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

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Brief Title

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

Official Title

Intramyocardial Delivery of Autologous Bone Marrow Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy

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).
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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

Condition

Dilated Cardiomyopathy

Intervention

Ixmyelocel-T

Study Arms / Comparison Groups

 Ixmyelocel-T
Description:  The treatment arm of the study will receive 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

40

Start Date

September 2008

Completion Date

February 2012

Primary Completion Date

February 2011

Eligibility 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 /= 3,000/microgram, Absolute neutrophil
             count >/= 1,500/microgram, Platelets >/= 140,000/microgram, AST (SGOT)/ALT (SGPT)  50%
             predicted)

          -  Controlled blood pressure (systolic blood pressure 					

Gender

All

Ages

18 Years - 86 Years

Accepts Healthy Volunteers

No

Contacts

Amit Patel, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00765518

Organization ID

ABI-55-0712-1


Responsible Party

Sponsor

Study Sponsor

Vericel Corporation


Study Sponsor

Amit Patel, MD, Principal Investigator, University of Utah


Verification Date

October 2019