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

Completed · Phase 2

Conditions studied: Dilated Cardiomyopathy

In brief

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).

Key facts

Study ID

NCT00765518

Run by

Vericel Corporation

People needed

40

Starts

2008-09-01

Expected to finish

2012-09-05

Last updated by the study team

2021-05-27

Who can join

Age: 18 and older, up to 86. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Cleveland Clinic Heart and Vascular Institute — Cleveland, Ohio, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Methodist DeBakey Heart & Vascular Center — Houston, Texas, United States
• The University of Utah School of Medicine — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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