Autologous conditioned serum, also known as Orthokine and Regenokine, is an experimental procedure in which a person's own blood is extracted, manipulated, and then reintroduced with claimed benefit in osteoarthritis. [1] There is limited evidence on safety and effectiveness as of 2017. [1] It is not included in medical guidelines as of 2017. [1] It is a type of autologous blood therapy. [1]
There is limited evidence on safety and effectiveness as of 2017. [1] There is tentative evidence in osteoarthritis. [2] Its use has not been recommended or considered by the Osteoarthritis Research Society International. [1]
The process removes about 2 US fluid ounces (59 ml) of blood from a patient's arm, which is then incubated at a slightly raised temperature.[ citation needed ] The liquid is then placed in a centrifuge until its constituent parts are separated. That serum is injected into the patient's affected area.
Autologous conditioned serum is a patented method developed by molecular biologist Julio Reinecke and Peter Wehling, a spinal surgeon in Düsseldorf, Germany. [3] [4] Orthokine was first approved for use in Germany in 2003. [5] Orthokine differs from a similar procedure with platelet-rich plasma (PRP), [6] where platelets are targeted instead of the interleukin antagonist. Also, PRP does not require the blood to be heated as Orthokine does.[ citation needed ]
As of August 2012, about 60,000 patients worldwide have received the treatment. [5] Americans have traveled to Germany for the treatment, which has not been approved by the U.S. Food and Drug Administration (FDA). [7] [4] Freddie Fu, a professor of orthopedic surgery at the University of Pittsburgh, said more high-quality independent trials proving the procedure's effectiveness are needed before the FDA approves. National Basketball Association player Kobe Bryant traveled to Germany to have the procedure performed. [7] [3] Some basketball fans refer to the procedure as the "Kobe Procedure". [3]
The procedure costs €6,000 (about $7,400) as of July 2012 and is not covered by health insurance.
Immune thrombocytopenic purpura (ITP), also known as idiopathic thrombocytopenic purpura or immune thrombocytopenia, is an autoimmune primary disorder of hemostasis characterized by a low platelet count in the absence of other causes. ITP often results in an increased risk of bleeding from mucosal surfaces or the skin. Depending on which age group is affected, ITP causes two distinct clinical syndromes: an acute form observed in children and a chronic form in adults. Acute ITP often follows a viral infection and is typically self-limited, while the more chronic form does not yet have a specific identified cause. Nevertheless, the pathogenesis of ITP is similar in both syndromes involving antibodies against various platelet surface antigens such as glycoproteins.
Ozone therapy is an alternative medical treatment that introduces ozone or ozonides to the body. The United States Food and Drug Administration (FDA) prohibits all medical uses of ozone "in any medical condition for which there is no proof of safety and effectiveness", stating "ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals."
Osteoarthritis (OA) is a type of degenerative joint disease that results from breakdown of joint cartilage and underlying bone. It is believed to be the fourth leading cause of disability in the world, affecting 1 in 7 adults in the United States alone. The most common symptoms are joint pain and stiffness. Usually the symptoms progress slowly over years. Other symptoms may include joint swelling, decreased range of motion, and, when the back is affected, weakness or numbness of the arms and legs. The most commonly involved joints are the two near the ends of the fingers and the joint at the base of the thumbs, the knee and hip joints, and the joints of the neck and lower back. The symptoms can interfere with work and normal daily activities. Unlike some other types of arthritis, only the joints, not internal organs, are affected.
Duloxetine, sold under the brand name Cymbalta among others, is a medication used to treat major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, fibromyalgia, neuropathic pain and central sensitization. It is taken by mouth.
Glucosamine (C6H13NO5) is an amino sugar and a prominent precursor in the biochemical synthesis of glycosylated proteins and lipids. Glucosamine is part of the structure of two polysaccharides, chitosan and chitin. Glucosamine is one of the most abundant monosaccharides. Produced commercially by the hydrolysis of shellfish exoskeletons or, less commonly, by fermentation of a grain such as corn or wheat, glucosamine has many names depending on country.
In immunology, antiserum is a blood serum containing antibodies that is used to spread passive immunity to many diseases via blood donation (plasmapheresis). For example, convalescent serum, passive antibody transfusion from a previous human survivor, used to be the only known effective treatment for ebola infection with a high success rate of 7 out of 8 patients surviving.
Apheresis is a medical technology in which the blood of a person is passed through an apparatus that separates out one particular constituent and returns the remainder to the circulation. It is thus an extracorporeal therapy.
In medicine, a joint injection is a procedure used in the treatment of inflammatory joint conditions, such as rheumatoid arthritis, psoriatic arthritis, gout, tendinitis, bursitis, Carpal Tunnel Syndrome, and occasionally osteoarthritis. A hypodermic needle is injected into the affected joint where it delivers a dose of any one of many anti-inflammatory agents, the most common of which are corticosteroids. Hyaluronic acid, because of its high viscosity, is sometimes used to replace bursa fluids. The technique may be used to also withdraw excess fluid from the joint.
Prolotherapy, also called proliferation therapy, is an injection-based treatment used in chronic musculoskeletal conditions. It has been characterised as an alternative medicine practice.
Meloxicam, sold under the brand name Mobic among others, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation in rheumatic diseases and osteoarthritis. It is used by mouth or by injection into a vein. It is recommended that it be used for as short a period as possible and at a low dose.
Asparaginase is an enzyme that is used as a medication and in food manufacturing. As a medication, L-asparaginase is used to treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). It is given by injection into a vein, or muscle. A pegylated version is also available. In food manufacturing it is used to decrease acrylamide.
Blood-spinning is a medical procedure used to shorten the healing time of an injury. Small samples of the patient's blood are taken and spun in a centrifuge, allowing platelets and blood serum to be isolated from other blood components. The platelets and plasma are then combined forming platelet-rich plasma (PRP), which has high concentrations of natural growth factors. The PRP sample can then be injected into the patient's injury, which may help reduce pain and improve recovery speeds.
Stem-cell therapy uses stem cells to treat or prevent a disease or condition. As of 2024, the only FDA-approved therapy using stem cells is hematopoietic stem cell transplantation. This usually takes the form of a bone marrow or peripheral blood stem cell transplantation, but the cells can also be derived from umbilical cord blood. Research is underway to develop various sources for stem cells as well as to apply stem-cell treatments for neurodegenerative diseases and conditions such as diabetes and heart disease.
Articular cartilage, most notably that which is found in the knee joint, is generally characterized by very low friction, high wear resistance, and poor regenerative qualities. It is responsible for much of the compressive resistance and load bearing qualities of the knee joint and, without it, walking is painful to impossible. Osteoarthritis is a common condition of cartilage failure that can lead to limited range of motion, bone damage and invariably, pain. Due to a combination of acute stress and chronic fatigue, osteoarthritis directly manifests itself in a wearing away of the articular surface and, in extreme cases, bone can be exposed in the joint. Some additional examples of cartilage failure mechanisms include cellular matrix linkage rupture, chondrocyte protein synthesis inhibition, and chondrocyte apoptosis. There are several different repair options available for cartilage damage or failure.
Autologous blood therapy, also known as autologous blood injection or autohemotherapy, comprises certain types of hemotherapy using a person's own blood. There are several kinds, the original belonging only to traditional medicine, alternative medicine, and some newer kind of medicine under investigation. The original, unscientific form is "the immediate intramuscular or subcutaneous reinjection of freshly drawn autologous blood". It was used in the early 20th century, when some physicians believed that it had efficacy and a logical mechanism of action; it was abandoned as advancing science made clear that it lacked those.
Platelet-rich plasma (PRP), also known as autologous conditioned plasma, is a concentrate of plasma protein derived from whole blood, centrifuged to remove red blood cells but retaining platelets. Though promoted for treating various medical conditions, evidence of its benefits was mixed as of 2020, showing effectiveness in certain conditions and ineffectiveness in others.
Collagen induction therapy (CIT), also known as microneedling, dermarolling, or skin needling, is a cosmetic procedure that involves repeatedly puncturing the skin with tiny, sterile needles. CIT should be separated from other contexts in which microneedling devices are used on the skin.
United States of America v. Regenerative Sciences, LLC, 741 F.3d 1314, was a decision in the United States Court of Appeals for the District of Columbia Circuit filed on February 4, 2014 concerning more than minimally manipulated cell therapies and whether they are considered part of medical practice or a drug, the latter subjecting it to regulation under the Food and Drug Administration (FDA). Regenerative Sciences LLC marketed a therapy procedure called Regenexx-C for the treatment of arthritis and orthopedic injury that involved extraction and culture of mesenchymal stem cells from the same patient which were later reinjected. In 2008, The FDA notified Regenerative Sciences LLC that the procedure may not be in compliance with their regulation using an Untitled Letter, which began a series of suits and counter suits, leading to the 2014 decision upholding the FDA’s regulation of more than minimally manipulated stem cell therapies.
Platelet-rich fibrin (PRF) or leukocyte- and platelet-rich fibrin (L-PRF) is a derivative of PRP where autologous platelets and leukocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue and is used as a tissue-engineering scaffold in oral and maxillofacial surgeries. PRF falls under FDA Product Code KST, labeling it as a blood draw/Hematology product classifying it as 510(k) exempt.
Afamitresgene autoleucel, sold under the brand name Tecelra is a T cell immunotherapy used for the treatment of synovial sarcoma. It is a T cell receptor (TCR) gene therapy. It is administered as a single intravenous dose.
Limited data due to less expanded use and nonconsideration in guidelines.