Coronary DiseasePhase 1/2NCT00395811
Stem Cell Therapy to Improve Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
A Phase 1/2 study testing Bone Marrow Stem Cell Therapy combined CABG in people with Coronary Disease and Myocardial Infarction, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Disease, Myocardial Infarction
- What is being tested?
- Bone Marrow Stem Cell Therapy combined CABG
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Jun 2009
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary disease undergoing CABG.
- At least 3 months since last episode of myocardial infarction
- Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography.
- Reversible myocardial ischemia as revealed by SPECT. ejection fraction >=40% <=50%. Age >=18 years and <=70 Patients who can give informed consent themselves in writing.
- Negative pregnancy test (in women with childbearing potential).
Who cannot join
- Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
- Sustained ventricular tachycardia in a 24-hour ECG.
- Chronic atrial fibrillation.
- Less than 3 months since last episode of cerebral infarction.
- Patients with a malignant tumor*.
- Patients with chronic rheumatoid arthritis.
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- Patients with a history of severe allergic reactions.
- Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
- Patients currently suffering from or having a history of interstitial pneumonitis.
- Leukocytes less than 4,000/µL or exceeding 10,000/µL.
- Platelets less than 100,000/µL.
- Hemoglobin less than 10 g/dL.
- AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
- Patients for whom it is impossible to perform both cardiac MRI
- Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
- Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with myocardial infarction.
50 patients with stable left ventricle function will - with six months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories and Coronary Artery Bypass Graft (CABG).
Read the detailed description
This research study is being performed to find out more information about the safety and efficacy of autologous bone marrow stem cells transplantation. In patients with myocardial infarction, the heart muscle does not pump well. Over a period of years, this continues to get worse until the patient dies of heart failure. The researchers are trying to find out if the transplantation of these stem cell can make a change in the functioning of these areas of the heart muscle.
Patients between 18 and 70 years of age who received autologous bone marrow stem cell transplant at the Fuwai cardiovascular hospital may be eligible for this study. Candidates must have had their first transplant at least 3 years before entering the current study.
These patients receive autologous bone marrow cells transplantation intracoronary undergoing Coronary Artery Bypass Graft. The objective evaluations will be performed at baseline and during 6 months follow-up.
Heart function tests may include the following:
- Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
- Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
- Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
- MRI evaluates function of the heart chambers the beating motion of the muscle.
- Conditions
- Coronary Disease, Myocardial Infarction
- Being tested
- Bone Marrow Stem Cell Therapy combined CABG
- Keywords
- Myocardial Infarction, stem cell therapy, Coronary Artery Bypass Grafting
- Medical subject headings
- Coronary Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Stem Cell Therapy combined CABGProcedure or surgery
Bone Marrow Stem Cell inject into myocardium
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in left ventricular ejection fraction from baseline to 6 months' follow-up
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startJan 2007
- Primary completionApr 2009 (estimated)
- Study completionJun 2009 (estimated)
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 Coronary DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Investigators
- Hu shengshou, Study director, National center for cardiovascular disease ,china
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395811
- Sponsor's protocol ID
- NCCD200601
- Status last verified
- Oct 2008
- First submitted
- 1 Nov 2006
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hu S, Liu S, Zheng Z, Yuan X, Li L, Lu M, Shen R, Duan F, Zhang X, Li J, Liu X, Song Y, Wang W, Zhao S, He Z, Zhang H, Yang K, Feng W, Wang X. Isolated coronary artery bypass graft combined with bone marrow mononuclear cells delivered through a graft vessel for patients with previous myocardial infarction and chronic heart failure: a single-center, randomized, double-blind, placebo-controlled clinical trial. J Am Coll Cardiol. 2011 Jun 14;57(24):2409-15. doi: 10.1016/j.jacc.2011.01.037.
PubMed 21658561
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cell Therapy to Improve Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
- ClinicalTrials.gov ID
- NCT00395811
- Acronym / sponsor ID
- NCCD200601
- Conditions
- Coronary Disease, Myocardial Infarction
- Keywords
- Myocardial Infarction, stem cell therapy, Coronary Artery Bypass Grafting
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Jan 2007
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 3 Nov 2006 (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 whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with myocardial infarction.
50 patients with stable left ventricle function will - with six months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories and Coronary Artery Bypass Graft (CABG).
Detailed description
This research study is being performed to find out more information about the safety and efficacy of autologous bone marrow stem cells transplantation. In patients with myocardial infarction, the heart muscle does not pump well. Over a period of years, this continues to get worse until the patient dies of heart failure. The researchers are trying to find out if the transplantation of these stem cell can make a change in the functioning of these areas of the heart muscle.
Patients between 18 and 70 years of age who received autologous bone marrow stem cell transplant at the Fuwai cardiovascular hospital may be eligible for this study. Candidates must have had their first transplant at least 3 years before entering the current study.
These patients receive autologous bone marrow cells transplantation intracoronary undergoing Coronary Artery Bypass Graft. The objective evaluations will be performed at baseline and during 6 months follow-up.
Heart function tests may include the following:
- Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
- Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
- Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
- MRI evaluates function of the heart chambers the beating motion of the muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with coronary disease undergoing CABG.
- At least 3 months since last episode of myocardial infarction
- Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography.
- Reversible myocardial ischemia as revealed by SPECT. ejection fraction >=40% <=50%. Age >=18 years and <=70 Patients who can give informed consent themselves in writing.
- Negative pregnancy test (in women with childbearing potential).
Key exclusion criteria (16 listed)
- Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
- Sustained ventricular tachycardia in a 24-hour ECG.
- Chronic atrial fibrillation.
- Less than 3 months since last episode of cerebral infarction.
- Patients with a malignant tumor*.
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 |
|---|---|---|
| Bone Marrow Stem Cell Therapy combined CABGBone Marrow Stem Cell inject into myocardium | Procedure or surgery | – |
Primary outcome
Changes in left ventricular ejection fraction from baseline to 6 months' follow-up
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2008.
- Derived from this study: PubMed 21658561Hu S, Liu S, Zheng Z, Yuan X, Li L, Lu M, Shen R, Duan F, Zhang X, Li J, Liu X, Song Y, Wang W, Zhao S, He Z, Zhang H, Yang K, Feng W, Wang X. Isolated coronary artery bypass graft combined with bone marrow mononuclear cells delivered through a graft vessel for patients with previous myocardial infarction and chronic heart failure: a single-center, randomized, double-blind, placebo-controlled clinical trial. J Am Coll Cardiol. 2011 Jun 14;57(24):2409-15. doi: 10.1016/j.jacc.2011.01.037.
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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.
Hu shengshou study director
National center for cardiovascular disease ,china
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bone Marrow Stem Cell Therapy combined CABG in people with Coronary Disease and Myocardial Infarction, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 16 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: status not confirmed, as of the sponsor's last update on 29 Oct 2008. 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 China. 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 combined 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.
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?
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?
Changes in left ventricular ejection fraction from baseline to 6 months' follow-up (time frame: 3 year). 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 NCT00395811, 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 29 Oct 2008.