Clinical Trial: Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Intramyocardial Delivery of Autologous Bone Marrow Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy
Brief Summary: This study is designed to assess the safety and tolerability of Cardiac Repair Cells (CRCs) compared to standard-of-care in 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. 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.
This study is targeting a subset of heart failure patient population, namely those diagnosed with dilated cardiomyopathy (DCM). The World Health Organization (WHO) defines dilated cardiomyopathy as a cardiac condition wherein a ventricular chamber exhibits increased diastolic and systolic volume and a low (<40%) ejection fraction. DCM is reported to affect 108,000 to 150,000 patients in the U.S.
This study is a prospective, stratified, randomized, open-label, controlled, multi-center study to assess the safety profile and efficacy of CRCs in treating patients with DCM. It will enroll a total of 40 patients at 5 sites in the U.S.
Sponsor: Vericel Corporation
Current Primary Outcome: Safety will be assessed by: post-procedure assessments, physical exam, vital signs, laboratory tests, and adverse events including MACE (Major Adverse Cardiac Event) occurrences. [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
Original Primary Outcome: Incidence of major adverse cardiac event (MACE) (MACE defined as: cardiac death, cardiac arrest, myocardial infarction, ventricular tachycardia, ventricular fibrillation, pulmonary edema, acute heart failure, unstable angina and major bleeding) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
Current Secondary Outcome: Efficacy will be assessed by: MACE, myocardial size, function and perfusion; exercise tolerance, pulmonary function, medication usage, functional status, quality of life, surgical interventions, and blood markers for heart failure [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
Original Secondary Outcome:
- Left ventricular ejection fraction (to be assessed by cine MRI/cardiac CT and Echocardiography) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Change in LV and RV dimensions and volumes as measured by MRI or cardiac CT and Echocardiography [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Wall Motion Score Index (WMSI) (As determined by MRI/cardiac CT or Tissue Doppler Echocardiography. Regional wall motion at rest will be determined by cine MRI using a 17-segment model to yield the WMSI) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Regional myocardial contractility and maximal elasticity in the dysfunctional segments [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Perfusion (To be assessed by Tc-SPECT in patients with IDCM only. In patients unable to perform physical exercise, adenosine will be used.) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- FDG-PET (Measurements in both IDCM and non-IDCM patients performed to determine myocardial perfusion and metabolism) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Physical exercise capacity (to be determined by the change in distance covered during the 6 minute walk test) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Heart failure symptoms (to be determined by the status and changes documented by measurement of MVO2) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) class (to be determined by the status and change from baseline) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Forced Expiratory Volume in 1 second (status and change as assessed by Spirometry according to ATS/ERS guidelines) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Minnesota Living with Heart Failure Score (MLHFQ) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Incidence of implantation/transplantation of implantable devices (implantable device use determined by percentage of patients undergoing ICD implantation, intraaortic balloon pump implantation, Cardiac Assist Device implantation or heart transplantation) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Heart failure markers (as determined by absolute concentrations and changes to the heart failure markers Troponin I and BNP measured in the peripheral blood) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Heart failure medications (e.g. beta-blockers, ACE inhibitors, Digoxin, Diuretics, Vasodilators, Anti-arrhythmic drugs, and Nitroglycerine) [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Assessment of aspiration site throughout study [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Acute post-surgical monitoring of vital signs, special labs and markers, and ECHO [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Assessment of incision site for month following surgery [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Standard chemistry panel including kidney and liver function tests, complete blood count and physical exam, as well as monitoring of vital signs [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Special labs associated with heart function throughout the study, as well as x-ray at 3 mos to evaluate congestion [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Specialized cardiac testing to monitor heart function, i.e., ECG, Holter monitor, ECHO, MRI/CT, SPECT, PET testing [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
- Adverse Event monitoring as well as monitoring specifically for MACE [ Time Frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12 ]
Information By: Vericel Corporation
Dates:
Date Received: October 2, 2008
Date Started: September 2008
Date Completion:
Last Updated: June 29, 2016
Last Verified: June 2016