Spherox

spheroids of human autologous matrix-associated chondrocytes

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This is a summary of the European public assessment report (EPAR) for Spherox. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Spherox.

For practical information about using Spherox, patients should read the package leaflet or contact their doctor or pharmacist.

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.

Name Language First published Last updated
Spherox : EPAR - Summary for the public BG = bălgarski 2017-07-24  
Spherox : EPAR - Summary for the public ES = español 2017-07-24  
Spherox : EPAR - Summary for the public CS = čeština 2017-07-24  
Spherox : EPAR - Summary for the public DA = dansk 2017-07-24  
Spherox : EPAR - Summary for the public DE = Deutsch 2017-07-24  
Spherox : EPAR - Summary for the public ET = eesti keel 2017-07-24  
Spherox : EPAR - Summary for the public EL = elliniká 2017-07-24  
Spherox : EPAR - Summary for the public EN = English 2017-07-24  
Spherox : EPAR - Summary for the public FR = français 2017-07-24  
Spherox : EPAR - Summary for the public IT = italiano 2017-07-24  
Spherox : EPAR - Summary for the public LV = latviešu valoda 2017-07-24  
Spherox : EPAR - Summary for the public LT = lietuvių kalba 2017-07-24  
Spherox : EPAR - Summary for the public HU = magyar 2017-07-24  
Spherox : EPAR - Summary for the public MT = Malti 2017-07-24  
Spherox : EPAR - Summary for the public NL = Nederlands 2017-07-24  
Spherox : EPAR - Summary for the public PL = polski 2017-07-24  
Spherox : EPAR - Summary for the public PT = português 2017-07-24  
Spherox : EPAR - Summary for the public RO = română 2017-07-24  
Spherox : EPAR - Summary for the public SK = slovenčina 2017-07-24  
Spherox : EPAR - Summary for the public SL = slovenščina 2017-07-24  
Spherox : EPAR - Summary for the public FI = suomi 2017-07-24  
Spherox : EPAR - Summary for the public SV = svenska 2017-07-24  
Spherox : EPAR - Summary for the public HR = Hrvatski 2017-07-24  
Name Language First published Last updated
Spherox : EPAR - Risk-management-plan summary (English only) 2017-07-24  

This EPAR was last updated on 24/07/2017 .

Authorisation details

Product details

Product details for Spherox
NameSpherox
Agency product numberEMEA/H/C/002736
Active substance

spheroids of human autologous matrix-associated chondrocytes

International non-proprietary name (INN) or common name

spheroids of human autologous matrix-associated chondrocytes

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

Publication details

Publication details for Spherox
Marketing-authorisation holder

CO.DON AG

Revision0
Date of issue of marketing authorisation valid throughout the European Union10/07/2017

Contact address:

CO.DON AG
Warthestr. 21 
14513 Teltow 
Germany

Product information

Product information

10/07/2017  Spherox -EMEA/H/C/002736

Name Language First published Last updated
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  
Spherox : EPAR - Product Information EN = English 2017-07-24  

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
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  
Spherox : EPAR - All Authorised presentations EN = English 2017-07-24  

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Spherox : EPAR - Public assessment report EN = English 2017-07-24  
CHMP summary of positive opinion for Spherox EN = English 2017-05-19