At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells. (biological), Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath). (procedure)
- How long the study runs
- Study runs about 29 months (dates as stated)
- About the drug or intervention
- Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells. — biological: 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. · Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath). — procedure: 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).
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 110
- Started
- 2024-03-01
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for refractory angina pectoris
- • Phase2 - 110 participants
- • REGENERATE-COBRA will examine whether autologous stem cell treatment can improve angina symptoms and quality of life for patients with refractory angina
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with refractory angina pectoris
Where?
- • London - St Bartholomew's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Subject is older than 18 years of age
- ✓Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous...
- ✓Evidence of either exercise or pharmacologically induced reversible ischemia severity by stress echo, nuclear study,...
- ✓Functional limitation due to refractory angina as defined by a modified Bruce exercise tolerance test duration of...
- ✓Subject is willing and able to sign agreement to take part
Who cannot take part
- ✗Recent (within 30 days prior to enrolment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI).
- ✗Recent successful revascularization by CABG or PCI within six months prior to enrolment
- ✗Recent unsuccessful PCI (e.g., no relief from symptoms, failed attempt to open a chronic total occlusion) within 30...
- ✗The predominant manifestation of angina is dyspnoea
- ✗NYHA Class III or IV heart failure (HF), decompensated HF or hospitalisation due to HF during the 90 days prior to...
See the full criteria
Where Is This Study? (1 UK site)
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
How to Get in Touch
Stem Cell Research Team
Sponsor contactCONTACT
Alice Reid
Sponsor contactCONTACT
