REVIVE trial: Retrograde delivery of autologous bone marrow in patients with heart failure

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 ischemicBMACgroup and 6 to the ischemic control group. Similarly, 24 subjectswere randomized to the nonischemicBMACgroup 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 receivingBMACdemonstrated 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 thenonischemicBMACgroup from 55.6 to 50.9mm (p = .020). RetrogradeBMAC delivery is safe. All patients receivingBMAC experienced improvements in left ventricular ejection fraction, butonly those with NIHFshowed improvements in left ventricular endsystolic diameter and B-type natriuretic peptide. These results provide the basis for a larger clinical trial in HF patients.