A trial of cardiac injections of iMP cells during CABG surgery (V1).
Research type
Research Study
Full title
A Phase IIB, Randomised, Double-Blinded, Placebo-Controlled Study of the Efficacy and Safety of Intramyocardial Injection of Allogeneic Human Immunomodulatory Progenitor (iMP) cells in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery.\n
IRAS ID
226737
Contact name
Ali Vazir
Contact email
Sponsor organisation
Cell Therapy Ltd (t/a Celixir)
Eudract number
2017-000516-42
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
This study is currently paused. Building on the results of an earlier investigation, the aim of this trial is to establish the extent to which injecting immunomodulatory progenitor (iMP) cells into heart muscle at the time of coronary artery bypass graft surgery improves heart muscle scar reversal and heart function compared to a control group that will receive a placebo injection during bypass surgery. In this trial, the intention is to have a test group and a control group so that direct comparisons can be made between the groups. The trial will take place in London (Royal Brompton and Harefield hospitals). Participants will be National Health Service (NHS) treated individuals who require coronary artery bypass graft surgery. Both male and female participants will be recruited, men aged 18 to 80, and to minimise the potential risks during pregnancy, women aged 55 to 80. Given the age of individuals undergoing bypass surgery, it is unlikely that there will be many male participants under the age of 40. The participants will receive one dose of cells (8 injections) or 8 control injections into the heart muscle during surgery. Participants will be monitored for 12 months after surgery and, in order to assess scar change, will receive before and after (6 months) magnetic resonance imaging (MRI) heart scans. From 12 months after surgery, participants will receive standard routine post surgery care only.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/0020
Date of REC Opinion
20 Mar 2018
REC opinion
Further Information Favourable Opinion