ORLANDO -- Adipose-derived regenerative cells appeared to help patients with refractory ischemia in the ATHENA trials, a researcher said here, despite an early stop because of adverse events.
At 1 year, patients receiving the autologous cells had a better enhancement in quality of life (Minnesota Living with Heart Failure Questionnaire -21.6 points versus -5.5 for placebo, P=0.038) and overall improvement in symptoms (P<0.05), according to Timothy D. Henry, MD, of Cedars-Sinai Heart Institute in Los Angeles.
No improvement in LVEF was seen, however, according to Henry’s presentation at annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI). The report was simultaneously published online in Catheterization and Cardiovascular Interventions.
At 6 months, patients who received a combination of adult stem cells, vascular endothelial cells, and smooth muscle cells (among other cell types) showed the following favorable trends, which did not reach statistical significance:
- Higher maximum VO2 values (+45.4 mL/min versus -9.5 mL/min for placebo)
- More physical activity (New York Heart Association category improvement for 47% versus 31%)
- Less severe angina (Canadian Cardiovascular Society improvement for 62% versus 27%)
Participants underwent liposuction of less than 450 mL adipose per patient, which was processed into adipose-derived regenerative cells that were injected into viable myocardium.
“A small volume fat harvest, followed by automated local processing, and intramyocardial delivery of autologous adipose-derived regenerative cells is feasible,” Henry told SCAI attendees at an oral session.
The randomized, double-blind trials ATHENA I and II enrolled 31 patients before they were halted on account of neurological events in three patients, attributed to transient ischemic attacks.
“No patient had a real stroke. These were minor events,” Henry said. “We had strict stopping rules, so the lesson is that we should leave it up to the Data and Safety Monitoring Board in the future.”
“Observed cerebrovascular events indicated [the] need for patient selection and peri-procedure diligence,” he added.
“Although the sample size is limited, the findings support feasibility and scalability for use of adipose-derived regenerative cells for treatment of ischemic heart disease,” Henry concluded. “There is interest to pursue this.”
The ATHENA trials were sponsored by Cytori.
Henry declared no relevant relationships with industry.
Society for Cardiovascular Angiography and Interventions
Henry TD, et al “Final results for the ATHENA trials: autologous adipose derived regenerative cells (ADRCs) for refractory chronic myocardial ischemia with left ventricular (LV) dysfunction” SCAI 2016; Abstract 14820.