NCT01020968

Use of Ixmyelocel-T (Formerly Catheter-based Cardiac Repair Cell [CRC]) Treatment in Patients With Heart Failure Due to Dilated Cardiomyopathy

Catheter-based Transendocardial Delivery of Autologous Bone Marrow-Derived Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Vericel Corporation · Industry
• Sex: All
• Age: 18 Years – 86 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dilated Cardiomyopathy

Interventions

Type	Name	Description
BIOLOGICAL	Ixmyelocel-T	CRCs will be administered via catheter-based injection to the endocardial surface of the left ventricle.
OTHER	Vehicle Control	will receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control into the left ventricle.

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-01-11
• Completion: 2013-12-05
• First posted: 2009-11-26
• Last updated: 2021-05-27

Locations

3 sites across 1 country: United States