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document
REVIVE Trial : Retrograde Delivery of Autologous Bone Marrow in Patients With Heart Failure . UNLABELLED Cell therapy is an evolving option for patients with end-stage heart failure and ongoing symptoms despite optimal medical therapy . Our goal was to evaluate retrograde bone marrow cell delivery in patients with either ischemic heart failure ( IHF ) or nonischemic heart failure ( NIHF ) . This was a prospective randomized , multicenter , open-label study of the safety and feasibility of bone marrow aspirate concentrate ( BMAC ) infused retrograde into the coronary sinus . Sixty patients were stratified by IHF and NIHF and randomized to receive either BMAC infusion or control ( standard heart failure care ) in a 4:1 ratio . Accordingly , 24 subjects were randomized to the ischemic BMAC group and 6 to the ischemic control group . Similarly , 24 subjects were randomized to the nonischemic BMAC group and 6 to the nonischemic control group . All 60 patients were successfully enrolled in the study . The treatment groups received BMAC infusion without complications . The left ventricular ejection fraction in the patients receiving BMAC demonstrated significant improvement compared with baseline , from 25.1 % at screening to 31.1 % at 12 months ( p=.007 ) in the NIHF group and from 26.3 % to 31.1 % in the IHF group ( p=.035 ) . The end-systolic diameter decreased significantly in the nonischemic BMAC group from 55.6 to 50.9 mm ( p=.020 ) . Retrograde BMAC delivery is safe . All patients receiving BMAC experienced improvements in left ventricular ejection fraction , but only those with NIHF showed improvements in left ventricular end-systolic diameter and B-type natriuretic peptide . These results provide the basis for a larger clinical trial in HF patients . SIGNIFICANCE This work is the first prospective randomized clinical trial using high-dose cell therapy delivered via a retrograde coronary sinus infusion in patients with heart failure . This was a multinational , multicenter study , and it is novel , translatable , and scalable . On the basis of this trial and the safety of retrograde coronary sinus infusion , there are three other trials under way using this route of delivery .
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Intervention_Physical
Cell therapy
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Intervention_Physical
bone marrow aspirate concentrate
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Intervention_Pharmacological
retrograde
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Intervention_Physical
BMAC infusion
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Intervention_Control
control
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Intervention_Physical
BMAC infusion
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Intervention_Physical
BMAC
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Outcome_Physical
left ventricular ejection fraction
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Outcome_Other
significant improvement
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Outcome_Physical
end-systolic diameter decreased significantly
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Outcome_Other
delivery is safe .
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Outcome_Physical
left ventricular ejection fraction
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Outcome_Physical
left ventricular end-systolic diameter and B-type natriuretic peptide .