Use of Ixmyelocel-T (Formerly Catheter-based Cardiac Repair Cell [CRC])

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01020968
Study type	Interventional
Source	Vericel Corporation
Contact
Status	Completed
Phase	Phase 2
Start date	December 2009
Completion date	December 5, 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05564689` - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
Recruiting	`NCT04982081` - Treating Congestive HF With hiPSC-CMs Through Endocardial Injection	Phase 1
Not yet recruiting	`NCT04703751` - Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents	N/A
Recruiting	`NCT01157299` - Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO	N/A
Completed	`NCT00765518` - Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM)	Phase 2
Completed	`NCT02115581` - Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy	Phase 4
Recruiting	`NCT04246450` - Arrhythmic Risk Stratification in Nonischemic Dilated Cardiomyopathy	N/A
Recruiting	`NCT05799833` - Low QRS Voltages in Young Healthy Individuals and Athletes
Recruiting	`NCT01914081` - Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside	Phase 3
Recruiting	`NCT02915718` - A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy	N/A
Recruiting	`NCT03061994` - Metabolomic Study of All-age Cardiomyopathy	N/A
Completed	`NCT03893760` - Assessment of Right Ventricular Function in Advanced Heart Failure
Not yet recruiting	`NCT01219452` - Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy	Phase 1/Phase 2
Recruiting	`NCT02175836` - Arrhythmia Prediction Trial	N/A
Active, not recruiting	`NCT00962364` - Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease
Recruiting	`NCT05026112` - The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy
Recruiting	`NCT05237323` - Micophenolate Mofetil Versus Azathioprine in Myocarditis	Phase 3
Recruiting	`NCT04649034` - Intraventricular Stasis In Cardiovascular Disease
Suspended	`NCT03071653` - Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study	Phase 2
Completed	`NCT02619825` - Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms