Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00765518|
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : May 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dilated Cardiomyopathy||Biological: Ixmyelocel-T Other: Standard of Care||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intramyocardial Delivery of Autologous Bone Marrow Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||September 5, 2012|
|Actual Study Completion Date :||September 5, 2012|
The treatment arm of the study will receive injections of the study cellular product.
CRCs will be administered via direct injection into the heart muscle.
Standard of Care
Standard of care therapy only.
Other: Standard of Care
Because the eligible patients had no other cardiac surgery or percutaneous cardiac interventions that were likely to produce clinical improvement, SOC was limited to pharmacologic therapy, heart transplant, or ventricular assist device therapy.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765518
|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|