Data References

NBS10 Phase I clinical trial for AMI (Amorcyte Myocardial Repair Study) on
NBS10 Phase II clinical trial for AMI (NeoStem’s PreSERVE Study) on
Ischemic Repair Fact Sheet
Abstracts for Peer-Reviewed Literature
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Roger, V. L., Go, A. S., Lloyd-Jones, D. M., et al. (2012). Heart disease and stroke statistics–2012 update: a report from the American Heart Association. Circulation, 125(1), e2–e220.
Yeh, R., Sidney, S., & Chandra, M. (2010). Population trends in the incidence and outcomes of acute myocardial infarction. NEJM, 362(23):2155–2165.
Solomon, S. D., Anavekar, N., Skali, H., et al. (2005). Influence of ejection fraction on cardiovascular outcomes in a broad spectrum of heart failure patients. Circulation, 112(24), 3738–44.
Strauer, B.-E., & Steinhoff, G. (2011). 10 Years of Intracoronary and Intramyocardial Bone Marrow Stem Cell Therapy of the Heart: From the Methodological Origin To Clinical Practice. Journal of the American College of Cardiology, 58(11), 1095–104.
Delewi, R., Andriessen, A., Tijssen, J. G. P., et al. (2012). Impact of intracoronary cell therapy on left ventricular function in the setting of acute myocardial infarction: a meta-analysis of randomized controlled clinical trials. Heart (British Cardiac Society).
Zimmet, H., Porapakkham, P., Porapakkham, P., et al. (2012). Short- and long-term outcomes of intracoronary and endogenously mobilized bone marrow stem cells in the treatment of ST-segment elevation myocardial infarction: a meta-analysis of randomized control trials. European journal ofheart failure, 14(1), 91–105.
Schächinger, V., Erbs, S., Elsässer, A., et al. (2006). Improved clinical outcome after intracoronary administration of bone-marrow-derived progenitor cells in acute myocardial infarction: final 1-year results of the REPAIR-AMI trial. European heart journal, 27(23), 2775–83.
Meluzin J, Janousek S, Mayer J, et al. (2008). Three, 6 and 12 month results of autologous transplantation of mononuclear bone marrow cells in patients with acute myocardial infarction. International Journal of Cardiology, 128:185-912.
Britten, M. B., Abolmaali, N. D., Assmus, B., et al. (2003). Infarct remodeling after intracoronary progenitor cell treatment in patients with acute myocardial infarction (TOPCARE-AMI): mechanistic insights from serial contrast-enhanced magnetic resonance imaging. Circulation, 108(18), 2212–8.

Delewi, et al. (2013). Impact of intracoronary bone marrow cell therapy on left ventricular function in the setting of ST-segment elevation myocardial infarction: a collaborative meta-analysis. European Heart Journal, 2013 Sep 11.

Petit, I., Jin, D., & Rafii, S. (2007). The SDF-1-CXCR4 signaling pathway: a molecular hub modulatingneo-angiogenesis. Trends in immunology, 28(7), 299–307.
Sahoo, S., Ph, D., Klychko, E., Thorne, T., et al. (2012). Exosomes from Human CD34+ Stem Cells Mediate their Proangiogenic Paracrine Activity, 109(7), 724–728.
Kaluski E, Kobrin I, Zimlichman R, et al. (2003) RITZ-5: randomized intravenous Tezosentan (an endothelin-A/B antagonist) for the treatment of pulmonary edema: a prospective, multicenter, double-blind, placebo-controlled study. 41(2):204-10.
Silver, M. A, Horton, D. P., Ghali, J. K., & Elkayam, U. (2002). Effect of nesiritide versus dobutamine on short-term outcomes in the treatment of patients with acutely decompensated heart failure. Journal of the American College of Cardiology, 39(5), 798–803.
Sackner-Bernstein, J. D., Kowalski, M., Fox, M., & Aaronson, K. (2005). Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomizedcontrolled trials. JAMA, 293(15), 1900–1905.
Assmus B, Leistner DM, Schächinger V, et al. Long-term clinical outcome after intracoronary application of bone marrow-derived mononuclear cells for acute myocardial infarction: migratory capacity of administered cells determines event-free survival. Eur Heart J. 2014 Feb 25.
Industry Guidance
U.S. Department of Health and Human Services, Food and Drug Administration, CDER, CBER. Guidance for Industry: Exposure-Response Relationships – Study Design, Data Analysis, and Regulatory Applications. April 2003.
U.S. Department of Health and Human Services, Food and Drug Administration, CDER. Guidance for Industry: End-of-Phase 2A Meetings. September 2009.

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