AzTrials
AzTrials

Ischemic Dilated Cardiomyopathy (IDCM)Phase 2ixCELLDCMNCT01670981

An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM)

A Phase 2 study testing ixmyelocel-T in people with Ischemic Dilated Cardiomyopathy (IDCM), run by Vericel Corporation at 36 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or… Read more about this study

Who is it for?
Ages 30 to 86 years
Conditions the study is for
Ischemic Dilated Cardiomyopathy (IDCM)
What is being tested?
ixmyelocel-T
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
36 sitesin 2 countries
Study dates
20 Feb 2013to 7 Mar 2018
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 30 to 86 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and non-pregnant, non-lactating females;
  • Age 30 to 86 years of age;
  • Diagnosis of ischemic dilated cardiomyopathy;
  • LVEF ≤ 35% by echocardiogram;
  • Symptomatic heart failure in NYHA functional class III or IV;
  • Subject is not a candidate for reasonable revascularization procedures that will produce clinical improvement;
Show all 15Show fewer
  • Subject is receiving appropriate clinical standard of care heart failure therapy, as tolerated and as dictated by a subject's current medical condition, for at least 30 days prior to screening;
  • Must have an automatic implantable cardioverter defibrillator (AICD);
  • Worsening heart failure hospitalization or equivalent within 6 months prior to screening, hospitalization equivalent defined as an unplanned outpatient/emergency department visit for treatment of acute decompensated heart failure; or have an N-terminal prohormone B-type natriuretic peptide (NT-proBNP) ≥2000 pg/mL or BNP ≥400 pg/mL within 30 days of screening (including screening); or have a 6-minute walk test (6MWT) distance of ≤400 meters at screening;
  • Life expectancy of at least 12 months in the opinion of the Investigator;
  • LV wall thickness ≥ 7mm (by echocardiogram) at anticipated target injection area;
  • Hemodynamic stability without IV vasopressors or support devices;
  • Given medical history and concurrent medication, subject is an acceptable candidate for bone marrow aspiration and cardiac catheterization and transendocardial injection procedures in the opinion of the Investigator;
  • Willing and able to comply scheduled visits and tolerate study procedures.
  • Voluntarily provide a personally-signed and dated informed consent.

Who cannot join

  • Disease-specific:
  • Severe primary valvular heart disease including, but not limited to, aortic valve stenosis and insufficiency;
  • VAD implantation, heart transplantation, cardiomyoplasty, left ventricular reduction surgery, or cardiac shunt implantation;
  • Planned heart failure-related device interventions (e.g., VAD implantation, initial cardiac resynchronization therapy) or planned cardiac procedures (e.g., heart transplant, cardiomyoplasty, valvular repair);
  • Current arrhythmias that would prohibit accurate NOGA® electromechanical mapping and NOGA®-guided injections;
  • LV thrombus (as documented on echocardiography or LV angiography);
Show all 33Show fewer
  • Myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening;
  • Percutaneous coronary intervention, valvuloplasty, cardiac surgery, and other major cardiac procedure within 30 days prior to screening;
  • In the opinion of the Investigator, the subject's left ventricular wall is unsuitable for transendocardial injections (due to thickness or other reasons).
  • Medical History:
  • Stroke or transient ischemic attack (TIA) within 3 months of screening;
  • Hemoglobin A1c (HbA1c) ≥ 9% at screening;
  • Diabetic subjects with uncontrolled or untreated proliferative retinopathy as determined by dilated eye exam administered by a qualified eye care professional as per American Diabetes Association guidelines;
  • Blood clotting disorder not caused by medication (e.g., thrombophilia);
  • Active malignancy (non-basal cell) requiring surgery, chemotherapy, and/or radiation in the past 12 months;
  • Drug or alcohol abuse that would interfere with the subject's compliance with study procedures;
  • Allergies to any equine, porcine, or bovine products;
  • Body mass index (BMI) ≥ 40 kg/m2 at screening;
  • Established chronic kidney disease (CKD) requiring dialysis (Stage 5); estimated creatinine clearance < 15 mL/min at screening;
  • Subject has allergy or is unable to tolerate cardiac imaging contrast agents; also the inability to get a good quality echocardiogram image at screening (as determined by the imaging core lab).
  • Laboratory Parameters:
  • Abnormal laboratory values (performed at central lab) at screening:
  • Platelets < 50,000 μL;
  • Hemoglobin < 9.0 g/dL;
  • Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 3 times the upper limit of normal (ULN);
  • Human immunodeficiency virus 1 (HIV 1), HIV 2, or syphilis positive (rapid plasma reagin [RPR]);
  • Active hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies;
  • NOTE: Additional lab tests may be performed per local requirements including but not limited to: hepatitis B core antibody, human T lymphotropic virus I/II.
  • Exclusionary Procedures, Devices, or Medication:
  • Subjects receiving anti-angiogenic drugs (e.g., anti-vascular endothelial growth factor [VEGF]);
  • Chronic exposure to cytotoxic therapy for oncologic or chronic non-oncologic reasons in the prior 3 months or expected requirement over the course of the study;
  • Concurrent participation in another interventional clinical trial or receiving experimental intervention within 30 days of screening or having previously been exposed to Aastrom's ixmyelocel T product or previously received allogeneic cell therapy, autologous cell therapy cultured with animal proteins.
  • In the opinion of the Investigator, the subject is unsuitable for cellular therapy or has a food/drug allergy, surgical or medical condition, clinically significant psychiatric disorders, poor nutritional status, or lab abnormality requiring further medical evaluation that may interfere with the investigational product, interfere with the study results' interpretation, interfere with the subject's ability to complete the study or compromise the subject's safety.

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States34 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Georgia Regents University

    Augusta, Georgia, 30912

  • Cardiology, P.C. & Center for Therapeutic Angiogenesis

    Birmingham, Alabama, 35211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital, Division of Cardiology

    Boston, Massachusetts, 02114

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Carl and Edyth Linder Center for Research & Education at The Christ Hospital

    Cincinnati, Ohio, 45219

  • University Hospitals - Case Medical Center

    Cleveland, Ohio, 44106

  • Soltero Cardiovascular Research Center

    Dallas, Texas, 75226

  • Cardiology Research Associates

    Daytona Beach, Florida, 32117

  • University of Florida - Division of Cardiology

    Gainesville, Florida, 32610

  • Stern Cardiovascular Foundation, Inc.

    Germantown, Tennessee, 38138

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • Methodist DeBakey Heart and Vascular Center

    Houston, Texas, 77030

  • Mayo Clinic Florida (Jacksonville)

    Jacksonville, Florida, 32224

  • Scripps Clinic

    La Jolla, California, 92037

  • UCSD Medical Center

    La Jolla, California, 92037

  • Cedars-Sinai Heart and Lung Institute

    Los Angeles, California, 90048

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095

  • University of Wisconsin-Madison Cardiovascular Medicine

    Madison, Wisconsin, 53792

  • University of Miami - Miller School of Medicine

    Miami, Florida, 33136

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Newark Beth Israel Hospital

    Newark, New Jersey, 07112

  • St. John's Regional Medical Center

    Oxnard, California, 93030

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • UPMC Cardiovascular Institute

    Pittsburgh, Pennsylvania, 15213

  • Veterans Administration Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Michigan CardioVascular Institute

    Saginaw, Michigan, 48602

  • University of Utah Health Services Center

    Salt Lake City, Utah, 84132

  • Swedish Medical Center - Cherry Hill Professional Building

    Seattle, Washington, 98122

  • Stanford University

    Stanford, California, 94305

Other trials in United States

Canada2 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 287

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

Other trials in Canada

About this study

Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of Transendocardial Injection of Ixmyelocel-T in Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM).

This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.

Read the detailed description

The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average per patient number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure, over the 12 months following administration of investigational product (IP).

Being tested
ixmyelocel-T, Placebo
Keywords
Ischemic dilated cardiomyopathy, Heart failure, ixCELL, ixCELL DCM, IDCM, DCM, stem cells, MSC, cell therapy
Medical subject headings
Heart Failure

What participants receive

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

  • ixmyelocel-TBiological

    12-20 transendocardial injections of 0.4 mL of ixmyelocel-T per injection into the left ventricle.

  • PlaceboOther

    12-20 transendocardial injections of 0.4 mL of vehicle control per injection into the left ventricle.

Study groups in NCT01670981
Study groupRoleWhat they receive
ixmyelocel-TExperimentalIxmyelocel-T delivered by catheter-based intramyocardial injection procedure.
Receives: Biological: ixmyelocel-T
PlaceboPlacebo comparatorPlacebo delivered by catheter-based intramyocardial injection procedure.
Receives: Other: Placebo

What is being measured

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

  1. Average number of clinical events over 12 months post-treatment.

    The primary endpoint will assess the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average number of events per patient over 12 months post-treatment in each treatment arm (total number events in each arm/total number of patients in each arm). The events include: all-cause deaths, cardiovascular hospitalizations, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure. The clinical events used in this endpoint will be adjudicated by an independent clinical endpoint committee who are blinded to treatment.

    Measured: 12 Months

Secondary outcomes (7)

  1. The win ratio of the hierarchical occurrence of all-cause deaths/left ventricular assist device (LVAD) implant/heart transplant, cardiovascular hospitalizations, and unplanned outpatient and ED interventions to treat ADHF

    This is a composite end point. This endpoint will be primarily assessed excluding events considered to be related to administration of IP. An analysis including IP administration-related events will also be conducted as part of the sensitivity analyses.

    Measured: 12 Months

  2. Change from baseline to 12 months post-treatment in 6-minute walk test.

    A secondary objective will be to evaluate the changes from baseline to 12 months post-treatment in the distance walked as measured by the 6-minute walk test.

    Measured: 12 Months

  3. Change from baseline to 12 months post-treatment in left ventricular function as evaluated by echocardiography.

    A secondary objective will be to evaluate the change in left ventricular function as measured by echocardiography for left ventricular ejection fraction (LVEF).

    Measured: 12 Months

  4. Change from baseline to 12 months post-treatment in quality of life.

    A secondary objective will be to evaluate the change in quality of life (total score) in patients treated with ixmyelocel-T compared to placebo using the Minnesota Living with Heart Failure Questionnaire.

    Measured: 12 Months

  5. Change from baseline to 12 months post-treatment in NYHA Classification.

    A secondary objective will be to evaluate the change from baseline to Month 12 in NYHA Classification in patients treated with ixmyelocel-T compared to placebo.

    Measured: 12 Months

  6. Percent of patients with adverse events.

    A secondary objective will be to evaluate the overall safety and tolerability of ixmyelocel-T versus placebo in patients with DCM from time of aspiration through 12 months post-treatment/follow-up by % of patients with adverse events.

    Measured: 12 Months

  7. Percent of patients with major adverse cardiac events (MACE).

    A secondary objective will be to evaluate the overall safety and tolerability of ixmyelocel-T versus placebo in patients with DCM by the percentage of patients who experience MACE events. MACE events include: unstable angina requiring hospitalization, myocardial infarction, stroke, worsening heart failure requiring hospitalization, VAD implantation, heart transplant, resuscitated sudden death, and cardiovascular death.

    Measured: 12 Months

Timeline

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

  1. First posted23 Aug 2012 (estimated)
  2. Study start20 Feb 2013
  3. Primary completion1 Feb 2016
  4. Study completion7 Mar 2018

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01670981
Sponsor's protocol ID
ABI 55-1202-1
Acronym
ixCELLDCM
Status last verified
May 2021
First submitted
20 Aug 2012
Last updated
27 May 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Patel AN, Henry TD, Quyyumi AA, Schaer GL, Anderson RD, Toma C, East C, Remmers AE, Goodrich J, Desai AS, Recker D, DeMaria A; ixCELL-DCM Investigators. Ixmyelocel-T for patients with ischaemic heart failure: a prospective randomised double-blind trial. Lancet. 2016 Jun 11;387(10036):2412-21. doi: 10.1016/S0140-6736(16)30137-4. Epub 2016 Apr 5.

    PubMed 27059887

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ixmyelocel-T in people with Ischemic Dilated Cardiomyopathy (IDCM), run by Vericel Corporation at 36 sites in 2 countries.

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 15 inclusion and 33 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 36 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?

Average number of clinical events over 12 months post-treatment. (time frame: 12 Months). 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 NCT01670981, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in