Ischemic CardiomyopathyPhase 1NCT01721902
Stem Cell Implantation in Patients Undergoing CABG
A Phase 1 study testing Autologous CD133+ Bone Marrow Stem Cells and Carrier Solution in people with Ischemic Cardiomyopathy and Coronary Artery Disease, run by Miltenyi Biotec, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to demonstrate the feasibility and safety of intra-operative, intra-myocardial injection of autologous CD133 positive bone marrow cells at the time of coronary artery bypass graft (CABG) surgery in patients with chronic ischemic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cardiomyopathy, Coronary Artery Disease
- What is being tested?
- Autologous CD133+ Bone Marrow Stem Cells and Carrier Solution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2013
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Patients with ischemic heart disease manifested by Canadian class II or greater angina and/or New York Heart Association class II, III or IV exercise intolerance AND who have undergone diagnostic coronary angiography demonstrating at least 70% diameter narrowing of at least 2 major coronary arteries or branches or at least 50% diameter narrowing of the left main coronary artery.
- Left ventricular systolic dysfunction evaluated by echocardiography or LV angiography (LV ejection fraction less than or equal to 49%).
- No contraindications or exclusions (see below)
- Willingness to participate and ability to provide informed consent
Who cannot join
- Contraindications to magnetic resonance imaging .
- Need for emergent revascularization.
- Need for concomitant surgical procedure at the time of CABG (e.g. valve repair or replacement, aneurysm resection, etc.).
- Hemodynamically unstable patients.
- Patients with confirmed transmural myocardial infarction within 4 weeks, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes.
- Prior CABG surgery.
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- Stroke within 1 month prior to planned CABG.
- Diagnosed with human immunodeficiency virus (HIV) or any other immune disorder or immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.)
- Organ dysfunction
- Contra-indication for bone marrow aspiration (Thrombocytopenia < 50.000 mm3, INR > 2.0, use of antiplatelet agents other than aspirin).
- Hemoglobin less than 8g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3
- Active infection
- Myelodysplastic syndrome (MDS)
- Significant cognitive impairment
- Any condition associated with a life expectancy of less than 6 months
- Patients known allergic reaction or contraindication to any of the component of the CD133+ enriched cells
- Participation in other studies concomitant with this study
- History of severe ventricular tachy-arrythmias
- Inability or unwillingness to provide written informed consent
- Positive serum pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The primary objective of this study is to demonstrate the feasibility and safety of intra-operative, intra-myocardial injection of autologous CD133 positive bone marrow cells at the time of coronary artery bypass graft (CABG) surgery in patients with chronic ischemic cardiomyopathy. Additionally, the feasibility of producing autologous CD133+ bone marrow stem cells will be assessed.
The investigators hypothesize that collection of a sufficient number of CD133+ cells through bone marrow aspiration prior to surgery, with subsequent processing and intra-myocardial injection of high purity cells following completion of CABG, will be feasible without significant adverse clinical consequences.
Read the detailed description
Coronary heart disease (CHD) is the leading cause of death in the U.S. in both men and women and the aging of the population and rising prevalence of diabetes ensure that the number of persons with CHD will continue to increase over the next several decades. Two major factors contributing to adverse outcomes in patients undergoing coronary artery bypass grafting (CABG) surgery are failure to achieve complete revascularization, and residual impairment in left ventricular function.
In the present study, the investigators propose a Phase I randomized double-blind study designed to assess the feasibility and safety of autologous CD133+ cells in patients referred for CABG who have significant regions of viable but non-revascularizable myocardium and/or significant LV systolic dysfunction not likely to improve with conventional coronary revascularization.
Autologous CD133+ bone marrow progenitor cells will be harvested from study subjects at the time of CABG, processed and then injected into patients' myocardium prior to completion of CABG surgery. The test material consists of autologous CD133+ cells. Since intra-myocardial injections per se could stimulate neovascularization, control group patients will receive a placebo injection of carrier solution. Control subjects will thus have an identical procedure to those randomized to autologous CD133+ cell injections.
The three goals of the study are as follows:
- To demonstrate the feasibility and safety of intra-operative, intra-myocardial injection of autologous CD133+ bone marrow cells in adults with chronic ischemic cardiomyopathy associated with impair left ventricular function.
- To assess the effect of autologous CD133+ cell injections on regional myocardial perfusion and function by comparing paired magnet resonance scans obtained prior to CABG and again 6 months post CABG.
- To assess the effect of autologous CD133+ stem cell injections on symptom severity and quality of life at 6 months after CABG surgery.
- Conditions
- Ischemic Cardiomyopathy, Coronary Artery Disease
- Being tested
- Autologous CD133+ Bone Marrow Stem Cells, Carrier Solution
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous CD133+ Bone Marrow Stem CellsDevice
Intra-myocardial injection of 2-3 x 10E6 CD133+ Bone Marrow Stem Cells
Carrier SolutionOther
Intra-myocardial injection of carrier solution
| Study group | Role | What they receive |
|---|---|---|
| Autologous CD133+ Bone Marrow Stem Cells | Active comparator | Intra-myocardial injection of autologous CD133+ cells in suspension. Receives: Device: Autologous CD133+ Bone Marrow Stem Cells |
| Carrier Solution | Placebo comparator | Intra-myocardial inception of carrier solution. Receives: Other: Carrier Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from a Major Adverse Cardiac Event (MACE)
Defined as cardiac death, myocardial infarction (CK/CK-MB over 5 times the upper limit of normal), repeat coronary bypass grafting, or a repeat percutaneous intervention of bypassed coronary artery.
Measured: Six months
Feedom from any major arrhythmias
Defined as sustained ventricular tachycardia or survived sudden death.
Measured: Six months
Secondary outcomes (2)
Regional myocardial perfusion and function assessed by comparing paired magnetic resonance scans, ECHOs and SPECT scans obtained prior to CABG and again at 6 months post CABG.
Measured: 6 months
Symptom severity and quality of life at 6 months after CABG surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startJan 2010
- Primary completionOct 2013
- Study completionDec 2013
Why it stopped: The study was terminiated due the lack of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miltenyi Biotec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi-Ping J Woo, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721902
- Sponsor's protocol ID
- 0801-133
- Other IDs
- 808756
- Status last verified
- Dec 2013
- First submitted
- 1 Oct 2012
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cell Implantation in Patients Undergoing CABG
- ClinicalTrials.gov ID
- NCT01721902
- Acronym / sponsor ID
- 0801-133
- Conditions
- Ischemic Cardiomyopathy, Coronary Artery Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminiated due the lack of recruitment.
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Miltenyi Biotec, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Nov 2012 (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.
The primary objective of this study is to demonstrate the feasibility and safety of intra-operative, intra-myocardial injection of autologous CD133 positive bone marrow cells at the time of coronary artery bypass graft (CABG) surgery in patients with chronic ischemic cardiomyopathy. Additionally, the feasibility of producing autologous CD133+ bone marrow stem cells will be assessed.
The investigators hypothesize that collection of a sufficient number of CD133+ cells through bone marrow aspiration prior to surgery, with subsequent processing and intra-myocardial injection of high purity cells following completion of CABG, will be feasible without significant adverse clinical consequences.
Detailed description
Coronary heart disease (CHD) is the leading cause of death in the U.S. in both men and women and the aging of the population and rising prevalence of diabetes ensure that the number of persons with CHD will continue to increase over the next several decades. Two major factors contributing to adverse outcomes in patients undergoing coronary artery bypass grafting (CABG) surgery are failure to achieve complete revascularization, and residual impairment in left ventricular function.
In the present study, the investigators propose a Phase I randomized double-blind study designed to assess the feasibility and safety of autologous CD133+ cells in patients referred for CABG who have significant regions of viable but non-revascularizable myocardium and/or significant LV systolic dysfunction not likely to improve with conventional coronary revascularization.
Autologous CD133+ bone marrow progenitor cells will be harvested from study subjects at the time of CABG, processed and then injected into patients' myocardium prior to completion of CABG surgery. The test material consists of autologous CD133+ cells. Since intra-myocardial injections per se could stimulate neovascularization, control group patients will receive a placebo injection of carrier solution. Control subjects will thus have an identical procedure to those randomized to autologous CD133+ cell injections.
The three goals of the study are as follows:
- To demonstrate the feasibility and safety of intra-operative, intra-myocardial injection of autologous CD133+ bone marrow cells in adults with chronic ischemic cardiomyopathy associated with impair left ventricular function.
- To assess the effect of autologous CD133+ cell injections on regional myocardial perfusion and function by comparing paired magnet resonance scans obtained prior to CABG and again 6 months post CABG.
- To assess the effect of autologous CD133+ stem cell injections on symptom severity and quality of life at 6 months after CABG surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous CD133+ Bone Marrow Stem Cells | Active comparator | Device: Autologous CD133+ Bone Marrow Stem CellsIntra-myocardial injection of autologous CD133+ cells in suspension. |
| Carrier Solution | Placebo comparator | Other: Carrier SolutionIntra-myocardial inception of carrier solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Patients with ischemic heart disease manifested by Canadian class II or greater angina and/or New York Heart Association class II, III or IV exercise intolerance AND who have undergone diagnostic coronary angiography demonstrating at least 70% diameter narrowing of at least 2 major coronary arteries or branches or at least 50% diameter narrowing of the left main coronary artery.
- Left ventricular systolic dysfunction evaluated by echocardiography or LV angiography (LV ejection fraction less than or equal to 49%).
- No contraindications or exclusions (see below)
- Willingness to participate and ability to provide informed consent
Key exclusion criteria (20 listed)
- Contraindications to magnetic resonance imaging .
- Need for emergent revascularization.
- Need for concomitant surgical procedure at the time of CABG (e.g. valve repair or replacement, aneurysm resection, etc.).
- Hemodynamically unstable patients.
- Patients with confirmed transmural myocardial infarction within 4 weeks, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes.
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 |
|---|---|---|
| Autologous CD133+ Bone Marrow Stem CellsIntra-myocardial injection of 2-3 x 10E6 CD133+ Bone Marrow Stem Cells | Device | Autologous CD133+ Bone Marrow Stem Cells |
| Carrier SolutionIntra-myocardial injection of carrier solution | Other | Carrier Solution |
Primary outcome
Freedom from a Major Adverse Cardiac Event (MACE)
Time frame: Six months
Defined as cardiac death, myocardial infarction (CK/CK-MB over 5 times the upper limit of normal), repeat coronary bypass grafting, or a repeat percutaneous intervention of bypassed coronary artery.
Feedom from any major arrhythmias
Time frame: Six months
Defined as sustained ventricular tachycardia or survived sudden death.
2 secondary outcomes
Regional myocardial perfusion and function assessed by comparing paired magnetic resonance scans, ECHOs and SPECT scans obtained prior to CABG and again at 6 months post CABG.
Time frame: 6 months
Symptom severity and quality of life at 6 months after CABG surgery.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: The study was terminiated due the lack of recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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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.
Yi-Ping J Woo, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous CD133+ Bone Marrow Stem Cells and Carrier Solution in people with Ischemic Cardiomyopathy and Coronary Artery Disease, run by Miltenyi Biotec, Inc. at 1 site 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 5 inclusion and 20 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: stopped early, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: The study was terminiated due the lack of recruitment.). Results are not available in the source record.
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?
Freedom from a Major Adverse Cardiac Event (MACE) (time frame: Six months). The study lists 2 primary outcomes in all. 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 4 Dec 2013.