drugs

Spherox - Spheroids of autologous chondrocytes associated with human matrix

What is Spherox - Spheroids of autologous chondrocytes associated with human matrix and what is it used for?

Spherox is a medicine indicated for the repair of knee cartilage defects in adults who experience certain symptoms (such as pain and problems with moving the knee). It is used in cases where the affected area is not wider than 10 cm2.

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

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

How is Spherox used - spheroids of autologous chondrocytes associated with human matrix?

Spherox is available as a suspension for implantation in the knee joint. The medicine is specially prepared for each individual patient and should be administered by a qualified physician in a healthcare facility.

To prepare the medicine, a small sample is taken from the patient's knee cartilage using arthroscopy (a type of laparoscopy). Cartilage cells are then grown in the laboratory to prepare a suspension of chondrocyte spheroids. During arthroscopy, the medicine is placed in the damaged area of ​​the patient's cartilage. Chondrocyte spheroids attach to cartilage within 20 minutes. Patients treated with Spherox must follow a specific rehabilitation program, which includes physiotherapy, to allow the chondrocyte spheroids to fit into the cartilage defect.

The medicine can only be obtained with a prescription.

How does Spherox - Spheroids of autologous chondrocytes associated with human matrix?

The cartilage of the knee may be damaged due to an accident, such as a fall or injury from a sports activity. Spherox contains spheroids obtained from the patient's own cartilage cells. When they are implanted in the patient's cartilage, these spheroids attach to the area affected by the defect and produce new tissue, thus repairing knee damage

What benefit has Spherox - Spheroids of autologous chondrocytes associated with human matrix shown during the studies?

Spherox has been shown to relieve patients' symptoms and improve knee function in two studies conducted on adults aged 18 to 50 years. The main efficacy parameter was the KOOS (Knee Injury and Osteoarthritis Outcome Score), which is classified on a scale from 0 to 100 (where 0 indicates the most serious symptoms and 100 indicates no symptoms). The KOOS was autocalcolato by patients who assessed the severity of their symptoms such as pain, impact on daily life, recreational and sports activities and quality of life.

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

The second study examined 73 patients with large cartilage defects of the knee, 4 to 10 cm². All these patients underwent treatment with Spherox, as microfracture is not recommended for repairing large defects. In this study, the results of Spherox patients improved by 16 points in the first year and further improvements were observed up to three years after treatment.

What are the risks associated with Spherox - Spheroids of autologous chondrocytes associated with human matrix?

The most common side effects with Spherox (seen in more than 1 patient in 10) are arthralgia (joint pain) and joint effusion (accumulation of fluid 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 should not be used in patients with generalized primary osteoarthritis or advanced knee osteoarthritis (conditions that cause 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.

Why has Spherox - Spheroids of autologous chondrocytes associated with human matrix been approved?

It has been shown that Spherox is effective in the treatment of knee cartilage defects ranging in size from 1 to 10 cm2.

The use of chondrocyte spheroids that attach to the cartilage of the knee allows less invasive surgery (arthroscopy). The safety profile was considered acceptable; expected side effects may be due for the most part to surgery.

The European Medicines Agency therefore decided that Spherox's benefits are greater than its risks and recommended that it be given marketing authorization. However, information on its long-term effects is still awaited.

What measures are being taken to ensure the safe and effective use of Spherox - Spheroids of autologous chondrocytes associated with human matrix?

The company that markets Spherox will ensure that all surgeons and other healthcare professionals who handle or use the medicine receive training materials on how to use and store them. Training materials for surgeons will include information on how to take the cartilage sample, perform the surgery and follow up the patients. Materials for use by other healthcare professionals will include information on screening, sample handling and preparation of Spherox for implantation, as well as patient follow-up and recommended physiotherapy planning.

The company will also continue the first study to obtain more information on Spherox's safety and long-term efficacy. In addition, two further studies will be conducted on the Spherox implementation, which will examine, among other things, the consistency of the finished product.

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

Other information on Spherox - Spheroids of autologous chondrocytes associated with human matrix

For the full version of the EPAR and the summary of the Spherox risk management plan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Spherox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.