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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Vericel Corporation

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Vericel Corporation

Dates:
Date Received: November 25, 2009
Date Started: December 2009
Date Completion:
Last Updated: November 2, 2016
Last Verified: November 2016