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Higher doses of CD34+ cells may improve functional recovery from STEMI
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Doses of between 10 and 15 million CD34+ cells, when compared to lesser amounts, were shown in a study to improve resting perfusion at six months in patients following STEMI. These findings have recently led to the first U.S. patent being issued for a chemotactic hematopoietic stem cell product, its delivery and the cell potency and stability needed to treat the consequences of a vascular injury, according to a press release.
The phase 1 multicenter, prospective, cohort-controlled trial determined the feasibility and safety of isolating bone marrow CD34+ cells with patented technology (AMR-001, Amorcyte) from patients after acute STEMI and infusing them into the infarct-related artery.
Thirty-one patients were randomly assigned to either control (n=15; 52.1± 7.8 years) or treatment (n=16; mean age, 53.3 ± 10.5 years) groups, with the latter undergoing cell harvest with a mini-bone marrow aspiration technique (mean volume, 409 mL) 5 days after presenting with STEMI. Researchers performed Isolex selection on harvested bone marrow to obtain CD34+ cells at five, 10 and 15 million cell doses, and infused selected CD34+ cells via the infarct-related artery at 7 to 10 days after successfully treated STEMI.
According to researchers, cell harvest and infusion was safe, with no excess serious adverse events observed in the treatment group. Resting perfusion by SPECT total severity score improved at six months in patients receiving 10 and 15 million cells (n=9) vs. controls and those receiving 5 million cells (n=18; -256 vs. +13; P=.01). There were also non-significant trends toward improvement for ejection fraction (4% vs. 1%), end systolic volume (–5.7 mL vs. –0.1 mL) and infarct size (–10% vs. –3%) at 6 months in subjects receiving 10 and 15 million cells vs. the control group and those given 5 million cells.
“Intracoronary infusion of autologous bone marrow CD34+ cells during the repair phase after STEMI at higher doses than previously administered is safe, and may be associated with improved functional recovery from enhanced perfusion to the peri-infarct zone,” the researchers concluded.
The study results were presented in a poster by Arshed A. Quyyumi, MD, of Emory University, and colleagues, in 2009 at the American College of Cardiology Annual Scientific Sessions.
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