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Dilated CardiomyopathyPhase 2NCT00765518

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

A Phase 2 study testing Ixmyelocel-T in people with Dilated Cardiomyopathy, run by Vericel Corporation at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 86 years
Conditions the study is for
Dilated Cardiomyopathy
What is being tested?
Ixmyelocel-T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesUnited States
Study dates
Sep 2008to 5 Sep 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 86 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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
  • Known allergies to protein products (horse or bovine serum, or porcine trypsin)
  • Body Mass Index 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 time of screening
  • In the opinion of the investigator, patient is unsuitable for cellular therapy
  • Patients receiving anti-angiogenic drugs

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Cleveland Clinic Heart and Vascular Institute

    Cleveland, Ohio, 44195

  • Baylor University Medical Center

    Dallas, Texas, 75226

  • Methodist DeBakey Heart & Vascular Center

    Houston, Texas, 77030

  • The University of Utah School of Medicine

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Ixmyelocel-T, Standard of Care
Keywords
Ischemic Dilated Cardiomyopathy, Non-Ischemic Dilated Cardiomyopathy, ixmyelocel-T
Medical subject headings
Cardiomyopathy, Dilated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ixmyelocel-TBiological

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

  • Standard of CareOther

    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.

Study groups in NCT00765518
Study groupRoleWhat they receive
Ixmyelocel-TExperimentalThe treatment arm of the study will receive injections of the study cellular product.
Receives: Biological: Ixmyelocel-T
Standard of CareOtherStandard of care therapy only.
Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completion5 Sep 2012
  4. Study completion5 Sep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00765518
Sponsor's protocol ID
ABI-55-0712-1
Status last verified
May 2021
First submitted
2 Oct 2008
Last updated
27 May 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25142002

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixmyelocel-T in people with Dilated Cardiomyopathy, run by Vericel Corporation at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety will be assessed by: post-procedure assessments, physical exam, vital signs, laboratory tests, and adverse events including MACE (Major Adverse Cardiac Event) occurrences. (time frame: Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00765518, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.

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