ChondroCelect

What is ChondroCelect?

ChondroCelect is a suspension for implantation that contains cartilage cells.

ChondroCelect 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.

What is ChondroCelect used for?

ChondroCelect is used to repair damage to the cartilage of the knee in adults. It is indicated for the treatment of single symptomatic lesions in the cartilage of the femoral condyle (the lower end of the femur).

The medicine can only be obtained with a prescription .

How is ChondroCelect used?

ChondroCelect is a medicine that is prepared specifically for each patient and can only be used to treat the particular person for whom it was prepared.

ChondroCelect should be administered in a hospital setting by a qualified surgeon. First, a biopsy (a small sample) is taken from the patient's knee cartilage. Cartilage cells are then grown and expanded in the laboratory in order to obtain a sufficient quantity to constitute a cell suspension that can be used to treat cartilage lesion. During knee surgery, the suspension is implanted at the site of the patient's cartilage lesion. To maintain the cells in situ during cartilage repair, a biological membrane is then used as a sealant.

Patients treated with ChondroCelect are included in a specific rehabilitation program, including physiotherapy. This facilitates the recovery of patients from the operation, as well as allowing sufficient time for cartilage cell implantation and knee healing. The program can last up to a year.

How does ChondroCelect work?

The cartilage of the knee may be damaged due to an accident, such as a fall, or wear. The active substance in ChondroCelect is made up of the cartilage cells of the patient himself. These are "vital autologous cartilage cells characterized ex vivo expanded and expressing marker proteins

specific ", ie cells taken from the patient, made to grow outside the body and usable for implantation in the patient's cartilage. These cells repair the cartilage lesions by filling the space where it has been damaged.

How has ChondroCelect been studied?

The effects of ChondroCelect were first analyzed in experimental models before being studied in humans.

ChondroCelect was compared to the microfracture technique (a type of surgery used to treat cartilage lesions) in a main study involving 118 adult patients with symptomatic knee cartilage lesions. The lesions were in charge of the femoral condyle and had dimensions between 1 and 5 cm2. The main measures of effectiveness were the degree of improvement of the lesions after one year and the variation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) of patients after one and three years of treatment. KOOS was measured based on the evaluation of patient severity of symptoms.

What benefit has ChondroCelect shown during the studies?

ChondroCelect was more effective than the microfracture technique in repairing cartilage lesions. Scans and examination of cartilage samples carried out one year later showed that patients treated with ChondroCelect had a greater degree of structural cartilage repair than subjects treated with microfracture. ChondroCelect was also as effective as microfracture in improving symptoms. There was no clear evidence of a difference in KOOS variation in patients treated with ChondroCelect and those treated with microfracture.

What is the risk associated with ChondroCelect?

The most common side effects (seen in more than 1 patient in 10) of ChondroCelect are arthralgia (joint pain), hypertrophy (overgrowth), cartilage, crackling (unusual pops), joint articulation and swelling. For the full list of all side effects reported with ChondroCelect, see the Package Leaflet.

ChondroCelect must not be used in people who may be hypersensitive (allergic) to any of the excipients or to bovine serum (cow's blood).

Why has ChondroCelect been approved?

Because ChondroCelect is an advanced therapy medicine, it has been evaluated by the Committee for Advanced Therapies (CAT).

Based on the CAT assessment, the CHMP decided that ChondroCelect's benefits are greater than its risks for the repair of single cartilage symptomatic lesions of the femoral condyle of the knee (Grade III or IV , International Cartilage Repair Society [ICRS ]) in adults. The CHMP therefore recommended the granting of a marketing authorization for ChondroCelect.

What measures are being taken to ensure the safe use of ChondroCelect?

The ChondroCelect manufacturing company will ensure that all surgeons and other healthcare professionals who handle and use ChondroCelect receive training material regarding the use of the product. The material intended for surgeons will include information on how to take the cartilage biopsy, perform the surgery and follow up the patients. The material for other healthcare professionals will include information on handling the biopsy taken and preparing ChondroCelect for implantation as well as patient follow-up and recommended physiotherapy planning. The manufacturing company will also conduct further studies to obtain more information on the safety and efficacy of ChondroCelect.