Dilated CardiomyopathyPhase 2NCT01020968
Use of Ixmyelocel-T (Formerly Catheter-based Cardiac Repair Cell [CRC]) Treatment in Patients With Heart Failure Due to Dilated Cardiomyopathy
A Phase 2 study testing Ixmyelocel-T in people with Dilated Cardiomyopathy, run by Vericel Corporation at 3 sites in United States.
Trial 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). 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?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2009to 5 Dec 2013
- 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 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 </= 30% by echocardiogram within 30 days prior to randomization.
- Symptomatic heart failure in NYHA class III or IV.
- Able to comply with scheduled visits in cardiac out-patient clinic.
- Able to tolerate study procedures, including bone marrow aspiration, cardiac CT, metabolic stress test,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 the 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).
- 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.
- Stable, standard medical therapy for DCM for at least 1 month with NO new medications to treat the disease introduced in the last 3 months. Standard medical therapy includes: Placement of AICD unless contraindicated (refusal of AICD not considered valid contraindication), use of ACE inhibitors and/or AT-1 receptor blockers as well as loop diuretics unless contraindicated and, depending on the type of heart failure associated with the disease, standard therapy may also include use of vasodilators, beta blockers, digoxin, and aldosterone or other medications.
- Pre-existing conditions are adequately controlled in the opinion of the investigator.
- Fertile patients must agree to use an appropriate form of contraception while participating in the study.
Who cannot join
- Severe primary valvular heart disease including, but not limited to, aortic valve stenosis and insufficiency.
- Known history of COPD defined as Gold stage IIB (FEV1/FVC<70% with 30%</=FEV1<50% predicted, with or without chronic symptoms of cough, sputum production, dyspnea) or more severe or restrictive pulmonary disease.
- Known history of primary pulmonary hypertension.
- VAD implantation.
- Myocardial infarction within 4 weeks prior to randomization.
- History of life-threatening ventricular arrhythmia, except if an AICD is implanted.
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- Unstable angina, characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration.
- Patients at high risk for complications due to injection procedure (e.g. patients who have severe peripheral atherosclerotic disease that does not allow advancement of the catheter; patients who have a prosthetic aortic or mitral valve; patients who have a LV thrombus or aneurysm; patients who have an aortic dissection or aneurysm, etc.).
- Patients w/poorly controlled diabetes mellitus (HbAlc>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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospitals, Case Western Reserve University
Cleveland, Ohio, 44106
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Catheter-based Transendocardial Delivery of Autologous Bone Marrow-Derived Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy
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).
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 (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.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- Ixmyelocel-T, Vehicle Control
- 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 catheter-based injection to the endocardial surface of the left ventricle.
Vehicle ControlOther
will receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control into the left ventricle.
| Study group | Role | What they receive |
|---|---|---|
| Ixmyelocel-T | Experimental | The treatment arm of the study will receive catheter-based injections of the study cellular product. Receives: Biological: Ixmyelocel-T |
| Vehicle Control | Placebo comparator | will receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control. Receives: Other: Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Secondary outcomes (12)
Left ventricular ejection fraction (LVEF) (As determined by Echo, Cardiac CT and SPECT)
Measured: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
Change in LV and RV dimensions and in LV volumes (As determined by Echo, Cardiac CT and SPECT)
Measured: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
Wall Motion Score Index (WMSI) (As determined by Echo, Cardiac CT and SPECT)
Measured: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
Assessment of myocardial perfusion in ischemic patient cohort, only (As determined by SPECT)
Measured: Baseline and Month 3
Exercise tolerance (6 minute walk test)
Measured: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Heart failure status (As determined by New York Heart Association (NYHA) heart failure status (NYHA) class and Brain Natriuretic Peptide [BNP])
Measured: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Angina status (As determined by Canadian Cardiovascular Society (CCS) classification and Troponin I Levels)
Measured: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Quality of life (As determined by Minnesota Living with Heart Failure Questionnaire [MLHFQ])
Measured: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Pulmonary function (As determined by metabolic stress test)
Measured: Baseline, Month 6 and Month 12
Device implantation, transplantation and positive inotrope use (As determined by incidence rates)
Measured: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
AICD firing rate
Measured: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Changes in medication for heart failure
Measured: Outcome measures will generally be assessed at Baseline, 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.
- First posted26 Nov 2009 (estimated)
- Study startDec 2009
- Primary completion11 Jan 2012
- Study completion5 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vericel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Henry, MD, Principal investigator, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020968
- Sponsor's protocol ID
- ABI-55-0811-1
- Status last verified
- May 2021
- First submitted
- 25 Nov 2009
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter-based Transendocardial Delivery of Autologous Bone Marrow-Derived Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01020968
- Acronym / sponsor ID
- ABI-55-0811-1
- Conditions
- Dilated Cardiomyopathy
- Keywords
- Ischemic Dilated Cardiomyopathy, Non-Ischemic Dilated Cardiomyopathy, ixmyelocel-T
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Vericel CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- 11 Jan 2012 (actual)
- Study completion
- 5 Dec 2013 (actual)
- First posted
- 26 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ixmyelocel-T | Experimental | Biological: Ixmyelocel-TThe treatment arm of the study will receive catheter-based injections of the study cellular product. |
| Vehicle Control | Placebo comparator | Other: Vehicle Controlwill receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control. |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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 </= 30% by echocardiogram within 30 days prior to randomization.
- Symptomatic heart failure in NYHA class III or IV.
- Able to comply with scheduled visits in cardiac out-patient clinic.
Key exclusion criteria (25 listed)
- Severe primary valvular heart disease including, but not limited to, aortic valve stenosis and insufficiency.
- Known history of COPD defined as Gold stage IIB (FEV1/FVC<70% with 30%</=FEV1<50% predicted, with or without chronic symptoms of cough, sputum production, dyspnea) or more severe or restrictive pulmonary disease.
- Known history of primary pulmonary hypertension.
- VAD implantation.
- Myocardial infarction within 4 weeks prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ixmyelocel-TCRCs will be administered via catheter-based injection to the endocardial surface of the left ventricle. | Biological | Ixmyelocel-T |
| Vehicle Controlwill receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control into the left ventricle. | Other | Vehicle Control |
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)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
12 secondary outcomes
Left ventricular ejection fraction (LVEF) (As determined by Echo, Cardiac CT and SPECT)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
Change in LV and RV dimensions and in LV volumes (As determined by Echo, Cardiac CT and SPECT)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
Wall Motion Score Index (WMSI) (As determined by Echo, Cardiac CT and SPECT)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12. CT and SPECT are only assessed at Baseline and Month 6.
Assessment of myocardial perfusion in ischemic patient cohort, only (As determined by SPECT)
Time frame: Baseline and Month 3
Exercise tolerance (6 minute walk test)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Heart failure status (As determined by New York Heart Association (NYHA) heart failure status (NYHA) class and Brain Natriuretic Peptide [BNP])
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Angina status (As determined by Canadian Cardiovascular Society (CCS) classification and Troponin I Levels)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Quality of life (As determined by Minnesota Living with Heart Failure Questionnaire [MLHFQ])
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Pulmonary function (As determined by metabolic stress test)
Time frame: Baseline, Month 6 and Month 12
Device implantation, transplantation and positive inotrope use (As determined by incidence rates)
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
AICD firing rate
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Changes in medication for heart failure
Time frame: Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 25142002Henry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Henry, MD principal investigator
Minneapolis Heart Institute Foundation
3 sites in 1 country: see every site and its status.
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 3 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 25 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 3 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. 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?
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) (time frame: Outcome measures will generally be assessed at Baseline, 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 NCT01020968, 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.