Autologous conditioned serum

Last updated

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]

Contents

Medical use

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]

Process

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.

History

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.

Related Research Articles

<span class="mw-page-title-main">Immune thrombocytopenic purpura</span> Medical condition with rash and bleeding risk

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.

<span class="mw-page-title-main">Ozone therapy</span> Unproven alternative medicine

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."

<span class="mw-page-title-main">Osteoarthritis</span> Form of arthritis caused by degeneration of joints

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.

<span class="mw-page-title-main">Duloxetine</span> Antidepressant medication used also for treatment of anxiety and chronic pain

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.

<span class="mw-page-title-main">Hematopoietic stem cell transplantation</span> Medical procedure to replace blood or immune stem cells

Hematopoietic stem-cell transplantation (HSCT) is the transplantation of multipotent hematopoietic stem cells, usually derived from bone marrow, peripheral blood, or umbilical cord blood, in order to replicate inside a patient and produce additional normal blood cells. HSCT may be autologous, syngeneic, or allogeneic.

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.

<span class="mw-page-title-main">Apheresis</span> Medical techniques to separate one or more components of blood

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.

Prolotherapy, also called proliferation therapy, is an injection-based treatment used in chronic musculoskeletal conditions. It has been characterised as an alternative medicine practice.

<span class="mw-page-title-main">Meloxicam</span> Nonsteroidal anti-inflammatory drug (NSAID)

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.

<span class="mw-page-title-main">Blood-spinning</span> Medical procedure

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.

Therapeutic ultrasound refers generally to any type of ultrasonic procedure that uses ultrasound for therapeutic benefit. Physiotherapeutic ultrasound was introduced into clinical practice in the 1950s, with lithotripsy introduced in the 1980s. Others are at various stages in transitioning from research to clinical use: HIFU, targeted ultrasound drug delivery, trans-dermal ultrasound drug delivery, ultrasound hemostasis, cancer therapy, and ultrasound assisted thrombolysis It may use focused ultrasound or unfocused ultrasound.

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.

<span class="mw-page-title-main">Platelet-rich plasma</span> Blood product used in transfusion medicine

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.

<span class="mw-page-title-main">Collagen induction therapy</span> Cosmetic procedure

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.

<i>United States v. Regenerative Sciences, LLC</i>

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.

Betibeglogene autotemcel, sold under the brand name Zynteglo, is a gene therapy for the treatment for beta thalassemia. It was developed by Bluebird Bio and was given breakthrough therapy designation by the US Food and Drug Administration in February 2015.

References

  1. 1 2 3 4 5 6 Wehling, P; Evans, C; Wehling, J; Maixner, W (August 2017). "Effectiveness of intra-articular therapies in osteoarthritis: a literature review". Therapeutic Advances in Musculoskeletal Disease. 9 (8): 183–196. doi:10.1177/1759720X17712695. PMC   5557186 . PMID   28835778. Limited data due to less expanded use and nonconsideration in guidelines.
  2. "Osteoarthritis Emerging Therapies Epocrates Online". online.epocrates.com. Retrieved 30 September 2018.
  3. 1 2 3 Kyler, Steve (August 15, 2012). "NBA AM: The Next Nightmare In The NBA". hoopsworld.com. USA Today. Archived from the original on 2012-08-16. Retrieved 2012-08-17.
  4. 1 2 Thompson, Teri (December 31, 2011). "A-Rod doc has pal who dealt 'cream'". New York Daily News. Archived from the original on 2013-02-08. Retrieved 2012-08-14.
  5. 1 2 Mitchell, John N. (August 18, 2012). "Bynum's knee treatment gains acceptance in U.S." The Philadelphia Inquirer. Archived from the original on 2015-09-14. Retrieved 2012-08-25.
  6. Torrero, JI; Martinez, C (July 2015). "New developments in the treatment of osteoarthritis focus on biologic agents". Open Access Rheumatology: Research and Reviews. 7 (7): 33–43. doi: 10.2147/OARRR.S50058 . PMC   5045124 . PMID   27790043.
  7. 1 2 Lehrer, Jonah (April 11, 2012). "Why Did Kobe Go to Germany?". grantland.com. ESPN Internet Ventures. Archived from the original on 2012-08-28. Retrieved 2012-08-14.