Phenotype of autologous cells in non-union fractures (PACINO)

• Research type

  Research Study

• Full title

  Autologous cell therapy of fracture non-union – cell phenotype as a predictor of outcome

• IRAS ID

  19442

• Contact name

  David Russell Marsh

• Sponsor organisation

  Universtiy College London

• Eudract number

  2010-019380-11

• ISRCTN Number

  ISRCTN09755245

• Research summary

  This study is about using patients?? own stem cells to help them heal defects in their bones - usually the consequence of fractures sustained in high energy accidents. The particular group we will study are those receiving treatment by the Ilizarov technique, where missing bone is regenerated by gradually stretching a cut in the bone using an external frame (bone transport). This technique is powerful, resolving otherwise intractable problems of bone loss, but patients consistently say they would value a reduction in the time they need to spend in the frame. One of the rate-limiting steps is healing of the site where the two bone ends meet. We currently try to speed this up by drilling across it and injecting bone marrow. We will test whether we achieve better stimulation by first culturing the stem cells from the bone marrow and injecting them in large numbers. We will measure the result using CT scans, which can quantify bone formation. However we will also study the variation between stem cells from different patients and try to identify features that lead to more vigorous bone formation. This will provide guidance as to how we should develop the protocols used in the culture process, to optimise the cells before use. The answers to these questions will be useful to patients undergoing bone transport, but they will also have implications for other patients with bone defects or fractures that will not heal.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  10/H0706/30

• Date of REC Opinion

  24 May 2010

• REC opinion

  Further Information Favourable Opinion