Actively Recruiting
Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina
Led by Barts & The London NHS Trust · Updated on 2026-01-07
110
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: * Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic (a bone marrow aspiration). * Under local anaesthetic, the stem cells will be infused into the arteries that supply blood to the heart through a small tube inserted either in the wrist or the groin. * The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months. In the 'sham' group: * A sham bone marrow aspiration is performed - a 3mm nick in the skin will be made under local anaesthetic. * A sham cell infusion is performed - a small tube is inserted either in the wrist or groin under local anaesthetic. * The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months.
CONDITIONS
Official Title
Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is older than 18 years of age
- Persistent refractory angina pectoris for 90 days or more classified as CCS Grade III or IV despite maximum tolerated medical therapy
- Tried stable doses of at least two of the following anti-anginal medications for over 2 months: long-acting nitrates, calcium channel blockers, beta blockers, or ranolazine
- No treatment options for revascularization by coronary artery bypass grafting or percutaneous coronary intervention, or unsuitable/high risk for revascularization
- Evidence of reversible ischemia by stress or imaging tests
- Functional limitation with exercise tolerance test duration between 2 and 8 minutes
- Left ventricular ejection fraction greater than or equal to 30% within 12 months prior to procedure
- Willing and able to give informed consent
- Willing to comply with follow-up evaluations
You will not qualify if you...
- Acute coronary syndrome with positive troponin or CKMB within 30 days prior to enrolment
- Successful revascularization by CABG or PCI within 6 months prior to enrolment
- Unsuccessful PCI within 30 days prior to enrolment
- Predominant symptom of dyspnoea rather than angina
- Extra-coronary causes of angina such as untreated hyperthyroidism, anemia (hemoglobin <10 g/dL), uncontrolled hypertension, atrial fibrillation with rapid ventricular response, severe aortic stenosis, hypertrophic cardiomyopathy with obstruction
- NYHA Class III or IV heart failure or hospitalization for heart failure within 90 days
- Life threatening or future-defining rhythm disorders
- Severe COPD indicated by FEV1 less than 55% predicted or need for oxygen or steroids
- Severe valvular heart disease
- Moderate or severe right ventricular dysfunction
- Chronic severe renal failure (eGFR less than 30 mL/min/1.73m2)
- Conditions interfering with trial compliance such as active substance abuse or dementia
- Currently enrolled in other interfering investigational trials
- Pregnancy or planning pregnancy within 12 months
- Vulnerable populations unable to give informed consent
- Inability to tolerate dual antiplatelet therapy or P2Y12 inhibitor as required
- Comorbidities limiting life expectancy to less than one year
- Documented acute infection
- Use of immunosuppressive medication
- Inability to understand written and verbal English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Actively Recruiting
Research Team
S
Stem Cell Research Team
CONTACT
A
Alice Reid
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here