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

Learn more about:
Related Clinical Trial
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease CorCinch-HF Repair System in Patients Who Present With Symptomatic Non-Ischemic or Ischemic Dilated Cardiomyopathy Early Administration of Ivabradine in Children With Heart Failure Metabolomics and Microbiomics in Cardiovascular Diseases Mannheim TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies Risk Stratification in Children and Adolescents With Primary Cardiomyopathy Pediatric Cardiomyopathy Mutation Analysis German Centre for Cardiovascular Research Cardiomyopathy Register Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO An Integrative-“Omics” Study of Cardiomyopathy Patients for Diagnosis and Prognosis in China Metabolomic Study of All-age Cardiomyopathy Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry The Genetics of Cardiomyopathy and Heart Failure Inflammation, Cardiac Sympathetic Innervation, and Arrhythmic Sudden Death Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe Randomized Trial of Interventions to Improve Warfarin Adherence Testing Strategies to Improving Warfarin Adherence Prospective Study Looking at Quality of Life Measures in Non-ischaemic Cardiomyopathy After Mitral Valve Repair Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study The Cardiovascular Genetic and Therapeutic Implications of Muscular Dystrophy A Randomized Trial of Carvedilol in Chronic Chagas Cardiomyopathy Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure (CHF) Echo Assessment of Intraventricular Dyssynchrony Brain Function and Perfusion in Patients With Heart Failure Molecular and Imaging Studies of Cardiovascular Health and Disease Genotype-Phenotype Associations in Pediatric Cardiomyopathy (PCM GENES) Optimizing Left Ventricular Lead To Improve Cardiac Output Using Ripple Mapping to Guide Substrate Ablation of Scar Related Ventricular Tachycardia. Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491 Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure Harefield Recovery Protocol Study for Patients With Refractory Chronic Heart Failure ACC – Atrial Contribution to CRT Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie) Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium Efficacy of Implantable Cardioverter Defibrillator in Patients With Non-ischemic Systolic Heart Failure on Mortality Cardiac Biomarkers in Pediatric Cardiomyopathy (PCM Biomarkers) Arrhythmia Prediction Trial Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants A Single Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of MYK-491 Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study. Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy. A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure Effect of Rosuvastatin on Left Ventricular Remodeling Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy Assessment of Right Ventricular Function in Advanced Heart Failure An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001 Optimized Biventricular Pacing Allograft Recipients BiPAP for Cardiomyopathy With Central Sleep Apnea Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis Effect of Aldosterone on Energy Starvation in Heart Failure Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside Therapy With Verapamil or Carvedilol in Chronic Heart Failure Effect of Beta-blockers on Structural Remodeling and Gene Expression in the Failing Human Heart Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure Danish ICD Study in Patients With Dilated Cardiomyopathy Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy DCM Precision Medicine Study A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure The Genetics of Dilated Cardiomyopathy: A Quebec-Based Study Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy A Trial of Autologous Bone Marrow Derived Stem Cells in Paediatric Heart Failure Resynchronization Therapy in Young Patients With and Without CHD Withdrawal of Medication in Recovered DCM Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery PUFAs and Left Ventricular Function in Heart Failure 18F-deoxyglucose (FDG) PET-CMD Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM) Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy Combination of Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy Mesenchymal Stem Cells for Idiopathic Dilated Cardiomyopathy Continues Positive Airway Pressure Treatment for Patients With Dilated Cardiomyopathy and Obstructive Sleep Apnea Pathophysiology of Dilated Cardiomyopathy Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy Clinical and Genetic Examinations of Dilated Cardiomyopathy Simvastatin Therapy in Patients With Dilated Cardiomyopathy. Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy Safety and Efficacy Study of Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy Respiratory Muscles Training in Patients With Dilated Cardiomyopathy Myocardial Metabolism in Patients With Dilated Cardiomyopathy Intracoronary Autologous Mesenchymal Stem Cells Implantation in Patients With Ischemic Dilated Cardiomyopathy Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy Multicenter Study of Immunoadsorption in Dilated Cardiomyopathy Cell Therapy In Dilated Cardiomyopathy Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy Intracoronary Infusion of Autologous Bone Marrow Cells for Treatment of Idiopathic Dilated Cardiomyopathy Infusion Intracoronary of Mononuclear Autologous Adult no Expanded Stem Cells of Bone Marrow on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure. Nesiritide – Dilated Cardiomyopathy A Study of Impact of Anemia on Morbidity and Mortality in Children With Dilated Cardiomyopathy Defining the Role of Insulin Resistance in ‘Idiopathic’ Dilated Cardiomyopathy Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM) Use of Ixmyelocel-T (Formerly Catheter-based Cardiac Repair Cell [CRC]) Treatment in Patients With Heart Failure Due to Dilated Cardiomyopathy A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy Honey in Idiopathic Dilated Cardiomyopathy A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

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

Interventional


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)

Condition

Dilated Cardiomyopathy

Intervention

Ixmyelocel-T

Study Arms / Comparison Groups

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

Publications

* 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

Biological

Estimated Enrollment

22

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.
      

Gender

All

Ages

18 Years - 86 Years

Accepts Healthy Volunteers

No

Contacts

Timothy Henry, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01020968

Organization ID

ABI-55-0811-1


Responsible Party

Sponsor

Study Sponsor

Vericel Corporation


Study Sponsor

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


Verification Date

May 2020