A Phase 2 interventional study of Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells. and Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath). in Refractory Angina Pectoris and Refractory Angina, sponsored by Barts & The London NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Barts & The London NHS Trust · Phase 2, Interventional, and Treatment
REGENERATE-COBRA will examine whether autologous stem cell treatment can improve angina symptoms and quality of life for patients with refractory angina. Patients will be randomised (randomly allocated with a 50:50 chance) to either the 'treatment' or the 'sham' group - they will not know which group they are in.
In the 'treatment' group:
In the 'sham' group:
REGENERATE-COBRA is a single centre, randomised (1:1) sham-controlled clinical trial taking place at St Bartholomew's Hospital in London, UK.
453 studies on the registry are indexed under Angina Pectoris; 67 are open to participants now.
This study's planned enrollment of 110 is close to the median of 100 across 273 interventional studies indexed under Angina Pectoris.
Browse Angina Pectoris studies →Barts & The London NHS Trust is the lead sponsor of 151 studies on the registry; 21 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells.
Biological: Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells.
Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath).
Procedure: Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath).
Bone marrow will be harvested from the posterior superior iliac crest under local anaesthetic, and mononuclear cells will be separated using a Ficoll technique in a certified laboratory. Later that same day, the participant will undergo an intracoronary cell infusion of the mononuclear cells. Participants will be blinded to their treatment arm (they will wear a blindfold and noise cancelling headphones for the bone marrow aspiration and cell infusion).
These participants will have a sham bone marrow aspiration (a 3mm incision in the skin under local anaesthetic) and a sham intracoronary infusion procedure (the insertion of radial or femoral sheath under local anaesthetic). Participants will be blinded to their treatment arm (they will wear a blindfold and noise cancelling headphones for the sham bone marrow aspiration and sham cell infusion).
To compare the effect of an intracoronary administration of autologous bone marrow-derived cells to a placebo sham treatment on Canadian Cardiovascular Society (CCS) angina scores in patients with refractory angina.
The change in Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.
Time frame: Measured pre procedure (baseline) and at 6 months post procedure
To compare the safety of an intracoronary administration of autologous bone marrow derived cells versus sham as measured by adverse events
Count of number of adverse events occuring in all participants
Time frame: Measured at 1 week post procedure, 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on myocardial ischaemic burden as measured by clinically indicated perfusion imaging
The change in myocardial ischaemia as measured by perfusion imaging in all participants
Time frame: Measured pre procedure (baseline) and at 6 months post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on quality of life as measured by EQ-5D
The change in EQ-5D scores in all participants. Where the higher calculated score indicates a positive outcome.
Time frame: Measured pre procedure (baseline) and at 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on quality of life as measured by Seattle Angina Questionnaire (SAQ)
The change in SAQ scores in all participants. Where the higher calculated score indicates a positive outcome.
Time frame: Measured pre procedure (baseline) and at 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on total exercise time as measured by a modified Bruce protocol exercise treadmill test
The change in total exercise time obtained by modified Bruce protocol in all participants
Time frame: Measured pre procedure (baseline) and at 6 months post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham as measured by angina frequency
The change in number of episodes of angina occuring in a four week period prior to baseline, 6 months and 1 year visit in all participants
Time frame: Measured pre procedure (baseline) and at 6 months post procedure and 1 year post procedure
To compare the safety of an intracoronary administration of autologous bone marrow- derived cells versus sham as measured by major adverse cardiovascular events (MACE; defined as non-fatal stroke, non-fatal myocardial infarction and cardiovascular death)
The number of major adverse events to occur measured at 6 months and 1 year in all participants
Time frame: Measured at 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham as measured by change in Canadian Cardiovascular Society angina score
The change in the Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.
Time frame: Measured at 6 months post procedure and 1 year post procedure
Plan to share: No
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