Trial record 3 of 85 for:    "Dilated cardiomyopathy"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aastrom Biosciences
ClinicalTrials.gov Identifier:
NCT00765518
First received: October 2, 2008
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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).


Condition Intervention Phase
Dilated Cardiomyopathy
Biological: Cardiac Repair Cells (CRCs)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intramyocardial Delivery of Autologous Bone Marrow Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Aastrom Biosciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2008
Study Completion Date: February 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
The Treatment arm of the study will receive standard of care therapy, a bone marrow aspiration and injections of the study cellular product.
Biological: Cardiac Repair Cells (CRCs)
CRCs will be administered via direct injection into the heart muscle.
Other Name: autologous bone marrow cells
No Intervention: Control
Standard of care therapy only. Patients in the control group may be offered the opportunity to receive CRC treatment in an open label cross-over protocol after completing at least 6 months of treatment. To determine whether this option will be available, the Data Safety Monitoring Board (DSMB) will review safety and efficacy data from the first 20 CRC treatment patients who have completed at least 6 months of follow-up. The DSMB will make a recommendation regarding cross-over CRC treatment for control patients after review of the data and risk benefit profile.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765518

Locations
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
Sponsors and Collaborators
Aastrom Biosciences
Investigators
Principal Investigator: Amit Patel, MD University of Utah
  More Information

No publications provided

Responsible Party: Aastrom Biosciences
ClinicalTrials.gov Identifier: NCT00765518     History of Changes
Other Study ID Numbers: ABI-55-0712-1
Study First Received: October 2, 2008
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Aastrom Biosciences:
Ischemic Dilated Cardiomyopathy
Non-Ischemic Dilated Cardiomyopathy
ixmyelocel-T

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Heart Failure
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014