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

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Brief Title

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

Official Title

Catheter-based Transendocardial Delivery of Autologous Bone Marrow-Derived Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy

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).

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 (Hunt SA; et al., 2005). 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.

      Aastrom is targeting a subset of heart failure patient population, namely those diagnosed
      with dilated cardiomyopathy. The World Health Organization (WHO) defines dilated
      cardiomyopathy (DCM) as a cardiac condition wherein a ventricular chamber exhibits increased
      diastolic and systolic volume and a low (<40%) ejection fraction (Manolio TA; et al., 1992;
      Towbin JA; et al., 2006). DCM is reported to affect 108,000 to 150,000 patients in the United
      States (Richardson P; et al., 1996; Towbin JA; et al., 2006).

      This study is a prospective, stratified, randomized, open-label, controlled, multi-center
      study to assess the safety profile and the efficacy of CRCs administered via catheter in
      treating patients with DCM. Two strata will be used: ischemic (IDCM) and non-ischemic
      (NIDCM). Within each stratum, patients will be randomized to receive either CRC treatment or
      control in a 2:1 ratio (8 patients per CRC treatment group and 4 patients per control group).
      It will enroll a total of 24 patients at 2 sites in the U.S.

Study Phase

Phase 2

Study Type


Primary Outcome

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)

Secondary Outcome

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


Dilated Cardiomyopathy



Study Arms / Comparison Groups

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


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

December 2009

Completion Date

December 2013

Primary Completion Date

January 2013

Eligibility Criteria

        Inclusion Criteria:

          -  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 /= 3,000/microgram, Absolute neutrophil
             count >/= 1,500/microgram, Platelets >/= 140,000/microgram, AST(SGOT)/ALT (SGPT) 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

          -  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 w/in 6 months of screening.

          -  Known allergies to protein products (horse or bovine serum, or porcine trypsin) used
             in the ex-vivo cell production process.

          -  BMI 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 the time of screening.

          -  Patient determined unsuitable for cellular therapy, in the opinion of the investigator
             or sponsor.

          -  Patients receiving anti-angiogenic drugs (e.g. anti-VEGF).

          -  Known allergy or sensitivity to contrast agents used in imaging procedures.

          -  Minimum LV wall thickness of less than 6mm as determined by ECHO.




18 Years - 86 Years

Accepts Healthy Volunteers



Timothy Henry, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Vericel Corporation

Study Sponsor

Timothy Henry, MD, Principal Investigator, Minneapolis Heart Institute Foundation

Verification Date

May 2020