SBIR-STTR Award

Cardiovascular disease (CVD) represents a significant unmet medical need with over 1 million patients in the United States suffering from acute myocardial infarction (AMI) each year. This epidemic of heart attacks also represents a risk factor for further cardiovascular disease, with over 5.9 million individuals suffering from chronic heart failure (CHF) and > 670,000 new patients diagnosed with CHF annually in the United States. CHF is associated with high morbidity and mortality as well as high cost of care. In fact, taken together, CVD is the leading cause of death in the United States and is responsible for an estimated $287 billion dollars annually in direct and indirect costs, according the American Heart As the population ages and the incidence of diabetes and obesity increase, the incidence and associated cost of care for CVD Is expected to rise as well. By 2030, the number of people in US age 65 and over will increase by 80%. Despite the high cost of care and prevalence, the medical options to treat both AMI and CHF are limited. Based on the current clinical data, it would appear highly likely that cell therapy will play a role in the prevention ad treatment of cardiac dysfunction in the ensuing years. In this study, we proposed to develop in the Phase I portion of this proposal, an adult bone-marrow derived cell therapy product, MultiStem, that can formulated in a cryovial for rapid thaw and delivery to treat acute ischemic injury. For the Phase II portion, we plan to investigate the effects of cell therapy in a specific nd novel population of patients with cardiovascular disease, those patients with heart attacks that present as non-ST elevated myocardial infarcts (NSTEMI) to determine if we can reduce the morbidity and mortality and provide functional benefit to the heart. Importantly, the NSTEMI population is growing in prevalence unlike the clinical population of first-time ST elevation AMI which has been steadily declining over the past decade. Successful completion of these studies will provide the data required for a Phase III registration trial that will be required to market MultiStem for the treatment of acute cardiovascular injury.

Public Health Relevance Statement:


Public Health Relevance:
The development of cell therapy for the treatment of acute cardiovascular injury will provide a novel therapeutic for one the leading causes of death in the world.

Project Terms:
Academic Medical Centers; Acute; Acute myocardial infarction; Admission activity; Adopted; Adult; Age; Allogenic; American; base; Biological Assay; Bone Marrow; Cardiac; Cardiovascular Diseases; cardiovascular injury; Cardiovascular system; Caring; Catheters; Cause of Death; cell preparation; Cell Therapy; cell type; Cells; Cessation of life; Chemistry; Chronic; Clinical; Clinical Data; clinical efficacy; Clinical Trials; cost; Data; Death Rate; design; Development; Diabetes Mellitus; Diagnosis; Direct Costs; Distal; Double-Blind Method; Elderly; Epidemic; Event; Facilities and Administrative Costs; Functional disorder; Health system; Heart; Heart Diseases; Heart failure; heart function; Hospitalization; improved; improved functioning; Incidence; Individual; Infarction; Injection of therapeutic agent; Injury; Institution; Investigation; Ischemia; Lead; Left Ventricular Ejection Fraction; manufacturing process; Marketing; Medical; Molecular; Mononuclear; Morbidity - disease rate; Mortality Vital Statistics; Myocardial Infarction; novel; novel therapeutics; Obesity; Outcome; patient population; Patients; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Phase III Clinical Trials; Placebo Control; Play; Population; Populations at Risk; Prevalence; Prevention; Process; Protocols documentation; public health relevance; Quality of life; randomized placebo controlled trial; Recording of previous events; Recurrence; Risk; Risk Factors; Role; Safety; Site; Stem cells; Stents; System; Testing; Time; Translating; Tunica Adventitia; United States; Validation; Venous; Work

Cardiovascular disease (CVD) represents a significant unmet medical need with over 1 million patients in the United States suffering from acute myocardial infarction (AMI) each year. This epidemic of heart attacks also represents a risk factor for further cardiovascular disease, with over 5.9 million individuals suffering from chronic heart failure (CHF) and > 670,000 new patients diagnosed with CHF annually in the United States. CHF is associated with high morbidity and mortality as well as high cost of care. In fact, taken together, CVD is the leading cause of death in the United States and is responsible for an estimated $287 billion dollars annually in direct and indirect costs, according the American Heart As the population ages and the incidence of diabetes and obesity increase, the incidence and associated cost of care for CVD Is expected to rise as well. By 2030, the number of people in US age 65 and over will increase by 80%. Despite the high cost of care and prevalence, the medical options to treat both AMI and CHF are limited. Based on the current clinical data, it would appear highly likely that cell therapy will play a role in the prevention ad treatment of cardiac dysfunction in the ensuing years. In this study, we proposed to develop in the Phase I portion of this proposal, an adult bone-marrow derived cell therapy product, MultiStem, that can formulated in a cryovial for rapid thaw and delivery to treat acute ischemic injury. For the Phase II portion, we plan to investigate the effects of cell therapy in a specific nd novel population of patients with cardiovascular disease, those patients with heart attacks that present as non-ST elevated myocardial infarcts (NSTEMI) to determine if we can reduce the morbidity and mortality and provide functional benefit to the heart. Importantly, the NSTEMI population is growing in prevalence unlike the clinical population of first-time ST elevation AMI which has been steadily declining over the past decade. Successful completion of these studies will provide the data required for a Phase III registration trial that will be required to market MultiStem for the treatment of acute cardiovascular injury.

Public Health Relevance Statement:


Public Health Relevance:
The development of cell therapy for the treatment of acute cardiovascular injury will provide a novel therapeutic for one the leading causes of death in the world.

NIH Spending Category:
Aging; Biotechnology; Cardiovascular; Clinical Research; Clinical Trials and Supportive Activities; Heart Disease; Heart Disease - Coronary Heart Disease; Prevention; Regenerative Medicine; Stem Cell Research; Stem Cell Research - Nonembryonic - Human

Project Terms:
Academic Medical Centers; Acute; Acute myocardial infarction; Admission activity; Adopted; Adult; Age; Allogenic; American; base; Biological Assay; Bone Marrow; Cardiac; Cardiovascular Diseases; cardiovascular injury; Cardiovascular system; Caring; Catheters; Cause of Death; cell preparation; Cell Therapy; cell type; Cells; Cessation of life; Chemistry; Clinical; Clinical Data; clinical efficacy; Clinical Trials; Congestive Heart Failure; cost; Data; Death Rate; design; Development; Diabetes Mellitus; Diagnosis; Direct Costs; Distal; Double-Blind Method; Elderly; Epidemic; Event; Facilities and Administrative Costs; Health system; Heart; Heart Diseases; heart function; Hospitalization; improved; improved functioning; Incidence; Individual; Infarction; Injection of therapeutic agent; Injury; Institution; Investigation; Ischemia; Lead; Left Ventricular Ejection Fraction; manufacturing process; Marketing; Medical; Molecular; Mononuclear; Morbidity - disease rate; mortality; Myocardial dysfunction; Myocardial Infarction; novel; novel therapeutics; Obesity; Outcome; patient population; Patients; Phase; Phase I Clinical Trials; Phase II Clinical Trials; phase II trial; phase III trial; Placebo Control; Play; Population; Populations at Risk; Prevalence; Prevention; Process; Protocols documentation; public health relevance; Quality of life; randomized placebo controlled trial; Recording of previous events; Recurrence; Risk; Risk Factors; Role; Safety; Site; Stem cells; Stents; System; Testing; Time; Translating; Tunica Adventitia; United States; Validation; Venous; Work