Barts & The London NHS Trust
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.
Refractory Angina Pectoris
Refractory Angina
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).
Phase 2
REGENERATE-COBRA is a single centre, randomised (1:1) sham-controlled clinical trial taking place at St Bartholomew's Hospital in London, UK. It is recruiting 110 symptomatic refractory angina patients. All participants will be blinded to their treatment arm. They will wear a blindfold and noise cancelling headphones for the bone marrow aspiration and the infusion procedures. Patients allocated to the treatment arm will undergo a bone marrow aspiration. After cell processing, the autologous bone marrow-derived mononuclear cells are infused into the coronary arteries using the stop-flow technique. Patients allocated to the sham arm will undergo a sham bone marrow aspiration (a 3mm nick in the skin under local anaesthetic) and a sham cell infusion (a radial or femoral sheath will be inserted under local anaesthetic). All patients will be followed up with a phone call at 1 month and 12 months, and a clinic visit at 6 months. The primary endpoint is change in Canadian Cardiovascular Society (CCS) angina score at 6 months.}}
Study Type : | Interventional |
Estimated Enrollment : | 110 participants |
Masking : | Double |
Primary Purpose : | Treatment |
Official Title : | A Phase II Randomised Sham-controlled Trial Assessing the Safety and Efficacy of Intracoronary Administration of Autologous Bone Marrow Cells in Patients With Refractory Angina |
Actual Study Start Date : | September 1, 2023 |
Estimated Primary Completion Date : | August 31, 2025 |
Estimated Study Completion Date : | February 28, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment arm 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 Comparator: Sham arm 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). |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Not yet recruiting
St Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE