Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT01020968
Brief Summary:
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).
Detailed Description:
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:
NCT01020968
Study Brief:
Protocol Section:
NCT01020968