Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarts & The London NHS Trust
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is older than 18 years of age
Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy
Must have attempted treatment with the maximally tolerated dose of at least two of the four approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for greater than 2 months prior to enrolment, with no intent to change the medical regimen for at least 12 months after randomisation
Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable or high risk for revascularization
Disqualifiers
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 days prior to enrolment
The predominant manifestation of angina is dyspnoea
Trial design
Design model
Parallel
Treatments tested in this trial
Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells.
Biological/VaccineBone 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).
Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath).
Procedure/SurgeryThese 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).
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Treatment armExperimental treatment 1 intervention
Group B: Sham armSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
To compare the effect of an intracoronary administration of autologous bone marrow-derived cells to a placebo sham treatment on Canadian Cardiovascular Society (CCS) angina scores in patients with refractory angina.
The change in Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.
Time frame
Measured pre procedure (baseline) and at 6 months post procedureSecondary outcomes
1
To compare the safety of an intracoronary administration of autologous bone marrow derived cells versus sham as measured by adverse events
Count of number of adverse events occuring in all participants
Time frame
Measured at 1 week post procedure, 6 months post procedure and 1 year post procedure2
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on myocardial ischaemic burden as measured by clinically indicated perfusion imaging
The change in myocardial ischaemia as measured by perfusion imaging in all participants
Time frame
Measured pre procedure (baseline) and at 6 months post procedure3
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on quality of life as measured by EQ-5D
The change in EQ-5D scores in all participants. Where the higher calculated score indicates a positive outcome.
Time frame
Measured pre procedure (baseline) and at 6 months post procedure and 1 year post procedure4
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on quality of life as measured by Seattle Angina Questionnaire (SAQ)
The change in SAQ scores in all participants. Where the higher calculated score indicates a positive outcome.
Time frame
Measured pre procedure (baseline) and at 6 months post procedure and 1 year post procedureSponsors and contacts
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Source ClinicalTrials.gov