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

NCT01020968 | Completed Phase 2 DMC

• 1 other identifier: ABI-55-0811-1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

This study is designed to assess the safety profile and the efficacy of cardiac repair cells (CRCs) administered via catheter in treating patients with dilated cardiomyopathy (DCM).

Conditions

Dilated Cardiomyopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of major adverse cardiac event (MACE) (MACE defined as: cardiac death, cardiac arrest, myocardial infarction, sustained ventricular arrhythmias, pulmonary edema, acute heart failure, unstable angina and major bleeding)

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

Secondary Outcomes (12)

• Left ventricular ejection fraction (LVEF) (As determined by Echo, Cardiac CT and SPECT)

  Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.

• Change in LV and RV dimensions and in LV volumes (As determined by Echo, Cardiac CT and SPECT)

  Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.

• Wall Motion Score Index (WMSI) (As determined by Echo, Cardiac CT and SPECT)

  Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.

• Assessment of myocardial perfusion in ischemic patient cohort, only (As determined by SPECT)

  Baseline and Month 3

• Exercise tolerance (6 minute walk test)

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

Study Arms (2)

Ixmyelocel-T

EXPERIMENTAL

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

Biological: Ixmyelocel-T

Vehicle Control

PLACEBO COMPARATOR

will receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control.

Other: Vehicle Control

Interventions

Ixmyelocel-T BIOLOGICAL

CRCs will be administered via catheter-based injection to the endocardial surface of the left ventricle.

Ixmyelocel-T

Vehicle Control OTHER

will receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control into the left ventricle.

Vehicle Control

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 non-ischemic dilated cardiomyopathy according to WHO criteria. Ischemic: 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. Non-ischemic: Dilation and impaired contraction of left ventricle or both ventricles of idiopathic, familial/genetic, viral and/or immune, toxic origin, or associated with recognized cardiovascular disease in which the degree of myocardial dysfunction is not explained by normal loading conditions or the extent of ischemic damage.
• No other cardiac surgery or percutaneous cardiac interventions likely to produce clinical improvement, as determined by an interventional cardiologist (for PTCA) and a cardiothoracic surgeon (for CABG). This condition is satisfied in patients w/chronic ischemic disease who have previously been successfully revascularized but have failed to show clinical improvement. All patients who are candidates for revascularization are ineligible for participation.
• LVEF \</= 30% by echocardiogram within 30 days prior to randomization.
• Symptomatic heart failure in NYHA class III or IV.
• Able to comply with scheduled visits in cardiac out-patient clinic.
• Able to tolerate study procedures, including bone marrow aspiration, cardiac CT, metabolic stress test,6 minute walk test.
• Males and females, 18-86 years of age.
• Life expectancy of 6 months or more in the opinion of the 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).
• 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.
• Stable, standard medical therapy for DCM for at least 1 month with NO new medications to treat the disease introduced in the last 3 months. Standard medical therapy includes: Placement of AICD unless contraindicated (refusal of AICD not considered valid contraindication), use of ACE inhibitors and/or AT-1 receptor blockers as well as loop diuretics unless contraindicated and, depending on the type of heart failure associated with the disease, standard therapy may also include use of vasodilators, beta blockers, digoxin, and aldosterone or other medications.
• Pre-existing conditions are adequately controlled in the opinion of the investigator.
• Fertile patients must agree to use an appropriate form of contraception while participating in the study.

You may not qualify if:

• Severe primary valvular heart disease including, but not limited to, aortic valve stenosis and insufficiency.
• Known history of COPD defined as Gold stage IIB (FEV1/FVC\<70% with 30%\</=FEV1\<50% predicted, with or without chronic symptoms of cough, sputum production, dyspnea) or more severe or restrictive pulmonary disease.
• Known history of primary pulmonary hypertension.
• VAD implantation.
• Myocardial infarction within 4 weeks prior to randomization.
• History of life-threatening ventricular arrhythmia, except if an AICD is implanted.
• Unstable angina, characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration.
• Patients at high risk for complications due to injection procedure (e.g. patients who have severe peripheral atherosclerotic disease that does not allow advancement of the catheter; patients who have a prosthetic aortic or mitral valve; patients who have a LV thrombus or aneurysm; patients who have an aortic dissection or aneurysm, etc.).
• Patients w/poorly controlled diabetes mellitus (HbAlc\>9.0%).
• Patients receiving treatment with hematopoietic growth factors (e.g. EPO, G-CSF).
• Patients who require uninterruptible anticoagulation therapy (e.g. warfarin)that cannot be stopped for 72 hours prior to bone marrow aspiration and intramyocardial injections; OR patients receiving anti-platelet therapy (e.g. clopidogrel) that cannot be stopped for 7 days prior to bone marrow aspiration and transendocardial injections, unless contraindicated.
• Known cancer and undergoing treatment including chemotherapy and radiation.
• Patients requiring continuous, systemic, high dose corticosteroid therapy (more than 7.5 mg/day) within 1 month before aspiration or 6 months after injection procedure.
• End stage renal disease requiring dialysis.
• Patients pregnant or lactating; positive for hCG

Sponsors & Collaborators

• Vericel Corporation: lead

Study Sites (3)

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

University Hospitals, Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Utah

Salt Lake City, Utah, 84112, 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

Condition Hierarchy (Ancestors)

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

Study Officials

• Timothy Henry, MD

  Minneapolis Heart Institute Foundation

  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: November 25, 2009
• First Posted: November 26, 2009
• Study Start: December 1, 2009
• Primary Completion: January 11, 2012
• Study Completion: December 5, 2013
• Last Updated: May 27, 2021

Record last verified: 2021-05

Locations

US (3)