Heart FailurePhase 2NCT00721045
A Phase II Dose-escalation Study to Assess the Feasibility and Safety of Transendocardial Delivery of Three Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs)in Subjects With Heart Failure
A Phase 2 study testing Mesenchymal Precursor Cells (MPCs) and standard-of-care treatment with mock mapping and injection procedures. in people with Heart Failure, run by Mesoblast, Ltd. at 6 sites in United States.
Trial summary
This is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in subjects who have cardiomyopathy of both ischemic and idiopathic etiology. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Mesenchymal Precursor Cells (MPCs) and standard-of-care treatment with mock mapping and injection procedures.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2008to Jul 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA ≥ 2.
- Age >20 and <80.
- Cardiomyopathy of ischemic or idiopathic etiology.
- Subject is not a candidate for either percutaneous intervention or cardiac surgery as determined by both an interventional cardiologist and a cardiac surgeon.
- LVEF (Left ventricular ejection fraction) < 40% via 2-D Echocardiogram within 28 days of study procedure.
- On stable maximal, tolerable dosages of heart failure therapies including betablockers,ace inhibitors and/or diuretics with no interruption or change in medical therapy for at least 28 days prior to study enrollment.
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- Left Ventricle wall thickness ≥ 8mm at target site by echo within 28 days of study procedure.
- If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
- Willing and able to understand, sign, and date the Informed Consent Form (ICF).
- Must be willing to return for required follow-up visits.
- Must be able to follow postoperative management program.
Who cannot join
- Acute Myocardial Infarction in past 30 days.
- Discharge of subject's ICD within 28 days of study procedure.
- Sustained Ventricular Tachycardia as demonstrated by QRS complexes wider than 120 msec, lasting >30 secs, and >100 bpm documented in screening ECG or 24 hour Holter monitoring.
- Unstable angina.
- LV thrombus by echocardiogram or angiogram with 28 days prior to and up to the time of cell injection.
- Aortic stenosis as determined by echocardiography as valve area less than 1 cm2 that prohibits NOGA catheter access to LV.
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- Cardiogenic shock defined as the need for intravenous inotropic support, an intraaortic balloon pump, or mechanical circulatory support at the time of cell injections.
- Chronic AF or AF at the time of cell injections.
- Unprotected left main coronary artery disease >50%.
- Ischemic or hemorrhagic stroke as diagnosed by CT/MRI events within the last 3 months prior to enrollment.
- Bleeding diathesis disorder such as abnormal coagulation profile precluding performing of mapping/injection procedure.
- Serum glucose level > 400 mg/dl within 28 days of study procedure.
- Serum glucose level 300 to 400 mg/dl and presence of urine ketones within 28 days of study procedure.
- Creatinine level ≥ 2.5 mg/dL within 28 days of study procedure.
- Hematocrit ≤ 32% within 28 days of study procedure.
- White Blood Cell count > 12 x 106/mm3 within 28 days of study procedure.
- Platelet count ≤100 x106/mm3 within 28 days of study procedure.
- Total bilirubin >3 mg/dL, albumin <2.8 g/dL, aspartate aminotransferase (AST) ≥ 2.5x the upper limit of normal, gamma glutamyltranspeptidase (GGT) ≥ 1.5x the upper limit of normal within 28 days of study procedure.
- Presence of ≥ 20% anti-HLA antibody titers and/or having antibody specificities to donor HLA antigens.
- A known hypersensitivity to dimethyl sulfoxide (DMSO), murine and/or bovine products.
- History of cancer prior to screening (excluding basal cell carcinoma).
- Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV).
- Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
- Treatment and/or an uncompleted follow-up treatment of any investigational. therapy within 6 months before procedure and intent to participate in any other investigational drug or cell therapy study during the 3-year follow-up period of this study.
- Active participation in other research therapy for cardiovascular repair/regeneration.
- Prior recipient of stem precursor cell therapy for cardiac repair.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297
Texas Heart Institue
Houston, Texas, 77030
University of California, San Diego
La Jolla, California, 92037-1300
Minneapolis Heart Institute 920 East 28th St, Suite 300
Minneapolis, Minnesota, 55407-1139
UPMC
Pittsburgh, Pennsylvania, 15213
Swedish Heart and Vascular Institute
Seattle, Washington, 98122
About this study
This is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in subjects who have cardiomyopathy of both ischemic and idiopathic etiology.
Read the detailed description
Heart failure subjects recruited will include those who have advanced heart failure NYHA (New York Heart Association) class II to IV and a depressed ejection fraction (EF < 40%). Baseline eligibility testing assessments will be completed within 28 days prior to cell delivery. Efficacy will be explored at 3, 6, and 12 months.
This will be a single-blinded, dose-escalation, cohort study in 60 subjects allocated sequentially to 1 of 3 cohorts A, B, or C. Forty-five subjects will be randomized to receive transendocardial delivery of MPC treatment, and 15 subjects will be randomized to receive standard-of-care treatment without MPC administration. The fifteen subjects randomized to receive standard of care without needle injection will serve as the study's control population and will undergo mock mapping and verbal injection scripts.
- Conditions
- Heart Failure
- Being tested
- Mesenchymal Precursor Cells (MPCs), standard-of-care treatment with mock mapping and injection procedures.
- Keywords
- Heart Failure, Congestive Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Precursor Cells (MPCs)Biological
Also called Revascor
25 M allogeneic MPCs by transendocardial injection and mapping.
Mesenchymal Precursor Cells (MPCs)Biological
Also called Revascor
75 M allogeneic MPCs by transendocardial injection and mapping.
Mesenchymal Precursor Cells (MPCs)Biological
Also called Revascor
150 M allogeneic MPCs by transendocardial injection
standard-of-care treatment with mock mapping and injection procedures.Procedure or surgery
Mock
standard-of-care treatment with mock mapping and injection procedures.Procedure or surgery
Mock
standard-of-care treatment with mock mapping and injection procedures.Procedure or surgery
Mock
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | 15 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection and mapping. Receives: Biological: Mesenchymal Precursor Cells (MPCs) |
| A2 | Sham comparator | 5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. Receives: Procedure: standard-of-care treatment with mock mapping and injection procedures. |
| B1 | Active comparator | 15 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection and mapping. Receives: Biological: Mesenchymal Precursor Cells (MPCs) |
| B2 | Sham comparator | 5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. Receives: Procedure: standard-of-care treatment with mock mapping and injection procedures. |
| C1 | Active comparator | 15 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection and mapping. Receives: Biological: Mesenchymal Precursor Cells (MPCs) |
| C2 | Sham comparator | 5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. Receives: Procedure: standard-of-care treatment with mock mapping and injection procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the feasibility and safety of transendocardial injection using mapping Catheter with the Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic MPCs in subjects with heart failure.
Measured: 3 years
Secondary outcomes (1)
The secondary objectives are to explore functional efficacy for subsequent study design.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2011
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emerson Perin, MD, Principal investigator, Texas Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721045
- Sponsor's protocol ID
- HF-AB002
- Status last verified
- May 2015
- First submitted
- 21 Jul 2008
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Dose-escalation Study to Assess the Feasibility and Safety of Transendocardial Delivery of Three Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs)in Subjects With Heart Failure
- ClinicalTrials.gov ID
- NCT00721045
- Acronym / sponsor ID
- HF-AB002
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Congestive Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Jul 2008 (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 is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in subjects who have cardiomyopathy of both ischemic and idiopathic etiology.
Detailed description
Heart failure subjects recruited will include those who have advanced heart failure NYHA (New York Heart Association) class II to IV and a depressed ejection fraction (EF < 40%). Baseline eligibility testing assessments will be completed within 28 days prior to cell delivery. Efficacy will be explored at 3, 6, and 12 months.
This will be a single-blinded, dose-escalation, cohort study in 60 subjects allocated sequentially to 1 of 3 cohorts A, B, or C. Forty-five subjects will be randomized to receive transendocardial delivery of MPC treatment, and 15 subjects will be randomized to receive standard-of-care treatment without MPC administration. The fifteen subjects randomized to receive standard of care without needle injection will serve as the study's control population and will undergo mock mapping and verbal injection scripts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Biological: Mesenchymal Precursor Cells (MPCs)15 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection and mapping. |
| A2 | Sham comparator | Procedure: standard-of-care treatment with mock mapping and injection procedures.5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. |
| B1 | Active comparator | Biological: Mesenchymal Precursor Cells (MPCs)15 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection and mapping. |
| B2 | Sham comparator | Procedure: standard-of-care treatment with mock mapping and injection procedures.5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. |
| C1 | Active comparator | Biological: Mesenchymal Precursor Cells (MPCs)15 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection and mapping. |
| C2 | Sham comparator | Procedure: standard-of-care treatment with mock mapping and injection procedures.5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- NYHA ≥ 2.
- Age >20 and <80.
- Cardiomyopathy of ischemic or idiopathic etiology.
- Subject is not a candidate for either percutaneous intervention or cardiac surgery as determined by both an interventional cardiologist and a cardiac surgeon.
- LVEF (Left ventricular ejection fraction) < 40% via 2-D Echocardiogram within 28 days of study procedure.
Key exclusion criteria (26 listed)
- Acute Myocardial Infarction in past 30 days.
- Discharge of subject's ICD within 28 days of study procedure.
- Sustained Ventricular Tachycardia as demonstrated by QRS complexes wider than 120 msec, lasting >30 secs, and >100 bpm documented in screening ECG or 24 hour Holter monitoring.
- Unstable angina.
- LV thrombus by echocardiogram or angiogram with 28 days prior to and up to the time of cell injection.
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 |
|---|---|---|
| Mesenchymal Precursor Cells (MPCs)Also: Revascor25 M allogeneic MPCs by transendocardial injection and mapping. | Biological | A1 |
| Mesenchymal Precursor Cells (MPCs)Also: Revascor75 M allogeneic MPCs by transendocardial injection and mapping. | Biological | B1 |
| Mesenchymal Precursor Cells (MPCs)Also: Revascor150 M allogeneic MPCs by transendocardial injection | Biological | C1 |
| standard-of-care treatment with mock mapping and injection procedures.Mock | Procedure or surgery | A2 |
| standard-of-care treatment with mock mapping and injection procedures.Mock | Procedure or surgery | B2 |
| standard-of-care treatment with mock mapping and injection procedures.Mock | Procedure or surgery | C2 |
Primary outcome
The primary objective of this study is to evaluate the feasibility and safety of transendocardial injection using mapping Catheter with the Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic MPCs in subjects with heart failure.
Time frame: 3 years
1 secondary outcome
The secondary objectives are to explore functional efficacy for subsequent study design.
Time frame: 3 years
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 11 Mar 2020.
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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.
Emerson Perin, MD principal investigator
Texas Heart Institute
6 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 Mesenchymal Precursor Cells (MPCs) and standard-of-care treatment with mock mapping and injection procedures. in people with Heart Failure, run by Mesoblast, Ltd. at 6 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 12 inclusion and 26 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The primary objective of this study is to evaluate the feasibility and safety of transendocardial injection using mapping Catheter with the Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic MPCs in subjects with heart failure. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2020.