Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intramyocardial Delivery of Autologous Bone Marrow Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
The Treatment arm of the study will receive standard of care therapy, a bone marrow aspiration and injections of the study cellular product.
Biological: Cardiac Repair Cells (CRCs)
CRCs will be administered via direct injection into the heart muscle.
Other Name: autologous bone marrow cells
No Intervention: Control
Standard of care therapy only. Patients in the control group may be offered the opportunity to receive CRC treatment in an open label cross-over protocol after completing at least 6 months of treatment. To determine whether this option will be available, the Data Safety Monitoring Board (DSMB) will review safety and efficacy data from the first 20 CRC treatment patients who have completed at least 6 months of follow-up. The DSMB will make a recommendation regarding cross-over CRC treatment for control patients after review of the data and risk benefit profile.
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.
|United States, Georgia|
|Emory University Hospital Midtown|
|Atlanta, Georgia, United States, 30308|
|United States, Ohio|
|Cleveland Clinic Heart and Vascular Institute|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75226|
|Methodist DeBakey Heart & Vascular Center|
|Houston, Texas, United States, 77030|
|United States, Utah|
|The University of Utah School of Medicine|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Amit Patel, MD||University of Utah|