ASCOT Trial

Study Area:  Osteoarthritis of the knee

Study Title:  Autologous Stem Cells, Chondrocytes Or the Two? (ASCOT)

Location:  Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Oswestry, Shropshire.

Scientific Title: Autologous cell therapy for osteoarthritis: An evaluation of the safety and efficacy of autologous transplantation of articular chondrocytes and/or bone marrow-derived stromal cells to repair chondral/osteochondral lesions of the knee.

Information for patients


Background

Cell therapy is successfully used to repair damaged joint cartilage, but it is not yet known which type of cells would do this best. Patients in the UK with localised cartilage damage can be treated with cells (chondrocytes) grown from small samples of their own cartilage. This treatment has been successfully used for many years worldwide.  Similar procedures using stem cells instead of cartilage cells have been used in Japan.

Stem cells have the potential to develop into many different cell types that carry out different functions. The bone marrow contains a population of such cells known as bone marrow-derived stromal cells (BMSCs) which can develop into either bone or cartilage, and have the capacity to repair damaged or diseased tissues. 

The ASCOT trial aims to see if BMSCs will be able to repair the damage to joints better than cartilage cells, or if a combination of BMSCs and cartilage cells is better.

The study started in January 2014 and will be enrolling patients for approximately 3 years.  The study will be taking place at The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Oswestry, Shropshire.


How do I get more information?

Please click here for the Participant Information Leaflet.

You can also find more information on this study on the Current Controlled Trials website at: http://www.controlled-trials.com/ISRCTN98997175

If you would like more information about taking part in a clinical trial visit the NHS Clinical Trials Gateway website


Who can participate?

  1. You must have symptomatic cartilage damage or degeneration to your knee.
  2. You must be aged between 18 and 80 years at the time of surgery.
  3. Your surgeon must consider that your arthritis is suitable for treatment with cell therapy.
  4. You must be able to provide written informed consent to take part in the study.

You will not be able to take part in the study if any of the following apply:

  1. You do not adequately understand verbal explanations or written information given in English.
  2. You have been diagnosed with inflammatory arthritis, have a previous or current malignant tumour, you are being treated with steroids or methotrexate.
  3. You are unwilling or unable to complete the program of physiotherapy or the study follow-up.
  4. The area of damage to your cartilage is very large (greater than 20cm2).
  5. You have a positive blood test for any of the following:  HIV, hepatitis B and C, syphilis, or human T cell lymphotrophic virus (HTLV) I or II.
  6. You are pregnant or breastfeeding.

Autologous cell therapy is an extensive undertaking as two operations are needed followed by three months of intensive physiotherapy, and up to 12 months of restricted activities. Full benefit may not be felt until over a year after surgery.


How do I enrol?

If you feel that you wish to be considered for this trial it is essential that you make an appointment with your GP in order to get a referral to see your local orthopaedic surgeon, who can then make a recommendation as to the most suitable treatment for your knee. This may be cell therapy or a number of other options such as knee replacement.  If your surgeon thinks you may benefit from an autologous cell therapy to your knee then he or she can refer you to our surgeons at Oswestry. We will need to see your latest MRI and arthroscopic pictures.

You can refer your GP or Orthopaedic consultant to this website for more information; alternatively click here for a printable information leaflet for clinicians.


Information for Orthopaedic Surgeons

If you think your patient may benefit from autologous cell therapy to the knee then you are welcome to write and request an opinion from our team at Oswestry. We will need access to the most recent MRI and arthroscopic pictures.  MRIs can be transferred electronically by us if necessary.  Arthroscopic pictures can be sent by email to an NHS .net address, or copies can be posted.

Any referral should summarise the history including the duration of symptoms, the previous procedures and any mal-alignment or meniscectomy that may need to be addressed.

downloadable information sheet for clinicians is available here. (PDF)

Download the ASCOT Participant Pathway (PDF)