EXCELLENT - version 5 dated 28th April 2015

• Research type

  Research Study

• Full title

  A multicentric controlled phase I / IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process, and injected in patients with an acute myocardial infarction and a LVEF remaining below or equal to 45% after PTCA and stent(s) implantation versus standard of care.

• IRAS ID

  157632

• Contact name

  David Newby

• Contact email

  d.e.newby@ed.ac.uk

• Sponsor organisation

  CellProthera S.A.S

• Eudract number

  2014-001476-63

• Clinicaltrials.gov Identifier

  VHP590 (VHP2014137), VHP (Voluntary Harmonisation Procedure for the assessment of multinational clinical trials in Europe)number

• Duration of Study in the UK

  1 years, 5 months, 28 days

• Research summary

  This phase I/IIb study is a multicentric, randomized, open-label, parallel group, in adults with acute myocardial infarction and reduced cardiac function who have undergone a coronary angioplasty and stent implantation, who will receive stem cells (peripheral blood CD34+) injections into the area of the heart damaged versus standard of care. In the stem cell injection arm (Verum arm), the stem cells will be derived from the peripheral blood sample of the patient. The cells will be cultured in an automated device (StemXpand device). The CD34+ stem cells graft (ProtheraCytes®) will be prepared and released from our Cell Therapy Center.

  The purpose of the phase I/IIB trial is to establish the safety profile of the intramyocardial CD34+ cell injection through the processes of cell harvest using Granulocyte Colony-Stimulating Factor (a growth factor) and injection using a specialised catheter inserted through the artery in the leg. We will study this technique in patients who have suffered an acute myocardial infarction (AMI, otherwise known as a heart attack), comparing them with a standard care group in AMI patients with a left ventricular ejection fraction (LVEF, a measure of the heart's pumping function) of 45% or less after angioplasty and stent(s) implantation.

  The primary endpoint is to assess the major adverse cardiac events, serious adverse events, and adverse events.
  The secondary endpoints are the improvement of the left ventricle and systolic volume index evaluated by the Cardiac Magnetic Resonance Imaging and the viability assesment of infarcted segments measured by the Single Positron Emission Computed Tomography (SPECT scan).

  The study will start in September 2015.
  The recruitment total duration is of 12 months.
  Each patient will be followed for 6 months after treatment.
  The study total study duration will then be 18 months.
  Estimation of 52 patients enrolled

• REC name

  Scotland B REC

• REC reference

  15/SS/0106

• Date of REC Opinion

  5 Aug 2015

• REC opinion

  Further Information Favourable Opinion