Citations 2
Autologous CD34+ cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials
Henry, Timothy D. , Losordo, Douglas W. , Schatz, Richard A. , Jolicoeur, E Marc, Schaer, Gary L. , Clare, Robert M., White, Christopher J. , Fortuin, F. David , Kereiakes, Dean J. , Zeiher, Andreas M. , Sherman, Warren, Hunt, Andrea S, Povsic, Thomas J. , Traverse, Jay H. , Jolicoeur, E Marc, Chiswell, Karen
European Heart Journal | December 14, 2017 | Volume: 39 | Issue: 23 | Pages: 2208-2216
Autologous CD34 + Cell Therapy for Refractory Angina: 2-Year Outcomes from the ACT34-CMI Study
Henry, Timothy D. , Schaer, Gary L. , Povsic, Thomas J. , Davidson, Charles J., Lee, Joon Sup, Bass, Theodore A., Mendelsohn, Farrell O., Fortuin, F. David , Pepine, Carl J. , Patel, Amit N. , Riedel, Norbert, Junge, Candice, Hunt, Andrea S, Kereiakes, Dean J. , Harrington, Robert A. , Schatz, Richard A. , Losordo, Douglas W. , Traverse, Jay H. , Costa, Marco Antonio , White, Christopher J.
Cell Transplantation | May 5, 2016 | Volume: 25 | Issue: 9 | Pages: 1701-1711
An increasing number of patients have refractory angina despite optimal medical therapy and are without further revascularization options. Preclinical studies indicate that human CD34 + stem cells can stimulate new blood vessel formation in ischemic myocardium, improving perfusion and function. In ACT34-CMI ( N = 167), patients treated with autologous CD34 + stem cells had improvements in angina and exercise time at 6 and 12 months compared to placebo; however, the longer-term effects of this treatment are unknown. ACT34 was a phase II randomized, double-blind, placebo-controlled clinical trial comparing placebo, low dose (1 × 10 5 CD34/kg body weight), and high dose (5 × 10 5 CD34/kg) using intramyocardial delivery into the ischemic zone following NOGA ® mapping. To obtain longer-term safety and efficacy in these patients, we compiled data of major adverse cardiac events (MACE; death, myocardial infarction, acute coronary syndrome, or heart failure hospitalization) up to 24 months as well as angina and quality of life assessments in patients who consented for 24-month follow-up. A total of 167 patients with class III–IV refractory angina were randomized and completed the injection procedure. The low-dose-treated patients had a significant reduction in angina frequency ( p = 0.02, 0.035) and improvements in exercise tolerance testing (ETT) time ( p = 0.014, 0.017) compared to the placebo group at 6 and 12 months. At 24 months, patients treated with both low-and high-dose CD34 + cells had significant reduction in angina frequency ( p = 0.03). At 24 months, there were a total of seven deaths (12.5%) in the control group versus one (1.8%) in the low-dose and two (3.6%) in the high-dose ( p = 0.08) groups. At 2 years, MACE occurred at a rate of 33.9%, 21.8%, and 16.2% in control, low-, and high-dose patients, respectively ( p = 0.08). Autologous CD34 + cell therapy was associated with persistent improvement in angina at 2 years and a trend for reduction in mortality in no-option patients with refractory angina.