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

Refractory Angina Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Angina Pectoris
• Refractory Angina
• Refractory Angina Pectoris

• NCT number: NCT05711849
• Study type: Interventional
• Source: Barts & The London NHS Trust
• Contact: Stem Cell Research Team
• Phone: 0203 765 8704
• Email: bhnt.stemcells@nhs.net
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2024
• Completion date: February 28, 2026