REpeated AutoLogous Infusions of STem cells In Cirrhosis (REALISTIC)

• Research type

  Research Study

• Full title

  A MULTICENTRE, PHASE II, OPEN LABEL, RANDOMISED CONTROLLED TRIAL OF REPEATED AUTOLOGOUS INFUSIONS OF G-CSF MOBILISED CD133+ BONE MARROW STEM CELLS IN PATIENTS WITH CIRRHOSIS

• IRAS ID

  16745

• Sponsor organisation

  University Hospital Birmingham NHS Foundation Trust

• Eudract number

  2009-010335-41

• ISRCTN Number

  awaited

• Research summary

  In the UK liver disease is the fifth most common cause of mortality, and its incidence is rising dramatically. Effective treatments such as liver transplantation are already insufficient to meet clinical need.Adult Stem Cells are found in a variety of tissues in the body but principally the bone marrow. They are basic, immature cells which act as a repair and replacement system for the body. Certain types of stem cell have been found to help injured liver by reducing scarring and replacing damaged liver cells. However, as these stem cells usually stay in the bone marrow, it has been suggested that they need to be released towards the injured liver.Giving a medication called GCSF releases stem cells into the bloodstream in large numbers. This technique is routinely used in patients with blood disorders, and small studies have shown that it is safe to perform this procedure in patients with liver disease. However, not enough patients have been treated in this way to be able to tell whether there is a significant overall improvement in their liver function. Furthermore, it would be preferable to collect and purify the stem cells that have been released from the bone marrow into the bloodstream so that they can be administered whenever needed.This study will compare the effect of two treatments in patients with liver cirrhosis: (i) GCSF alone and (ii) GCSF followed by three infusions of collected and purified stem cells.The effect of these treatments on liver function at 3,6 and 12 months will be compared with a group of patients who have received only the standard treatment for patients with liver disease. The study will include enough patients to tell whether any improvement is due to the treatment rather than chance alone.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/64

• Date of REC Opinion

  30 Jun 2009

• REC opinion

  Further Information Favourable Opinion