PRECISE: Adipose-derived stem cells show utility as therapy

Issue: April 2011

Patients with ischemic heart disease treated with stem cells derived from adipose tissue had improved infarct size at 6 months and peak oxygen consumption at 18 months compared with those taking a placebo, according to new data from the PRECISE trial presented at the Sixth International Conference on Cell Therapy for Cardiovascular Disease.

The Randomized Clinical Trial of Adipose-Derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium (PRECISE) was 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.

“These patients were not even able to be transplanted. So these were very high-risk, no-option patients,” Francisco Fernández-Avilés, MD, with the department of cardiology, Hospital General Universitario Gregorio Marañón, Madrid, and PRECISE investigator, told Cardiology Today.

The patients were randomly assigned 3:1 to either treatment with adipose-derived stem and regenerative cells (ADRC; Celution 800, Cytori Therapeutics; n=21; mean age, 65.8 ± 6.3 years) or placebo (control; n=6; mean age, 55.7 ± 6.1 years). The ADRC treatment utilizes a process that withdraws fat tissue from the abdomen, separates regenerative cells and re-injects them into the patient’s heart; all at the patient’s bedside. Patients in the placebo arm were given the same procedure with the exception of a placebo being injected in the place of stem cells.

Overall, major adverse cardiac and cerebrovascular events between 30 days and 1 year were similar between groups, as was mortality at a mean follow-up of 28 months.

Compared with the control group, treatment group patients at 6 months had an improved infarct size (22.1% vs. 28.9%; P=.04), whereas left ventricular ejection fraction was lower (45% vs. 48%). At 18 months, metabolic equivalents (P=.03) and peak oxygen consumption (P=.03) were improved in the treatment arm.

“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.”

Disclosure: Dr. Aviles reported no relevant financial disclosures.

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