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    Home > Active Ingredient News > Drugs Articles > FDA Approves New plx-pad test

    FDA Approves New plx-pad test

    • Last Update: 2012-04-19
    • Source: Internet
    • Author: User
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    Source: China Council for the promotion of drugs 2012-04-19 pluristem treatment Co., Ltd announced that it has been approved by the U.S Food and Drug Administration (FDA) to start phase II clinical trials of its candidate cell product plx-pad for the treatment of intermittent claudication (IC), a kind of peripheral arterial disease (PAD) The phase II IC trial of pluristem will evaluate the efficacy and safety of plx-pad cells after two doses (150x106 and 300x106) of intramuscular injection once a day and 12 injections a week after the end of initial treatment compared with placebo In this study, 132 IC patients (44 patients in a group) with Fontaine class IIB and Rutherford class 2-3 were selected and tested in about 10 sites in the United States The main efficacy end point of the trial was determined by the change of the maximum walking distance and baseline of the treadmill exercise test during the treatment period Secondary endpoints will include hemodynamic and quality of life tests The test will also test safety parameters Original link: http://www.dddmag.com/news/2012/04/fda-approvals-new-plx-pad-trial
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