Skip to Content

Spherox

Active Substance: spheroids of human autologous matrix-associated chondrocytes
Common Name: spheroids of human autologous matrix-associated chondrocytes
ATC Code: M09AX02
Marketing Authorisation Holder: CO.DON AG
Active Substance: spheroids of human autologous matrix-associated chondrocytes
Status: Authorised
Authorisation Date: 2017-07-10
Therapeutic Area: Cartilage Diseases
Pharmacotherapeutic Group: Other drugs for disorders of the musculo-skeletal system

Therapeutic Indication

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.

What is Spherox and what is it used for?

Spherox is a medicine used to repair defects to the cartilage in the knee in adults who are experiencing symptoms (such as pain and problems moving the knee). It is used where the affected area is no larger than 10 cm².

Spherox is a type of advanced therapy medicine called a ‘tissue engineered product’. This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate or replace tissue.

Spherox contains spheroids (spherical aggregates) of chondrocytes, cells found in healthy cartilage.

How is Spherox used?

Spherox is available as a suspension for implantation into the knee joint. The medicine is prepared specifically for each individual patient and must be given by a qualified doctor in a medical facility.

To prepare the medicine, a small sample is taken by arthroscopy (a type of keyhole surgery) from the patient’s cartilage in the knee. The cartilage cells are then grown in the laboratory to prepare a suspension of chondrocyte spheroids. During arthroscopy, the medicine is placed into the damaged area of the patient’s cartilage. The chondrocyte spheroids attach to the cartilage within 20 minutes.

Patients treated with Spherox should follow a specific rehabilitation programme, including physiotherapy. This allows the chondrocyte spheroids to fill in the cartilage defect.

The medicine can only be obtained with a prescription.

How does Spherox work?

Cartilage in the knee can be damaged because of an accident, such as a fall or a sport injury. Spherox contains spheroids made from the patient’s own healthy cartilage cells. When the spheroids are implanted into the patient’s cartilage, they attach to the area of the defect and produce new tissue, thereby repairing the defects in the knee.

What benefits of Spherox have been shown in studies?

Spherox has been shown to improve patients’ symptoms and knee function in two studies in adults between 18 and 50 years of age. 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). The KOOS was self-measured by patients rating the severity of their symptoms such as pain, impact on daily living, sport and recreational activities, and quality of life.

In the first study involving 102 patients, Spherox was compared with microfracture (a type of surgery used to treat defects in cartilage). The knee cartilage defects were between 1 and 4 cm2 in size. Preliminary data from this study after one year show that Spherox improved by 22 points the outcome score and was as effective as microfracture.

The second study looked at 73 patients with large cartilage defects of the knee from 4 to 10 cm². All these patients received treatment with Spherox, as microfracture is not recommended to repair large defects. In this study, patients’ outcome scores with Spherox improved by 16 points in the first year and further improvements were seen up to three years after treatment.

What are the risks associated with Spherox?

The most common side effects with Spherox (seen in more than 1 patient in 10) are arthralgia (joint pain) and joint effusion (accumulation of liquid in the knee), which can cause swelling of the joint. For the full list of all side effects reported with Spherox, see the package leaflet.

Spherox must not be used in patients with primary generalised osteoarthritis or with advanced osteoarthritis of the knee (conditions causing swelling and pain in the joints) and in patients whose bones in the knee joint are still growing. It must also not be used in patients infected with hepatitis B, C and/or HIV virus.

Why is Spherox approved?

Spherox has been shown to be effective at treating defects in the knee cartilage between 1 and 10 cm2 in size. Using chondrocyte spheroids that attach to the knee cartilage allows for a less invasive surgery (i.e. arthroscopy). The safety profile was considered acceptable; most side effects expected can be due to the surgery. The European Medicines Agency therefore decided that Spherox’s benefits are greater than its risks and recommended that it be given marketing authorisation. However, knowledge on the long-term effects of the medicine is still awaited.

What measures are being taken to ensure the safe and effective use of Spherox?

The company that markets Spherox will ensure that all surgeons and other healthcare professionals handling or using the medicine receive training materials on how to use and store it. The training materials for surgeons will include information on how to collect the cartilage sample from patients, perform the operation and follow up their patients. The materials for other healthcare professionals will include information on how to screen and handle the collected sample and prepare Spherox for implantation, and how to follow patients up and plan the recommended physiotherapy.

The company will also continue the first study to obtain more information about the long-term safety and effectiveness of Spherox. In addition, two other studies will be carried out on the manufacture of Spherox, which will look, among other things, at the consistency of the finished product.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spherox have also been included in the summary of product characteristics and the package leaflet.

Other information about Spherox

The European Commission granted a marketing authorisation valid throughout the European Union for Spherox on 10 July 2017.

For more information about treatment with Spherox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide