Assessing the Safety & Effectiveness of Intracoronary Stem Cells in

Status Not yet 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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	Not yet recruiting
Phase	Phase 2
Start date	September 1, 2023
Completion date	February 28, 2026

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See also
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Recruiting	`NCT05102019` - Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II	N/A
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Recruiting	`NCT01566175` - Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Ngina Class 3-4 Who Are Not Candidates for Revascularization	N/A
Recruiting	`NCT05492110` - Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms