Autologous Stem Cells, Chondrocytes or the Two? (ASCOT)

• Research type

  Research Study

• Full 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.

• IRAS ID

  50345

• Eudract number

  2010-022072-31

• ISRCTN Number

  ISRCTN98997175

• Clinicaltrials.gov Identifier

  50345, IRAS Project Code

• Duration of Study in the UK

  7 years, 9 months, 1 days

• Research summary

  Osteoarthritis is a major debilitating condition affecting the bone and cartilage of articular joints. Symptoms include joint damage, pain and loss of mobility. In the longer term, most patients with osteoarthritis need a total joint replacement.

  Cell therapy is a novel method of treating patients with damaged cartilage and bone, but it is not yet known which type of cells would do this best. In Oswestry, patients with localised cartilage damage have been treated with cartilage cells (chondrocytes) for over 10 years and patients with bone fractures that fail to heal properly are treated with bone marrow-derived stem cells. In all, over 400 patients to date have been treated with their own cells for cartilage and / or bone repair.

  These patients are treated with cells that have been grown in specialist facilities available on the hospital site from small samples of their own cartilage or bone marrow. Since this technique uses the patients' own cells (called autologous), the cells are not likely to cause an immune response.

  We aim to see if stem cells from bone marrow will be able to repair the damage to joints better than cartilage cells, or if the two cell types are better when used in combination.

  The outcome measures will include assessments of safety and efficacy. The primary outcome will be patient-centred functional knee scores (Lysholm) with an initial analysis at 15 months as this has previously shown to be indicative of longer term outcome to 9 years. Eventually, we will determine whether cell therapies of this nature can be an effective treatment for patients with osteoarthritic joint damage and hence can delay or prevent the need for a total joint replacement.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  11/WM/0175

• Date of REC Opinion

  28 Jul 2011

• REC opinion

  Favourable Opinion