Public  release date: 6-Nov-2012  [ |   E-mail   |  Share    ]  
    Contact: Steve Goodyear    sgoodyear@mhif.org    952-807-8365    Minneapolis Heart Institute    Foundation
    MINNEAPOLIS, MN  November 6, 2012  Administering autologous    stem cells obtained from bone marrow either 3 or 7 days    following a heart attack did not improve heart function six    months later, reports a new clinical trial supported by the    National Institutes of Health. The results of this trial,    called TIME (Transplantation In Myocardial Infarction    Evaluation), were presented by Jay Traverse, MD of the    Minneapolis Heart Institute Foundation Tuesday, Nov. 6, at the    2012 Scientific Sessions of the American Heart Association in    Los Angeles.  
    The results of this trial mirror a previous, related study    (LateTIME) which found that autologous bone marrow stem cell    therapy given 2-3 weeks after a heart attack did not improve    cardiac recovery. Both TIME and LateTIME were carried out by    the Cardiovascular Cell Therapy Research Network (CCTRN),    sponsored by the NIH's National Heart, Lung, and Blood    Institute.  
    "The data presented by TIME do much to advance stem cell    therapy research," said Jay Traverse, MD of the Minneapolis    Heart Institute Foundation and Principal Investigator of this    study. "While this study did not provide a demonstrated cardiac    benefit after six months, we still learned a great deal.    Together, TIME and Late TIME have shown that stem cell therapy    is safe, and they have set a baseline in terms of quantity of    stem cells, type of stem cells, and severity of heart attack."  
    TIME enrolled 120 volunteers (avg. age 57) between July 2008    and February 2011; the participants all had moderate to severe    impairment in their left ventricle and had undergone coronary    stent placement as treatment for the heart attack. The    participants were randomly assigned to one of four groups: day    3 stem cell, day 3 placebo (inactive cells), day 7 stem cell,    or day 7 placebo. The CCTRN researchers developed a method of    processing and purifying the stem cells from the bone marrow of    each volunteer to ensure everyone received a uniform dose (150    million stem cells).  
    Heart improvement was assessed six months after stem cell    therapy by measuring the percentage of blood that gets pumped    out of the left ventricle during each contraction    (left-ventricular ejection fraction, or LVEF). The study found    no significant differences between the change in LVEF readings    at the six month follow-up in either the Day 3 or Day 7 stem    cell groups compared with placebo or with each other; every    group showed about a 3 percent improvement in LVEF. However,    the researchers found that younger patients randomized to Day 7    had greater improvement in their LVEF compared to their placebo    counterparts  
    "The lack of six-month improvement seen for TIME and, prior to    that, LateTIME, does not mean stem cell therapy is not a viable    post-heart attack strategy," said Traverse. "Because we have    this data we can start to address some parameters; for example    this therapy may work better in younger people, or maybe we    need to use cells from healthy volunteers (allogeneic) since    their cells may provide greater therapeutic benefit. There will    also be upcoming studies using novel cell types which we look    forward to using in future clinical trials."  
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Stem cell therapy using patient's own cells after heart attack does not enhance cardiac recovery