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Refractory Angina clinical trials

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NCT ID: NCT05711849 Not yet recruiting - Refractory Angina Clinical Trials

Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina

RegenCobra
Start date: September 1, 2023
Phase: Phase 2
Study type: Interventional

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.