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Clinical data

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    CardioCell reports Phase IIa heart failure data
    Data presented at the European Society of Cardiology meeting in Rome showed that a single intravenous administration of ischemic-tolerant mesenchymal stem cells (itMSCs) from CardioCell LLC met the primary safety endpoint and several secondary efficacy endpoints in a single-blind Phase IIa trial to treat chronic heart failure (CHF) in patients with non-ischemic cardiomyopathy.
    CardioCell CEO Sergey Sikora told BioCentury that IV itMSCs met the primary endpoint of the study by showing no differences versus placebo on multiple safety measures including all-cause mortality and all-cause hospitalizations. "The patient population in this trial consisted of stable, NYHA Class 2 and 3 CHF patients. Thus, few-to-no major events were expected in both groups," Sikora said. The trial enrolled 22 patients who were evaluated at baseline and 90 days after treatment.
    Patients who received IV itMSCs led to significant improvements from baseline to 90 days post-treatment compared with placebo on the six-minute walk test (p=0.02) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary scores (p=0.02), both secondary endpoints. The treatment missed a third secondary endpoint of improving KCCQ functional status scores vs. placebo (p=0.06).
    The clinical summary score assesses symptoms and physical limitations of heart failure and includes the functional status score, along with symptoms and quality of life.
    Sikora said the company expects to advance the candidate to a new clinical study by 2Q17, but did not disclose details on study design.
    CardioCell is a subsidiary of Stemedica Cell Technologies Inc. (San Diego, Calif.). Back to top
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