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

NCT00765518 | Completed Phase 2 DMC

• 1 other identifier: ABI-55-0712-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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).

Conditions

Dilated Cardiomyopathy

Keywords

Ischemic Dilated Cardiomyopathy; Non-Ischemic Dilated Cardiomyopathy; ixmyelocel-T

Outcome Measures

Primary Outcomes (1)

• Safety will be assessed by: post-procedure assessments, physical exam, vital signs, laboratory tests, and adverse events including MACE (Major Adverse Cardiac Event) occurrences.

  Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12

Secondary Outcomes (1)

• 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

  Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12

Study Arms (2)

Ixmyelocel-T

EXPERIMENTAL

The treatment arm of the study will receive injections of the study cellular product.

Biological: Ixmyelocel-T

Standard of Care

OTHER

Standard of care therapy only.

Other: Standard of Care

Interventions

Ixmyelocel-T BIOLOGICAL

CRCs will be administered via direct injection into the heart muscle.

Ixmyelocel-T

Standard of Care OTHER

Because the eligible patients had no other cardiac surgery or percutaneous cardiac interventions that were likely to produce clinical improvement, SOC was limited to pharmacologic therapy, heart transplant, or ventricular assist device therapy.

Standard of Care

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vericel Corporation: lead

Study Sites (5)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Cleveland Clinic Heart and Vascular Institute

Cleveland, Ohio, 44195, United States

Location

Baylor University Medical Center

Dallas, Texas, 75226, United States

Location

Methodist DeBakey Heart & Vascular Center

Houston, Texas, 77030, United States

Location

The University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• Henry TD, Traverse JH, Hammon BL, East CA, Bruckner B, Remmers AE, Recker D, Bull DA, Patel AN. Safety and efficacy of ixmyelocel-T: an expanded, autologous multi-cellular therapy, in dilated cardiomyopathy. Circ Res. 2014 Sep 26;115(8):730-7. doi: 10.1161/CIRCRESAHA.115.304554. Epub 2014 Aug 20.

  PMID: 25142002 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Amit Patel, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: September 1, 2008
• Primary Completion: September 5, 2012
• Study Completion: September 5, 2012
• Last Updated: May 27, 2021

Record last verified: 2021-05

Locations

US (5)