NCT05711849 Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina
| NCT ID | NCT05711849 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Barts & The London NHS Trust |
| Condition | Refractory Angina Pectoris |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-08-31 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Subject is older than 18 years of age 2. Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy 3. Must have attempted treatment with the maximally tolerated dose of at least two of the four approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for greater than 2 months prior to enrolment, with no intent to change the medical regimen for at least 12 months after randomisation 4. Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable or high risk for revascularization 5. Evidence of either exercise or pharmacologically induced reversible ischemia severi