What is Interventional Orthobiologics?
Interventional Orthobiologics is a subspecialty of Interventional Pain Management and a medical subspecialty gaining increasing attention in the most prestigious medical institutions in the nation such as Mayo Clinic, Harvard University, Johns Hopkins University and Yale University, for the treatment of musculoskeletal conditions. This new modality of care utilizes the potential of Orthobiologics, which are products delivered by guided injections using fluoroscopy or ultrasound into the affected area. It represents a promising minimally invasive treatment approach. The use of high dose cortisone injections still used in many so-called “Pain Clinics” and other destructive procedures such as ablation are becoming obsolete!
The Orthobiologics used in this modality of care, are derived from your own body and include blood derivatives such as Platelet Rich Plasma (PRP), as well as cells derived from various sources and tissues such as Bone Marrow Aspirate Concentrate (BMAC) and subcutaneous fat (Regenikine). The goals of using these products is to hopefully improved and expedite healing.
On the other hand, the use of steroids injection in high doses as commonly used in those so-called “Pain Clinics” is concerning, since it is associated with tendon and ligament degeneration and rupture and also with toxicity to the chondrocytes (cartilage cells) when used in joint injections. At our office when we use steroid injections, we always inject nanogram doses (very small doses).
In our office, the following Orthobiologics products are used:
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Platelet Rich Plasma (PRP)
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Progenikine
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BMAC
You may ask what is the beauty of Orthobiologics and what exactly are they?
The beauty of the above products used in our office is that they are prepared from samples of blood or bone marrow or fatty tissue obtained from your own body, so there is no chance of disease transmission or allergic reaction! The Orthobiologics are prepared and injected into the area to be treated on the same visit without adding any foreign substance and with minimal manipulation. This makes them very safe and legal. They are injected into the precise locations needed using x-ray and/or ultrasound guidance.
Interventional Orthobiologic Medicine is a game-changing area of medicine with the potential to help many patients. It offers an alternative solution for those who have musculoskeletal conditions like arthritic joints, meniscus tears, rupture ligaments or tendons, etc., that were beyond hope of repair, using simple conventional nonsurgical means. These modern cutting edge techniques may sometimes but not always help you postpone or avoid surgery all together when due to your health condition surgery would be very risky.
In our office, we use Interventional Orthobiologic techniques to treat exclusively common musculoskeletal conditions, where they will hopefully promote healing. These techniques show promise although more research is needed. These modalities have the potential to improve painful knee conditions, painful shoulder conditions, painful ligaments, and tendon tears, painful bursitis, etc. These techniques are very new, but they are being used at major universities both in the USA and abroad. We wanted to make them available locally to our patients. As mentioned above these techniques appear promising, but more research is needed.
Discover the Power of Orthobiologic Therapies!
“Orthobiologics”, refers to the use of autologous unmodified biological substances such as Platelet Rich Plasma (PRP), Bone Marrow Concentrate (BMC), Lipogems, and Progenikine to help musculoskeletal and ligamentous injuries so that they may heal quicker. They are used to improve the healing of fractured bones and injured muscles, tendons, and ligaments. These orthobiologic substances are prepared from blood, bone marrow, or fat obtained from your own body. With its many healing functions Orthobiologic therapy has proven to be a viable treatment alternative for many orthopedic-related problems.
Orthobiologic therapy is not for Everyone!
In Saint Augustine Florida, it was Dr. Edward Dieguez Jr. MD, an Anesthesiologist, and Interventional Pain Specialist, the one who introduced these non-surgical modalities. He is committed to the nonsurgical and non-opioid treatment of painful joints, spine conditions, and sports injuries. Dr. Dieguez has used this modality of care in our Saint Augustine Florida office for over 12 years.
We do not want anyone to think this is a magical cure because it is not! We offer these as an alternative promising modality with the potential to help many people. It shows promise although more research is needed.
The success rate of these procedures varies and this success rate increases when the patients are picked correctly and when the latest techniques are used and performed by experts on the subject such as Dr. Dieguez. We do not make false claims about the procedures we perform and yes, they do not work for everyone and there are failures. Additionally, even in successful patients, the procedure may have to be repeated years later, just like at times you have to have a revision of a knee replacement because it is not working right or because the prosthesis is worn out or it has loosened up. Remember, nothing lasts forever! There are failures in any treatment even in the best hands. Additionally, not all patients are good candidates for these Orthobiologic procedures. That is why it is so important to pick the patients correctly and not all physicians have the same training. You want to give patients the best chance of success. However, the beauty of these procedures using autologous minimally manipulated products is that in trained hands the risk is minimal.
Here are the rules we follow when using Orthobiologics.
In this ever-changing field, we always strive to stay within FDA and Florida Board of Medicine regulations at all times. We want to bring you the latest treatments not frowned upon by the FDA and the Board of Medicine. When using orthobiologics in our treatments you can be assured of the following:
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All products are harvested from your own body. We mainly use autologous Bone Marrow Aspirate Concentrate (BMAC) harvested from your own bone marrow and Platelet Rich Plasma (PRP) harvested from peripheral blood and Lipogems and Regenekine harvesting fat from your subcutaneous tissue.
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We do not manipulate any of the products we use in any way shape or form, since that would constitute the creation of a drug and this is a highly regulated process by the FDA.
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Nothing is added to the PRP or the BMAC or the Lipogems or the Regenikine for the same reason above mention. It would constitute the creation of a drug and this is a highly regulated process by the FDA.
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All procedures are performed by Dr. Dieguez himself, under local anesthesia in one seating. All is done in our procedure room under the strictest aseptic techniques. It takes about an hour to an hour and a half. You walk in and you walk out!
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We do not make false claims about the procedures we perform and I repeat, yes they do not work for everyone and there are failures. The failure rate varies.
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We do not use any amniotic fluid products or umbilical cord products or exosomes.
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We only treat musculoskeletal conditions.
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All injections are performed under fluoroscopic or ultrasound guidance.
The problems practitioners are facing.
With all of the medical potential, also comes novelty and uncertainty as this field matures. There are a small number of unscrupulous actors who have seized on the clinical promise of these procedures while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products. These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This puts the entire field of orthobiologic medicine at risk. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.
At the same time, it is incumbent upon the FDA to separate with bright lines new treatments that are: 1) medical products subject to the FDA’s regulation and 2) therapies that are individualized by surgeons/physicians in such a way that they are not subject to FDA regulation. This is the difference between what is legal and what is not.
This is why we do not use any umbilical cord products or amniotic fluid products, exosomes, and many other dubious products being sold out there. They are not FDA-approved. They may either transmit disease, or there are no live and functional cells in those umbilical cord blood products or amniotic fluid products that are being sold. This is something that Dr. Chris Centeno from Regenex in Denver Colorado has confirmed and now Lisa Fortier's lab at Cornell has also confirmed. Marketing and using these products is basically fraudulent.
The therapies that we use are individualized and are not subject to FDA regulation. This applies to orthobiologics when they are taken from and given back to the same individual or when they do not undergo significant manufacturing, are intended to perform the same basic functions and are not combined with another drug or device, and their benefits and risks are well understood. In these circumstances, the products may not require premarket review under current law. We do not manipulate orthobiologics, in any way shape, or form. That would constitute the “creation of a drug” according to the law and this is a highly regulated process by the FDA and other agencies.
Warning!
Please be aware that we are not one of those so-called “pain clinics”! We treat the different musculoskeletal, orthopedic, and spine conditions and sports injuries using Orthobiologics and Prolotherapy and at times we also use conventional injections techniques using minimal dose steroids using precision guidance.
Having worked for the Florida Department of Health as an expert witness for the prosecution services unit reviewing cases and being very aware of the addiction problem we have in our country, Dr. Dieguez rarely if ever prescribes narcotics and other controlled addictive medications. If he ever does, it is only if absolutely necessary after a minor surgical procedure and never for longer than 3 days or very rarely 5 days.
With that been said, if what you are looking for are narcotics or other controlled substances, don’t expect to get them in this office. Don't waste my time or yours. Or your money for that matter! This is not a "Pain Clinic"! Here you will go out empty-handed. And remember, we will not hesitate in reporting drug seekers to the authorities. Additionally, we do not prescribe Marijuana.
The Orthobiologic Clinic provides Interventional Orthobiologic services to:
Ponte Vedra, Pontevedra Beach, Neptune Beach, Mayport, Nocatee, Orange Park, Fleming Island, Asbury Lake, Green Cove Springs, Jacksonville, Fernandina Beach, Jacksonville Beach, Saint Johns, Sawgrass, Villano Beach, Fruit Cove, Saint Augustine, Saint Augustine Beach, Palatka, Palm Coast, Flager Beach, Beverly Beach & beyond