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Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina (RegenCobra)
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.
Details
| Lead sponsor | Barts & The London NHS Trust |
|---|---|
| Phase | PHASE2 |
| Status | RECRUITING |
| Enrolment | 110 |
| Start date | Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Aug 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Refractory Angina Pectoris
- Refractory Angina
Interventions
- 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).
Countries
United Kingdom