PRECISE is The Randomized Clinical Trial of Adipose-Derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium, a double blind, placebo-controlled trial involving 27 patients with chronic ischemic heart disease with HF, angina or both, who were not eligible for percutaneous or surgical revascularization. The patients in the study underwent a liposuction to remove adipose tissue from their abdomen, the stem cells were separated and then reinjected directly into the heart. Placebo patients received the same treatment however were injected with placebo in place of stem cells. “These patients were not even able to be transplanted. So these were very high-risk, no-option patients,” said Francisco Fernández-Avilés, MD, with the department of cardiology, Hospital General Universitario Gregorio Marañón, Madrid, and PRECISE investigator.
The patients who were treated with stem cells had improved infarct size at 6 months and peak oxygen consumption compared to the placebo patients. “In my opinion, the results of the PRECISE trial are good enough to reconsider the possibility to start a larger scale randomized trial comparing cells to placebo in terms of left ventricular function, mainly clinical outcomes [like] mortality, HF and ischemia,” Fernández-Avilés said. For the years ahead, Fernández-Avilés said in patients with chronic HF and viability, the answer for stem cell therapy is adipose tissue, “and for patients with no viability, in my opinion, we need more basic investigation to find more effective cells.”