REGENERATE-DCM

• Research type

  Research Study

• Full title

  Randomised Controlled Trial To Compare The effects of G-CSF(Granocyte™) And Autologous Bone Marrow Progenitor Cells On Quality Of Life And Left Ventricular Function In Patients with Idiopathic Dilated Cardiomyopathy

• IRAS ID

  3869

• Contact name

  Anthony Mathur

• Sponsor organisation

  Barts & the London NHS Trust

• Eudract number

  2009-013112-12

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The aim of the study is to determine if patients own bone marrow derived stem cells can be used to improve the function of the heart in patients with Idiopathic Dilated Cardiomyopathy (DCM - an enlargement of the heart) due to an unknown cause (Idiopathic DCM). Patients will be randomised to receiving (1)G-CSF (Granocytâ„¢ Chugai Pharm International), a hormone injection, for 5 days to stimulate the production of bone marrow or placebo injections.(2) G-CSF (Granocytâ„¢) for 5 days and then intracoronary injection (into the coronary arteries)of either placebo or stem cells at The London Chest Hospital. Pre-trial assessment & follow-up (at 3 & 12 months) appointments will be at, the London Chest, Royal Brompton or The Heart Hospital. Patients with an NHS number will be recruited from the United Kingdom. The research is funded by donations to the Heart Cells Foundation & Barts and The London Charity Foundation.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/10

• Date of REC Opinion

  7 Apr 2010

• REC opinion

  Further Information Favourable Opinion