NeoStem, Inc. — Department of Health and Human Services SBIR Phase II: NHLBI

Description

Exploratory Clinical Study to Evaluate the Potential Bioactivity of CLBSin Patients with Coronary Microvascular Dysfunction Project Summary Abstract CLBSis an autologous cell therapy consisting of G CSF mobilized autologous CDcells obtained from peripheral bloodThe primary mode of action is improvement in perfusion by neo angiogenesis and or microvascular function under conditions of inadequate perfusionThe therapeutic focus of the proposed clinical study is coronary microvascular dysfunctionCMDfor which therapeutic strategies are limitedApproximatelysubjects with CMD will be enrolled in the single arm studyThe primary objective is to evaluate the potential bioactivity of intracoronary delivery of autologous CDcellsCLBSin subjects with CMD and no obstructive coronary artery diseaseas determined by invasive testing of coronary microvascular function as determined by assessment of coronary flow reserveCFRAdditional data will be collected on endothelial dependent microvascular function as determined by measurement of coronary blood flow in reaction to acetylcholineendothelial independent microvascular function as determined by measurement of coronary blood flow in reaction to adenosineperipheral arterial tonometryquality of life as measured with an angina diarySeattle Angina QuestionnaireSAQand a health related quality of life questionnaireexercise tolerance as assessed by treadmill testing and by recording of daily activities with a FitbitThe study is being designed and implemented by well regarded investigators in CDcell therapy and ischemic cardiac diseaseDrDouglas Losordo from Caladrius Biosciences is the sponsor and study director and the investigators are DrTimothy Henry and Noel Bairey Merz of Cedars Sinai Medical Center and DrAmir Lerman of the Mayo ClinicCedars Sinai and Mayo Clinic are co investigators on the grantProduct manufacturing is provided by PCTa Caladrius Company and a recognized leader in contract cell therapy manufacturingFor preparation of CLBSeach patient is treated with G CSF for up todays to mobilize CDcells from the bone marrow and into peripheral bloodEach patient undergoes apheresis to provide the starting material for manufacturing CLBSThe apheresis material is processed to separate and enrich CDcellswhich are then formulated for administration back to the patient via intra coronary infusionFollowing infusion of CLBSpatients are monitored for safety and efficacy endpoints for up to one yearIt is expected that the trial will take approximatelyyears to completeResults from the research will be presented in one or more public forums and published in a peer reviewed journalWith the novel angiogenic mechanism of action of CLBSand specifically targeting coronary microvascular dysfunction to improve coronary microvascular flow responsible for the major adverse cardiac events and poor quality of life in this populationthis project will be a strong contributor to NIH s mission to develop new and effective therapies for underserved diseasesCaladrius BiosciencesProprietary and ConfidentialExploratory Clinical Study to Evaluate the Potential Bioactivity of CLBSin Patients with Coronary Microvascular Dysfunction Project Narrative Coronary microvascular dysfunctionCMDwhich predominantly effects womencauses ischemic chest pain and increases the risk of major adverse coronary events however at presentthere is no specific therapy available to treat CMDCLBSis an autologous cell therapy consisting of G CSF mobilized autologous CDcells obtained from peripheral blood which has been shown promote angiogenesis under conditions of inadequate perfusionsuch as CMDThis study will test the hypothesis that CLBSimproves microvascular function in CMD patients and may therefore improves symptoms and outcomes in the setting of this currently unmet medical needCaladrius BiosciencesProprietary and Confidential