REGENERATE-COBRA
Research type
Research Study
Full title
A PHASE II RANDOMISED SHAM-CONTROLLED TRIAL ASSESSING THE SAFETY AND EFFICACY OF INTRACORONARY ADMINISTRATION OF AUTOLOGOUS BONE MARROW CELLS IN PATIENTS WITH REFRACTORY ANGINA
IRAS ID
1005427
Contact name
Anthony Mathur
Contact email
Sponsor organisation
Barts Health NHS Trust
Eudract number
2022-001047-24
Research summary
Due to improvements in medical therapies and revascularisation strategies, more people with coronary artery disease are surviving but living with chronic debilitating symptoms called Refractory angina (RFA). The management of angina remains challenging using conventional treatment strategies; a significant number of patients remain symptomatic despite PCI, CABG and anti-anginal drugs. In the UK, the management of patients with RFA is underprovided. The national provision of specialist care is limited with major geographical inequality in access to dedicated RFA services. Patients commonly end up in a perpetual and frequent cycle of long-term local review alternating between the outpatient and the A&E department and poses an economic burden. In this trial, we will investigate whether cell therapy will improve the blood flow to the heart and relieve the symptoms of angina. The cells harvested from patients’ own bone marrow are not yet ‘specialised’ and so have the potential to become any type of cell. These stem cells are infused into the heart arteries with the aim of improving the heart’s blood supply and the symptoms of refractory angina. 110 patients will be recruited over 18 months. Half of the patients will have cell therapy whilst the other half will undergo a sham procedure. All patients will be treated at Barts Heart Centre and will be followed up at 1 week, 6months and 12 months after their treatment. Patients will not be aware of what treatment they have received until after the study has been completed.
Eligible patients will undergo a screening visit to confirm they meet all inclusion criteria and collect baseline angina score, quality of life, total exercise time and myocardial perfusion information. This assessment will be repeated at 6 and 12 months to assess whether the cell therapy leads to an improvement in angina symptoms and quality of life.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0040
Date of REC Opinion
22 Sep 2023
REC opinion
Further Information Favourable Opinion