Myocardial IschemiaPhase 1NCT00620048
Stem Cell Study for Subjects With Congestive Heart Failure
A Phase 1 study testing Intramyocardial injection of autologous CD34-positive cells (stem cells) in people with Myocardial Ischemia and Congestive Heart Failure, run by Losordo, Douglas, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Myocardial Ischemia, Congestive Heart Failure, Cardiovascular Disease
- What is being tested?
- Intramyocardial injection of autologous CD34-positive cells (stem cells)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2011
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 21 to 80 years old (inclusive).
- Subjects with functional class (NYHA) II or III ischemic heart failure.
- Subjects who have attempted "best" cardiac medical therapy including long-acting nitrates, maximal use of beta-adrenergic blocking agents, and angiotensin-converting enzyme (ACE)inhibitors without control of symptoms.
- Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist.
- Subjects must have left ventricular ejection fraction <40% by echocardiography.
- All subjects must have a recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of coronary disease that is not amenable to standard revascularization procedures.
- Have serum B-type Natriuretic Peptide (BNP) level >100 pg/ml.
Who cannot join
- Myocardial infarction (Q wave or non-Q wave defined as CKMB >3 times normal) within 30 days of treatment.
- Successful coronary revascularization procedures within 3 months of study enrollment.
- Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
- NYHA Class IV heart failure and patients with idiopathic or non-ischemic heart failure.
- History of severe aortic stenosis (aortic valve area < 1.0 cm2) or insufficiency (>2+); severe mitral stenosis (mitral valve area <1.5 cm2); or severe mitral insufficiency(>2+).
- Implantation of biventricular pacemaker within 90 days of study treatment.
- Severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (i.e. severe chronic obstructive pulmonary disease, renal failure or cancer).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40%
The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms.
- Being tested
- Intramyocardial injection of autologous CD34-positive cells (stem cells)
- Keywords
- heart, stem Cells, low EF, heart attack, cardiomyopathy, congestive heart failure, cardiovascular disease, Heart Failure, Low Ejection Fraction
- Medical subject headings
- Myocardial Ischemia, Heart Failure, Cardiovascular Diseases, Myocardial Infarction, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramyocardial injection of autologous CD34-positive cells (stem cells)Biological
Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle.
| Study group | Role | What they receive |
|---|---|---|
| Low dose of autologous CD34-positive cells (stem cells) | Experimental | Not described Receives: Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells) |
| High dose of autologous CD34-positive cells (stem cells) | Experimental | Not described Receives: Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of intramyocardial administration of CD34-positive cells
Measured: 6 months
Secondary outcomes (1)
Effects of intramyocardial injections of autologous CD34-positive cells on clinical outcomes.
Clinical outcomes assessed include symptoms, change in health status, myocardial function and exercise duration.
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 posted21 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2011
Why it stopped: Study terminated due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Losordo, Douglas, M.D.
- Responsible party
- Sponsor
- Investigators
- Douglas W. Losordo, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620048
- Sponsor's protocol ID
- STU00002516
- Other IDs
- 11196-03
- Status last verified
- Nov 2011
- First submitted
- 7 Feb 2008
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40%
- ClinicalTrials.gov ID
- NCT00620048
- Acronym / sponsor ID
- STU00002516
- Keywords
- heart, stem Cells, low EF, heart attack, cardiomyopathy, congestive heart failure, cardiovascular disease, Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of funding.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Losordo, Douglas, M.D.
- Study start
- Mar 2008
- Primary completion
- Jan 2011 (actual)
- First posted
- 21 Feb 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.
The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose of autologous CD34-positive cells (stem cells) | Experimental | Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells) |
| High dose of autologous CD34-positive cells (stem cells) | Experimental | Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects 21 to 80 years old (inclusive).
- Subjects with functional class (NYHA) II or III ischemic heart failure.
- Subjects who have attempted "best" cardiac medical therapy including long-acting nitrates, maximal use of beta-adrenergic blocking agents, and angiotensin-converting enzyme (ACE)inhibitors without control of symptoms.
- Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist.
- Subjects must have left ventricular ejection fraction <40% by echocardiography.
Key exclusion criteria (7 listed)
- Myocardial infarction (Q wave or non-Q wave defined as CKMB >3 times normal) within 30 days of treatment.
- Successful coronary revascularization procedures within 3 months of study enrollment.
- Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
- NYHA Class IV heart failure and patients with idiopathic or non-ischemic heart failure.
- History of severe aortic stenosis (aortic valve area < 1.0 cm2) or insufficiency (>2+); severe mitral stenosis (mitral valve area <1.5 cm2); or severe mitral insufficiency(>2+).
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 |
|---|---|---|
| Intramyocardial injection of autologous CD34-positive cells (stem cells)Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle. | Biological | High dose of autologous CD34-positive cells (stem cells), Low dose of autologous CD34-positive cells (stem cells) |
Primary outcome
Safety of intramyocardial administration of CD34-positive cells
Time frame: 6 months
1 secondary outcome
Effects of intramyocardial injections of autologous CD34-positive cells on clinical outcomes.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Study terminated due to lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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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.
Douglas W. Losordo, M.D. principal investigator
Northwestern University
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 Intramyocardial injection of autologous CD34-positive cells (stem cells) in people with Myocardial Ischemia and Congestive Heart Failure, run by Losordo, Douglas, M.D. 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 7 inclusion and 7 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 31 Mar 2015. 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. 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: Study terminated due to lack of funding.). 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?
Safety of intramyocardial administration of CD34-positive cells (time frame: 6 months). 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 31 Mar 2015.