Old Myocardial InfarctionPhase 1/2NCT01267331
Cell Therapy in Patients With Chronic Ischemic Heart Disease Undergoing Cardiac Surgery
A Phase 1/2 study testing bone marrow mononuclear cells injection in people with Old Myocardial Infarction and Chronic Myocardial Ischemia, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This prospective, randomized, placebo-controlled study was designed to assess the safety, feasibility and efficacy of intramyocardial injection of autologous bone marrow mononuclear cells in patients with severe, chronic ischemic disease scheduled to coronary artery bypass surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Old Myocardial Infarction, Chronic Myocardial Ischemia, Left Ventricular Dysfunction
- What is being tested?
- bone marrow mononuclear cells injection
- 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
- 1 siteChina
- Study dates
- Dec 2010to Jun 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- Scheduled to undergo CABG.
- At least 3 months since last episode of myocardial infarction.
- Echocardiogram-assessed LVEF between 15 and 40% (Simpson's rule).
- Abnormal wall motion of at least one segment due to prior myocardial infarction shown by echocardiography or left ventriculography.
- Abnormal myocardial perfusion in infarcted area by SPECT.
- Willingness to participate and ability to provide written informed consent.
Who cannot join
- Contraindications to magnetic resonance imaging.
- Need for urgent or emergent revascularization.
- Severe valvular heart disease.
- Confirmed myocardial infarction within 14 days, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes.
- Prior cardiac surgery.
- Stroke within 3 months prior to CABG.
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- Immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.)
- Severe chronic renal insufficiency (serum creatinine ≥ 200 mmol/dl or need for dialysis), liver disease, (diagnosis of cirrhosis, chronic hepatitis, or elevation of serum transaminases ≥3 times the upper limit of normal), cerebrovascular disease requiring concomitant carotid endarterectomy, peripheral arterial disease (claudication as the primary factor limiting activity), active non-dermatological malignancy requiring on-going treatment, or any other condition that would place the patient at increased risk for complications in the judgment of the attending cardiologist or cardiac surgeon
- Hemoglobin less than 10g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3
- Active infection, with a temperature greater than 37.5°C within 48 hrs prior to surgery and an unexplained white blood cell count in excess of 10,000/mm3
- Significant cognitive impairment.
- Any condition associated with a life expectancy of less than 6 months.
- Participation in other studies.
- Positive laboratory test results for HIV, HBC, and HCV.
- Pregnant woman.
- Inability or unwillingness to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Wang Rong, MD
Zhang Lin, MD
About this study
Official title: A Prospective,Randomized, Placebo-Controlled Study of Intramyocardial Injection of Autologous Bone-Marrow Mononuclear Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
This prospective, randomized, placebo-controlled study was designed to assess the safety, feasibility and efficacy of intramyocardial injection of autologous bone marrow mononuclear cells in patients with severe, chronic ischemic disease scheduled to coronary artery bypass surgery.
Read the detailed description
Severe ischemic heart disease remains a clinical challenge; many patients have undergone surgical myocardial revascularization procedures, but still remain symptomatic despite optimal medical therapy. Cell therapy with autologous bone marrow-derived cells (BMC) is a novel therapeutic strategy being tested for surgical treatment in patients with severe, chronic ischemic heart disease.
This research study is being performed to find out more information about the safety, feasibility, and efficacy of direct intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy (compared to placebo) in patients undergoing coronary artery bypass surgery (CABG). The heart function evaluations will be performed by electrocardiogram, echocardiogram, and cMRI at baseline and during 6 months follow-up.
The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class (angina/heart failure), global and cardiovascular mortality, and major adverse cardiac events after undergoing coronary artery bypass surgery.
- Being tested
- bone marrow mononuclear cells injection, placebo intramyocardial injection
- Keywords
- Old Myocardial Infarction, Stem Cell Therapy, Coronary Artery Bypass Grafting, Coronary Artery Disease
- Medical subject headings
- Ventricular Dysfunction, Left, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone marrow mononuclear cells injectionProcedure or surgery
Also called autologous bone marrow mononuclear cells
Participants will receive direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG.
placebo intramyocardial injectionProcedure or surgery
Also called palcebo
Participants will receive between 10 and 15 placebo injections that consist of saline and 5% human serum albumin during CABG.
| Study group | Role | What they receive |
|---|---|---|
| stem cells injection | Experimental | Direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG Receives: Procedure: bone marrow mononuclear cells injection |
| palcebo intramyocardial injection | Placebo comparator | Direct intramyocardial injection of placebo containing saline and 5% human serum albumin during CABG. Receives: Procedure: placebo intramyocardial injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac events
Freedom from Major Adverse Cardiac Event: cardiac death, myocardial infarction, repeat coronary bypass grafting or percutaneous intervention of bypassed artery
Measured: 6 months
Secondary outcomes (1)
left ventricular function
Globlal function,regional myocardial perfusion and function assessed by magnetic resonance iamge and echocardiogram
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 posted28 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gao Changqing, MD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267331
- Sponsor's protocol ID
- 2006AA02A104
- Status last verified
- Dec 2010
- First submitted
- 23 Dec 2010
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Randomized, Placebo-Controlled Study of Intramyocardial Injection of Autologous Bone-Marrow Mononuclear Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
- ClinicalTrials.gov ID
- NCT01267331
- Acronym / sponsor ID
- 2006AA02A104
- Keywords
- Old Myocardial Infarction, Stem Cell Therapy, Coronary Artery Bypass Grafting, Coronary Artery Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 28 Dec 2010 (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 prospective, randomized, placebo-controlled study was designed to assess the safety, feasibility and efficacy of intramyocardial injection of autologous bone marrow mononuclear cells in patients with severe, chronic ischemic disease scheduled to coronary artery bypass surgery.
Detailed description
Severe ischemic heart disease remains a clinical challenge; many patients have undergone surgical myocardial revascularization procedures, but still remain symptomatic despite optimal medical therapy. Cell therapy with autologous bone marrow-derived cells (BMC) is a novel therapeutic strategy being tested for surgical treatment in patients with severe, chronic ischemic heart disease.
This research study is being performed to find out more information about the safety, feasibility, and efficacy of direct intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy (compared to placebo) in patients undergoing coronary artery bypass surgery (CABG). The heart function evaluations will be performed by electrocardiogram, echocardiogram, and cMRI at baseline and during 6 months follow-up.
The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class (angina/heart failure), global and cardiovascular mortality, and major adverse cardiac events after undergoing coronary artery bypass surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stem cells injection | Experimental | Procedure: bone marrow mononuclear cells injectionDirect intramyocardial injection of autologous bone marrow mononuclear cells during CABG |
| palcebo intramyocardial injection | Placebo comparator | Procedure: placebo intramyocardial injectionDirect intramyocardial injection of placebo containing saline and 5% human serum albumin during CABG. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75 years.
- Scheduled to undergo CABG.
- At least 3 months since last episode of myocardial infarction.
- Echocardiogram-assessed LVEF between 15 and 40% (Simpson's rule).
- Abnormal wall motion of at least one segment due to prior myocardial infarction shown by echocardiography or left ventriculography.
Key exclusion criteria (16 listed)
- Contraindications to magnetic resonance imaging.
- Need for urgent or emergent revascularization.
- Severe valvular heart disease.
- Confirmed myocardial infarction within 14 days, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes.
- Prior cardiac surgery.
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 mononuclear cells injectionAlso: autologous bone marrow mononuclear cellsParticipants will receive direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG. | Procedure or surgery | stem cells injection |
| placebo intramyocardial injectionAlso: palceboParticipants will receive between 10 and 15 placebo injections that consist of saline and 5% human serum albumin during CABG. | Procedure or surgery | palcebo intramyocardial injection |
Primary outcome
major adverse cardiac events
Time frame: 6 months
Freedom from Major Adverse Cardiac Event: cardiac death, myocardial infarction, repeat coronary bypass grafting or percutaneous intervention of bypassed artery
1 secondary outcome
left ventricular function
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2011.
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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.
Gao Changqing, MD study chair
Chinese PLA General Hospital
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 mononuclear cells injection in people with Old Myocardial Infarction and Chronic Myocardial Ischemia, run by Chinese PLA General Hospital 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 7 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 12 Jan 2011. 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. 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 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?
Contact Changqing Gao, MD (+8601066938035, gaochq301@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiac events (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 12 Jan 2011.