NEW:
Indication extended to include use for adolescents with closed epiphyseal growth plate (EU + CH)
NEW:
Indication extended to include use for adolescents with closed epiphyseal growth plate (EU + CH)
THE ACI WITH SPHEROID TECHNOLOGY
A common consequence of cartilage defects is swelling, pain, or immobility of the knee joint, which in the long term can lead to a reduction in weight-bearing capacity and even mobility. There are various treatment options. One of them is the so-called autologous chondrocyte implantation (ACI).
ACI has been around since the mid-1990s and has been steadily gaining popularity since around 2005. Most often it is used to treat cartilage defects in the knee, the ankle or the hip.
Within the method of ACI, CO.DON AG has developed a special technology – the spheroid technology: Three-dimensional cartilage cell implants – the spheroids – consisting of healthy cartilage cells and extracellular matrix are produced ex vivo in a laboratory and transplanted back into the cartilage defect to form new cartilage tissue.
Derived from this technology is the name of the product: SPHEROX. Its special feature: Spherox is 100% autologous, only the patient’s own cartilage cells are used for its production.of
WHAT EXACTLY ARE SPHEROIDS?
Spheroids are spherical cartilage cell implants made from human chondrocytes and extracellular matrix to treat cartilage defects in the (knee) joint. Over a period of about 6 – 8 weeks they are produced in a laboratory and afterwards implanted as Spherox into the cartilage defect.
The model shows spheroids directly after implantation into the cartilage defect in the knee joint (model enlarged). Move the model with the mouse button and zoom in by holding down the CTRL key.
HOW ARE SPHEROIDS APPLIED?
The spheroids are applied evenly into the defect. Just a few minutes later, they self-adhere to the subchondral bone. After about 20 minutes, the process is complete and the spheroids adhere firmly.
The model shows spheroids approx. 20 minutes after implantation into the cartilage defect of the knee joint (model enlarged).
WHAT DO SPHEROIDS DO IN THE DEFECT?
During the following weeks and months after the implantation of the spheroids (Spherox), new hyaline-like cartilage gradually forms and integrates into the existing, healthy catilage. After successful treatment and personalised rehabilitation, the knee can bear weight again.
The model shows how new hyaline-like cartilage tissue has formed in the cartilage defect.
Indication extended to include use for adolescents with closed epiphyseal growth plate (EU + CH)
Learn more and check out the publication „Matrix-Associated Autologous Chondrocyte Implantation Is an Effective Treatment at Midterm Follow-up in Adolescents and Young Adults“ by Arnd Hoburg, Ingo, Konrad Körsmeier, Rainer Siebold, Philipp Niemeyer, Stefan Fickert , Klaus Ruhnau
See the patient story of a young girl, treated with Spherox
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When twelve-year-old Anna is playing with her dog, she twists her left knee. An operation at the hospital does not bring the hoped for solution: the pain remains and she is threatened with an artificial knee joint. A new treatment method could help, but it is – at that time – only indicated fort he use in adults. A long struggle begins.
QUESTIONS ABOUT ACI ANSWERED BY THE EXPERT
Dr. Arnd Hoburg, an experienced user of ACI, works in the Knee Surgery Section at MedCenter 360° Berlin. Find out from him how ACI works, what results it can achieve and for whom it is suitable.
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WHich requirements ARE NECESSARY FOR AN ACI TREATMENT?
Which conditions should be considered for an ACI?
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HOW IS THE TREATMENT CARRIED OUT?
Dr. Hoburg explains the method of ACI, how the treatment is carried out and what results can be expected.
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WHAT PROCEDURES ARE NECESSARY FOR THE TREAMENT WITH ACI AND WHAT HAPPENS AFTERWARDS?
What procedures are necessary for ACI, how does the procedure looks like, what are the steps after ACI, and how long does the rehabilitation take?
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WHAT RESULTS CAN BE EXPECTED AFTER AN ACI TREATMENT?
What results can be expected from ACI? How does the patient feel after the treatment?
PATIENTS TELL THEIR STORY
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Artificial knee joint or cartilage cell therapy? Christian Florkiw-Jenkner talks about the treatment of his cartilage defect with SPHEROX and how it helped him to play sports again without pain.
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Klara Tomsova cannot imagine her life without sport. Severe pain in her knee, forces her to give it up. Until a treatment with SPHEROX enabled her to return to an active life.
Information for patients on knorpelexperte.de
The information website for patients and those interested in the topic of cartilage defects offers a lot of interetsting information and possible treatment options.
Co.don AG - Come closer
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Get an insight into our company, our technologies and our mission: to enable patients to live active lives through personalised cartilage cell therapy.
The company brochure gives you an overview of the focus and competences of CO.DON AG.
Name of the medicinal product: Spherox 10-70 spheroids/cm2 implantation suspension; active ingredient: spheroids of human autologous matrix-associated chondrocytes. Composition of medicinal product: 10-70 spheroids/cm2 defect suspended in isotonic sodium chloride solution. Therapeutic indication: Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults and adolescents with closed epiphyseal growth plate in the affected joint. Contraindications: Patients with not fully closed epiphyseal growth plate in the affected joint, primary (generalised) osteoarthritis, advanced osteoarthritis of the affected joint (exceeding grade II according to Kellgren and Lawrence), infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV I/II. Undesirable effects: Information on adverse reactions from clinical trials and a non-interventional study in adolescents as well as from post-marketing experience are available. In general, the adverse reactions in paediatric patients were similar in frequency and type to those seen in adult patients. Adverse reactions associated with Spherox: common adverse reactions: joint effusion, arthralgia, joint swelling, bone-marrow oedema, pain. Uncommon adverse reactions: chondromalacia, joint noise, joint lock, synovial cyst, chondropathy, synovitis, loose body in the joint, gait disturbance, hypertrophy, graft loss. Rare adverse reactions: cellulitis, osteomyelitis, hypersensitivity, osteochondrosis, osteonecrosis, osteophyte formation, arthritis infective, graft delamination, implant site infection, infrapatellar fat pad inflammation. Not known adverse reactions: arthrofibrosis. For further information, refer to Summary of Product Characteristics and Package Leaflet. Warnings: Spherox is an autologous medicinal product and must not be given to any other patient than the donor. Note: Available only on prescription. Pharmaceutical company: CO.DON AG, Warthestr. 21, D-14513 Teltow, Germany. Status: May 2021
SMPC
Summary of product characteristics for Spherox
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