is the term used for the liquid solutions that are injected directly into damaged musculoskeletal tissue. These materials are typically made from substances that are naturally found in your body and are used to help injuries such as broken bones, injured muscles, tendons, and ligaments strengthen and heal.
Our bodies are designed to repair damage. Unfortunately, various external and internal factors can get in the way of our bodies completely healing an injury. Regenexx orthobiologic treatments use your body’s natural healing agents to repair or mitigate damage by concentrating and focusing them at the precise site of your injury or pain. This approach allows for natural, efficacious healing without the need for surgery. In short, these procedures help overcome whatever barrier or threshold is needed to complete the repair process.
Bone-marrow Stem Cells
Our stem cells are incredibly powerful and play many roles. For example, these cells can turn into other types of cells and release substances that orchestrate a repair response. Stem cells work as our body’s primary means of repairing damage. While there are different types of stem cells, we use only the one with demonstrated efficacy – mesenchymal stem cells (MSC).
The most effective MSCs (based on current research literature) are derived from bone marrow. Despite what some people advertise, MSCs are currently the only source of tissue from which stem cells can be derived that are in compliance with FDA regulations. These stem cells are drawn from the back of the pelvis and have the capacity to turn into bone, muscles, tendons, ligaments, and in a limited way, cartilage. After the cells are drawn, they are processed, isolated, and concentrated in our lab to derive 5-20 times more stem cells per unit volume when compared to a bedside centrifuge machine that the majority of physicians outside of Regenexx use. These stem cells are then injected using precise image guidance (both live ultrasound and Xray) into injured or weak tissue to rebuild, repair, or mitigate the effects of the injury. When used in a skilled way, the joint will become more stable, less inflamed, and more functional. Our extensive research protocols using MSCs derived from bone marrow have shown excellent outcomes in treating most orthopedic injuries. We believe that at least 70% of all orthopedic surgeries can be replaced with this less invasive, safer strategy.
“My surgery for a 3 level (lumbar spine) fusion was scheduled and I was dragging my right leg due to an accident …I gave Regenexx a try. I had PRP on my lower back in February (2017). By July I was playing pickleball and riding my mountain bike. After that I had the same day stem cell procedure on my wrist due to an old injury that had turned into arthritis and limited me significantly. Twelve months later I am back throwing the football with my grandson”
— Bill J.
Culture Expanded Stem Cells
We practice the culture expansion (growth) of stem cells into larger quantities at our licensed site in Grand Cayman. This technology is used in select patients who have more severe orthopedic conditions, patients who want to treat multiple joints, and/or for patients who want to store and save cells for future treatments (stored at their current age). This procedure is not US FDA-approved, but is the subject of an FDA-approved phase 2 clinical trial and is permitted in Grand Cayman as the practice of medicine. A small number of Regenexx physicians (including at Regenexx Tampa Bay) are licensed to practice in the Cayman Islands and perform this advanced treatment.
In some cases, adipose or fat-derived stem cells can be used effectively as a part of a larger treatment plan for orthopedic injuries to create a fat graft that supports and holds in place other structures allowing them to heal appropriately. In the U.S., adipose-derived stem cells (which require advanced laboratory techniques) are FDA regulated as a drug and therefore require clinical trials for approval. This has not been done to date. However, adipose tissue (obtained via mini-liposuction in the buttock area) that has been "minimally manipulated" (often referred to as microfragmented fat) can be used as an adjunct or a stand-alone injectable material for cushion or support. One study found that using fat in this way was equivalent in terms of clinical outcomes to using concentrated bone marrow for patients with knee arthritis. But, to be clear, this is NOT really a "stem cell" procedure.
Platelet-rich plasma (PRP) is created by concentrating the platelets in your blood to enhance healing. These platelets have growth factors that can jump-start your normal healing process and encourage your body to heal itself. Our proprietary lab processing allows us to create customized and individualized products based on your unique issues to maximize the repair process. We refer to Regenexx PRP as SCP (super concentrated platelets). The difference between Regenexx’s PRP and most other PRP is visible. Standard fare PRP is reddish in color because it still contains a significant number of red blood cells. Regenexx’s PRP is amber in color due removal of the harmful red blood cells and also due to its higher concentration of growth factors that can be customized from 2-20 times above what a basic centrifuge machine can produce. Our outcomes have demonstrated that this super-concentrated PRP produces better tissue healing in tendon injuries and better stimulation of the local stem cells to promote healing.
“I want to offer your team of professional staff and most particularly, to esteemed Dr. Leiber, my profound and most sincere gratitude. It is from your services and caring that I am now finding my pathway to a new lease on wellness. Dr. Leiber’s outstanding and impeccable knowledge and gifts of stimulating self-healing have been the spark to ignite my body’s much hoped for self-repair and renewal abilities. I am indebted to your services and look forward to upcoming and all future treatments!”
Platelet lysate is a highly specialized derivative of PRP. Normal PRP isolates platelets from the blood while slowly releasing growth factors into the site of the injury over the course of approximately one week. Our research shows that in some cases, a faster, more intense release of healing factors creates an improved healing response. By stripping all of the growth factors from platelets and making them available for immediate use, platelet lysate accomplishes this goal. As we have learned better ways to encourage the fast release of growth factors over the years, Regenexx’s proprietary platelet-lysate processing technology is now on its fifth generation. There are times we combine Platelet Lysate with SCP to get both a fast and slow release of growth factors at the same time.
While there is not nearly as much long-term research regarding cytokines, the initial results are promising. Regenexx uses Alpha 2 Macroglobulin (A2M), a cytokine that reduces inflammation and removes from tissues certain chemicals that have been shown to be destructive to cartilage. A2M is derived from a different part of your blood than PRP and shows tremendous promise as a means of treating or preventing osteoarthritis. Regenexx continues to lead the way in researching new ways to better use the body’s natural healing agents to treat orthopedic injuries.
Extra-cellular Matrix (ECM)
An extra-cellular matrix is best described as a scaffold on which cells can grow. We use an ECM that is derived from amniotic membrane that contains proteins and growth factors. We believe that this matrix can help platelets or stem cells in certain clinical scenarios such as tendon repair. It should be noted that the amniotic ECM product is NOT a stem cell procedure. This is commonly fraudulently advertised as a stem cell product by providers outside of the Regenexx network. No living stem cells are found in these products and if they did contain any, they would be required to obtain FDA approval – which has yet to occur.