NCT05711849

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Barts & The London NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Refractory Angina Pectoris
• Refractory Angina

Interventions

Type	Name	Description
BIOLOGICAL	Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells.	Bone marrow will be harvested from the posterior superior iliac crest under local anaesthetic, and mononuclear cells will be separated using a Ficoll technique in a certified laboratory. Later that same day, the participant will undergo an intracoronary cell infusion of the mononuclear cells. Participants will be blinded to their treatment arm (they will wear a blindfold and noise cancelling headphones for the bone marrow aspiration and cell infusion).
PROCEDURE	Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath).	These participants will have a sham bone marrow aspiration (a 3mm incision in the skin under local anaesthetic) and a sham intracoronary infusion procedure (the insertion of radial or femoral sheath under local anaesthetic). Participants will be blinded to their treatment arm (they will wear a blindfold and noise cancelling headphones for the sham bone marrow aspiration and sham cell infusion).

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2023-02-03
• Last updated: 2026-01-07

Locations

1 site across 1 country: United Kingdom