This study is designed to assess the safety profile and the efficacy of cardiac repair cells (CRCs) administered via catheter in treating patients with dilated cardiomyopathy (DCM).
Heart failure remains a major public health problem, affecting 5 million patients in the US, with 550,000 new diagnoses made each year (Hunt SA; et al., 2005). Heart failure is the leading cause of hospitalization in persons over 65 years of age with cost exceeding $29 billion annually. Prognosis is very poor once a patient has been hospitalized with heart failure. The mortality risk after heart failure hospitalization is 11.3% at 30 days, 33.1% at 1 year and well over 50% within 5 years (Hunt SA; et al., 2005). These numbers emphasize the need to develop and implement more effective treatments to manage heart failure. Aastrom is targeting a subset of heart failure patient population, namely those diagnosed with dilated cardiomyopathy. The World Health Organization (WHO) defines dilated cardiomyopathy (DCM) as a cardiac condition wherein a ventricular chamber exhibits increased diastolic and systolic volume and a low (\<40%) ejection fraction (Manolio TA; et al., 1992; Towbin JA; et al., 2006). DCM is reported to affect 108,000 to 150,000 patients in the United States (Richardson P; et al., 1996; Towbin JA; et al., 2006). This study is a prospective, stratified, randomized, open-label, controlled, multi-center study to assess the safety profile and the efficacy of CRCs administered via catheter in treating patients with DCM. Two strata will be used: ischemic (IDCM) and non-ischemic (NIDCM). Within each stratum, patients will be randomized to receive either CRC treatment or control in a 2:1 ratio (8 patients per CRC treatment group and 4 patients per control group). It will enroll a total of 24 patients at 2 sites in the U.S.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
CRCs will be administered via catheter-based injection to the endocardial surface of the left ventricle.
will receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control into the left ventricle.
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University Hospitals, Case Western Reserve University
Cleveland, Ohio, United States
University of Utah
Salt Lake City, Utah, United States
Incidence of major adverse cardiac event (MACE) (MACE defined as: cardiac death, cardiac arrest, myocardial infarction, sustained ventricular arrhythmias, pulmonary edema, acute heart failure, unstable angina and major bleeding)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Left ventricular ejection fraction (LVEF) (As determined by Echo, Cardiac CT and SPECT)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
Change in LV and RV dimensions and in LV volumes (As determined by Echo, Cardiac CT and SPECT)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
Wall Motion Score Index (WMSI) (As determined by Echo, Cardiac CT and SPECT)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
Assessment of myocardial perfusion in ischemic patient cohort, only (As determined by SPECT)
Time frame: Baseline and Month 3
Exercise tolerance (6 minute walk test)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Heart failure status (As determined by New York Heart Association (NYHA) heart failure status (NYHA) class and Brain Natriuretic Peptide [BNP])
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
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Angina status (As determined by Canadian Cardiovascular Society (CCS) classification and Troponin I Levels)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Quality of life (As determined by Minnesota Living with Heart Failure Questionnaire [MLHFQ])
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Pulmonary function (As determined by metabolic stress test)
Time frame: Baseline, Month 6 and Month 12
Device implantation, transplantation and positive inotrope use (As determined by incidence rates)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
AICD firing rate
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Changes in medication for heart failure
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12