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Baxter commences trial of stem cells in coronary artery disease

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  • Baxter commences trial of stem cells in coronary artery disease

    Clinical trial to begin for stem cell treatment in heart patients

    Knight Ridder - Monday, March 06, 2006

    Chicago Tribune
    By Bruce Japsen

    CHICAGO _ A treatment that uses adult stem cells to rebuild failing hearts _ once believed to be impossible _ will undergo a pivotal test starting this week in a 150-patient clinical trial under the watch of Baxter International Inc.

    On Tuesday the Deerfield, Ill.-based medical products giant is expected to announce the launch of the first U.S.-approved phase II study of adult stem cells to create new blood vessels in the cardiovascular system. The phase II study _ a second, larger and more detailed experiment allowed after basic safety is established _ is designed to investigate whether injecting adult stem cells directly into the heart can help patients rebound from severe coronary artery disease.

    The first trial of just 24 patients was impressive enough to allow Baxter to move on to the second of three phases typically required by the U.S. Food and Drug Administration. In the first phase, most patients needed to take fewer nitrate tablets and could resume routine activities such as walking or retrieving the mail _ tasks they were unable to do before the trial began.

    A successful trial could put Baxter in the lead in U.S. development of a potentially lucrative business. Heart disease is the single leading cause of death in America, responsible for an estimated one in every five deaths.
    (c) 2006, Chicago Tribune.

  • #2
    Baxter commences trial of stem cells in coronary artery disease

    This is interesting because it is a major pharmaceutical firm that is evaluating blood-derived selected CD34+ stem cells. Most of the other trials are academic. This is the first "big" pharma stem cell trial.



    Baxter commences trial of stem cells in coronary artery disease
    8th March 2006
    By Staff Writer
    Baxter Healthcare has initiated a first-of-its-kind phase II trial in the US to evaluate blood-derived selected CD34+ stem cells in the treatment of chronic myocardial ischemia, a severe form of coronary artery disease.

    Chronic myocardial ischemia (CMI) is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart, affecting hundreds of thousands of new patients each year.

    This prospective, randomized, double-blind, placebo-controlled, multi-center study will involve approximately 150 adult patients who are currently on maximal medical therapy and are not suitable candidates for conventional procedures to improve blood flow to the heart, such as angioplasty, stents, or coronary artery bypass surgery.

    "Baxter's sponsorship of this trial is consistent with our mission to be a leader in providing innovative life-saving therapies, and to pursue new opportunities where our technology can potentially help save and sustain lives," said Dr Norbert Riedel, Baxter's chief scientific officer.


    • #3
      another mention


      • #4
        Thanks, I merged the two threads to consolidate discussion. Wise.