ChondroCelect

characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins

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About

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is ChondroCelect?

ChondroCelect is a suspension for implantation that contains cartilage cells.

ChondoCelect 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.

What is ChondroCelect used for?

ChondroCelect is used in adults to repair damage to the cartilage in the knee. It is used when there is a single defect in the cartilage of the femoral condyle (the bottom end of the thighbone) that is causing symptoms.

The medicine can only be obtained with a prescription.

How is ChondroCelect used?

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

ChondroCelect must be administered by a qualified surgeon in a hospital. First, a biopsy (a small sample) is taken from the patient’s cartilage in the knee. The cartilage cells are then grown and expanded in the laboratory to provide enough cells to make up a suspension of cells that can be used to treat the cartilage defect. During surgery on the knee, the suspension is placed into the defect in the patient’s cartilage. A biological membrane is then used as a seal to keep the cells in place while the cartilage repairs.

Patients treated with ChondroCelect should follow specific rehabilitation programme, including physiotherapy. This helps the patients to recover from the operation but also leaves enough time for the cartilage cells to implant themselves and for the knee to heal. The programme may last up to approximately a year.

How does ChondroCelect work?

Cartilage in the knee can be damaged because of an accident, such as a fall, or because they wear off. The active substance in ChondroCelect is the patient’s own cartilage cells. These cells are ‘characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins’. This means that they are cells taken from the patient, grown outside the body and can be used for implantation into the patient’s cartilage. . These cells repair the defects in the knee by producing new cartilage.

How has ChondroCelect been studied?

ChondroCelect was compared with microfracture (a type of surgery used to treat defects in cartilage) in one main study involving 118 adult patients with symptoms caused by defects in their knee cartilage. The defects were on the femoral condyle and were between 1 and 5 cm2 in size. The main measures of effectiveness were how well the defects had healed after one year and the change in the patients’ knee-injury and osteoarthritis outcome score (KOOS) after one and three years of treatment. The KOOS was measured by patients rating the severity of their symptoms.

What benefit has ChondroCelect shown during the studies?

ChondroCelect was more effective than microfracture at healing the defects in the cartilage. After one year, when scans were performed and samples of cartilage were examined, patients who were treated with ChondroCelect showed better structural repair of their cartilage than patients treated with microfracture. ChondroCelect was also as effective as microfracture at improving symptoms. There was no clear evidence of a difference in the change of KOOS in patients treated with ChondroCelect and those treated with microfracture.

What is the risk associated with ChondroCelect?

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

ChondroCelect must not be used in people who are hypersensitive (allergic) to any of the other ingredients or to bovine serum (cow’s blood). It must also not be used in patients with advanced osteoarthritis of the knee (a disease causing swelling and pain in the knee) and those with the femoral growth plate (the end part of the thighbone) that is not fully closed.

Why has ChondroCelect been approved?

Because ChondroCelect is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT). Based on the assessment performed by the CAT, the CHMP decided that ChondroCelect’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The CHMP considered that ChondroCelect was shown to be effective at treating defects in the knee cartilage between 1 and 5 cm2 in size, and that the safety profile was considered acceptable. However, knowledge on the long-term effect of the medicine is limited.

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

A risk management plan has been developed to ensure that ChondroCelect is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ChondroCelect, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that makes ChondroCelect will ensure that all surgeons and other healthcare professionals involved in the handling or use of ChondroCelect receive training materials on how to use the product. The training materials for surgeons will include information on how to collect the cartilage biopsy from patients, perform the operation and follow patients up. The materials for other healthcare professionals will include information on how to handle the collected biopsy and prepare ChondroCelect for implantation, and how to follow patients up and plan the recommended physiotherapy. The company is also performing an observational study to obtain more information about the safety and effectiveness of ChondroCelect.

Other information about ChondroCelect

The European Commission granted a marketing authorisation valid throughout the European Union for ChondroCelect on 5 October 2009.

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

Name Language First published Last updated
ChondroCelect : EPAR - Summary for the public BG = bălgarski 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public ES = español 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public CS = čeština 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public DA = dansk 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public DE = Deutsch 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public ET = eesti keel 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public EL = elliniká 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public EN = English 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public FR = français 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public IT = italiano 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public LV = latviešu valoda 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public LT = lietuvių kalba 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public HU = magyar 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public MT = Malti 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public NL = Nederlands 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public PL = polski 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public PT = português 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public RO = română 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public SK = slovenčina 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public SL = slovenščina 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public FI = suomi 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public SV = svenska 16/11/2009 10/09/2014
ChondroCelect : EPAR - Summary for the public HR = Hrvatski 16/11/2009 10/09/2014

This EPAR was last updated on 07/11/2014 .

Authorisation details

Product details

Product details for ChondroCelect
NameChondroCelect
Agency product numberEMEA/H/C/000878
Active substance

characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins

International non-proprietary name (INN) or common name

characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins

Therapeutic area Cartilage Diseases
Anatomical therapeutic chemical (ATC) code M09AX02

Publication details

Publication details for ChondroCelect
Marketing-authorisation holder

TiGenix N.V.

Revision6
Date of issue of marketing authorisation valid throughout the European Union05/10/2009

Contact address:

TiGenix N.V.
Romeinse straat 12/2
B-3001 Leuven
Belgium

Product information

Product information

14/10/2014  ChondroCelect -EMEA/H/C/000878 -IAIN/012/G

Name Language First published Last updated
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014
ChondroCelect : EPAR - Product Information HR = Hrvatski 16/11/2009 07/11/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 16/11/2009  

Name Language First published Last updated
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 16/11/2009  

Pharmacotherapeutic group

Other drugs for disorders of the musculo-skeletal system

Therapeutic indication

Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.

Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present. Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1 and 5 cm².

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
ChondroCelect : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 21/10/2011 07/11/2014

Initial marketing-authorisation documents

Name Language First published Last updated
ChondroCelect : EPAR - Public assessment report HR = Hrvatski 16/11/2009  
Committee for medicinal products for human use summary of positive opinion for ChondroCelect HR = Hrvatski 25/06/2009  

Authorised

This medicine is approved for use in the European Union