Spheroids of human autologous matrix-associated chondrocytes
Spheroids of human autologous matrix-associated chondrocytes, sold under the brand name Spherox, is a medication used to repair defects to the cartilage in the knee in adults who are experiencing knee pain and problems moving the knee.[1] It is used where the affected area is no larger than 10 cm2.[1]
| Clinical data | |
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| Trade names | Spherox |
| Other names | Spherox 10-70 spheroids/cm2 implantation suspension |
| Routes of administration | Intra-articular |
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The most common side effects include arthralgia (joint pain) and joint effusion (accumulation of liquid in the knee), which can cause swelling of the joint.[1]
Spherox contains spheroids (spherical aggregates) of chondrocytes, cells found in healthy cartilage, that have been prepared from the patient's own tissues.[1]
Medical uses
Spherox is indicated for the repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Repair Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults.[1][2]
To prepare the medicine, a small sample is taken by arthroscopy (a type of keyhole surgery) from the patient's cartilage in the knee.[1] The cartilage cells are then grown in the laboratory to prepare a suspension of chondrocyte spheroids.[1] During arthroscopy, the medicine is placed into the damaged area of the patient's cartilage.[1] The chondrocyte spheroids attach to the cartilage within 20 minutes.[1] People treated with Spherox should follow a specific rehabilitation program including physiotherapy.[1] This allows the chondrocyte spheroids to fill in the cartilage defect.[1]
History
Spherox has been shown to improve symptoms and knee function in two studies in adults between 18 and 50 years of age.[1] The main measure of effectiveness was the KOOS (knee injury and osteoarthritis outcome score), which is graded on a scale of 0 to 100 (where 0 means severest symptoms and 100 means no symptoms).[1] The KOOS was self-measured by participants rating the severity of their symptoms such as pain, impact on daily living, sport and recreational activities, and quality of life.[1]
In the first study involving 102 participants, Spherox was compared with microfracture (a type of surgery used to treat defects in cartilage).[1] The knee cartilage defects were between 1 and 4 cm2 in size.[1] Preliminary data from this study after one year show that Spherox improved the outcome score by 22 points and was as effective as microfracture.[1]
The second study looked at 73 participants with large cartilage defects of the knee from 4 to 10 cm2.[1] All these participants received treatment with Spherox, as microfracture is not recommended to repair large defects.[1] In this study, participants' outcome scores with Spherox improved by 16 points in the first year and further improvements were seen up to three years after treatment.[1]
References
- "Spherox EPAR". European Medicines Agency. Retrieved 29 June 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- "Spherox : EPAR - Product Information" (PDF). European Medicines Agency. Retrieved 29 June 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.