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

Vericel

Status and phase

Completed

Phase 2

Conditions

Dilated Cardiomyopathy

Treatments

Other: Standard of Care

Biological: Ixmyelocel-T

Study type

Interventional

Funder types

Industry

Identifiers

NCT00765518

ABI-55-0712-1

Details and patient eligibility

About

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).

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18 to 86 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of ischemic or nonischemic DCM according to World Health Organization criteria; OR ischemic DCM (DCM in a patient with a history of myocardial infarction or evidence of clinically significant (>/= 70% narrowing of a major epicardial artery) coronary artery disease)
No other cardiac surgery or percutaneous cardiac interventions likely to produce clinical improvement, in the opinion of the investigator and the referring interventional cardiologist
Left ventricular ejection fraction </= 30% by echocardiogram
Symptomatic heart failure in NYHA functional class III or IV
Able to comply with scheduled visits in cardiac out-patient clinic
Able to tolerate study procedures, including bone marrow aspiration, left lateral thoracotomy or thoracoscopy with single lung ventilation, MRI or cardiac CT, spirometry and 6 minute walk test
Males and females, 18-86 years of age
Life expectancy of 6 months or more in the opinion of investigator
Able to give informed consent
Normal organ and marrow function (Leukocytes >/= 3,000/microgram, Absolute neutrophil count >/= 1,500/microgram, Platelets >/= 140,000/microgram, AST (SGOT)/ALT (SGPT) </= 2.5 x institutional standards range) and Creatinine </= 2.5 mg/dL)
Adequate pulmonary function (forced expiratory volume in one second [FEV1] > 50% predicted)
Controlled blood pressure (systolic blood pressure </= 140; diastolic blood pressure </= 90 mmHg) and established anti-hypertensive therapy as necessary prior to entry into the study
Adequate medical management of DCM and other pre-existing conditions. Drug treatment regimen must have been established for at least a month prior to randomization in eligible patients.
Fertile patients must agree to use an appropriate form of contraception while participating in the study

Exclusion criteria

Severe primary valvular insufficiency(ies)
Known history of Chronic Obtrusive Pulmonary Disease (Gold stages IIB or more severe only) or restrictive pulmonary disease
Known history of primary pulmonary hypertension
Ventricular Assist Device implantation
Myocardial infarction within 4 weeks of randomization
Life-threatening ventricular arrhythmia, except if implantable cardioverter defibrillator is implanted
Unstable angina, characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration
Patients receiving treatment with hematopoietic growth factors
Patients who require uninterruptible anticoagulation or anti-platelet therapy [i.e. anticoagulation therapy (e.g. warfarin) that cannot be stopped for 72 hours prior to bone marrow aspiration and intramyocardial injections]
Patients receiving anti-platelet therapy (e.g. clopidogrel) that cannot be stopped for 7 days prior to bone marrow aspiration and intramyocardial injections
Known cancer and undergoing treatment including chemotherapy and radiotherapy
Patients who will require continuous, systemic, high dose corticosteroid therapy (more than 7.5 mg/day) within 6 months after surgery
End stage renal disease requiring dialysis
Patients pregnant or lactating; positive for hCG
History of alcohol consumption regularly exceeding the equivalent of 2 drinks/day (1 drink = 5 oz of wine or 12 oz [360mL] of beer or 1.5 oz [45mL] of hard liquor) or history of illicit drug use within 6 months of screening
Known allergies to protein products (horse or bovine serum, or porcine trypsin)
Body Mass Index of 40 Kg/m2 or greater
Patients receiving experimental medications or participating in another clinical study within 30 days of screening
HIV or syphilis, positive at time of screening
Active Hepatitis B, or Hepatitis C infection at time of screening
In the opinion of the investigator, patient is unsuitable for cellular therapy
Patients receiving anti-angiogenic drugs