BOA response to media report regarding bone therapeutics

The Mail on Sunday published an article yesterday (1st February 2015) regarding the pioneering stem cell treatment which could avoid thousands of hip replacements. We are publishing a statement, to provide our members and their patients with a background to this and a BOA perspective.

Bone Therapeutics Authorised to Enrol Patients in the UK in Pivotal Phase III Osteonecrosis Trial

Avascular Necrosis of the bone happens when hip bone loses the blood supply to the femoral head (part of the thigh which forms the hip joint) and dies. This can happen anywhere in the body but most often occurs in the hip. The body will attempt to repair the damage but this is not always possible, in which case the structure of bone can be affected e.g. fracture and collapse.

Patients will generally experience pain and difficulty putting weight through the hip. If the problem is severe the resulting damage may require a joint replacement, which removes the affected area and replaces it with an implant. Over the last few decades research has been focused on surgical procedures to prevent and slow down the disease progression in order to preserve the patient’s own hip.

Cell therapy is one of the proposed methods of achieving tissue repair and regeneration and is described in other branches of orthopaedic surgery; cartilage cells (chondrocytes) the use of cartilage repair in osteoarthritis. Call therapy and Regenerative Medicine are an exciting future development within Orthopaedic Surgery – particularly if they can be added to and improve the outcomes of our current surgical procedures. However they can be expensive and as yet use in humans has been limited.

This exciting new patient study aims to be our best available treatment to date and will evaluate the effect of adding bone forming cells (osteoblasts) at the time of core decompression, in patients with early AVN of the hip. All patients will receive the current best treatment but patients will be randomly allocated to receive cells or not. 

This study can be seen as part of a complex pathway to carefully introduce new treatments to our patients by responsible translational research, also called bench to bedside research. We anticipate that the newly authorised randomised clinical trial will add to our clinical knowledge concerning the use of cell therapy in this important condition.