Status:
COMPLETED
Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM)
Lead Sponsor:
Vericel Corporation
Conditions:
Dilated Cardiomyopathy
Eligibility:
All Genders
18-86 years
Phase:
PHASE2
Brief Summary
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).
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00765518
Start Date
September 1 2008
End Date
September 5 2012
Last Update
May 27 2021
Active Locations (5)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Cleveland Clinic Heart and Vascular Institute
Cleveland, Ohio, United States, 44195
3
Baylor University Medical Center
Dallas, Texas, United States, 75226
4
Methodist DeBakey Heart & Vascular Center
Houston, Texas, United States, 77030