At a glance
ClinicalIndex Comparison Record- ✓Age older than 18 years
- ✓CCS Grade III or IV angina for ≥90 days despite maximal medical therapy
- ✓Maximally tolerated doses of ≥2 of 4 anti-anginal drug classes with stable regimen ≥2 months
- ✓No suitable options for CABG or PCI, or high-risk for revascularization
- ✕Recent (≤30 days) troponin or CKMB positive ACS (NSTEMI/STEMI)
- ✕Successful revascularization by CABG or PCI within 6 months
- ✕Unsuccessful PCI within 30 days
- ✕Predominant angina manifestation is dyspnoea
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells. and Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath). for Refractory Angina Pectoris and Refractory Angina. Currently recruiting, targeting 110 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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).
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).