Acute Myocardial InfarctionPhase 2ReNeWNCT00691834
Safety and Efficacy on Cell-based Therapy in Patients With Recent Large Acute Myocardial Infarction
A Phase 2 study testing Intracoronary delivery of unfractionated bone marrow mononuclear cells in people with Acute Myocardial Infarction and Heart Failure, run by Duke University.
Trial summary
The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction, Heart Failure
- What is being tested?
- Intracoronary delivery of unfractionated bone marrow mononuclear cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Aug 2009
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age and no more than 80 years of age.
- Acute ST-segment elevation MI
- Symptoms suggestive of acute MI
- ≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block
- Time from symptom onset to enrollment < 120 hours
- Left ventricular dysfunction by contrast ventriculography or echocardiography
Show all 10Show fewer
- EF above 25 % and lower than 40%
- Focal wall motion akinesis or dyskinesis
- Clearly identifiable infarct artery
- Patent infarct artery (TIMI flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement
Who cannot join
- Planned treatment with bypass surgery or prior CABG
- Multi-vessel PCI
- Prior myocardial infarction by history or presence of pathologic Q-waves
- Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes
- Successful reperfusion < 3 hrs from symptom onset
- Prior MI or significant chronic heart failure
Show all 17Show fewer
- Pacemaker/defibrillator
- Contraindication to MRI (metallic foreign body, claustrophobia, inability to lie flat)
- Significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance<25 and/or serum Cr >2.5 mg/dl)
- Baseline hematocrit < 30
- Pregnancy, or lactation/parturition within the past 30 days
- Active or planned treatment with chemotherapy
- Anticipated difficulty with 90-day follow-up
- Evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are HIV, hepatitis B or C positive
- Any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial
- Previous enrollment in this trial
- Participation in an investigational drug or device study within the past 30 days
About this study
Official title: ReNEW: A Phase 2, Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Autologous Bone Marrow Mononuclear Cell Transfer for Myocardial Salvage in Acute Myocardial Infarction
The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Being tested
- Intracoronary delivery of unfractionated bone marrow mononuclear cells, Placebo
- Keywords
- Magnetic resonance Imaging
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary delivery of unfractionated bone marrow mononuclear cellsBiological
Maximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium)
PlaceboBiological
Plasma and culture medium (10 ml)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intracoronary delivery of unfractionated bone marrow mononuclear cells Receives: Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells |
| 2 | Placebo comparator | Intracoronary delivery of placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients
Measured: baseline and 90 days
Occurence of arrhythmia, heart failure and death
Measured: 1 year
Secondary outcomes (1)
Improvement in regional left ventricular function
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startAug 2009
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Study never received IRB approval. Study was never pursued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Christopher B Granger, MD, Principal investigator, Duke Clinical Research InstituteMarc E Jolicoeur, MD MSc, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691834
- Sponsor's protocol ID
- Pro00003467
- Acronym
- ReNeW
- Status last verified
- Nov 2012
- First submitted
- 3 Jun 2008
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReNEW: A Phase 2, Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Autologous Bone Marrow Mononuclear Cell Transfer for Myocardial Salvage in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00691834
- Acronym / sponsor ID
- ReNeW / Pro00003467
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Keywords
- Magnetic resonance Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never received IRB approval. Study was never pursued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute
- Study start
- Aug 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 6 Jun 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 test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cellsIntracoronary delivery of unfractionated bone marrow mononuclear cells |
| 2 | Placebo comparator | Biological: PlaceboIntracoronary delivery of placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be at least 18 years of age and no more than 80 years of age.
- Acute ST-segment elevation MI
- Symptoms suggestive of acute MI
- ≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block
- Time from symptom onset to enrollment < 120 hours
Key exclusion criteria (17 listed)
- Planned treatment with bypass surgery or prior CABG
- Multi-vessel PCI
- Prior myocardial infarction by history or presence of pathologic Q-waves
- Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes
- Successful reperfusion < 3 hrs from symptom onset
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 |
|---|---|---|
| Intracoronary delivery of unfractionated bone marrow mononuclear cellsMaximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium) | Biological | 1 |
| PlaceboPlasma and culture medium (10 ml) | Biological | 2 |
Primary outcome
Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients
Time frame: baseline and 90 days
Occurence of arrhythmia, heart failure and death
Time frame: 1 year
1 secondary outcome
Improvement in regional left ventricular function
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
Christopher B Granger, MD principal investigator
Duke Clinical Research Institute
Marc E Jolicoeur, MD MSc principal investigator
Duke Clinical Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intracoronary delivery of unfractionated bone marrow mononuclear cells in people with Acute Myocardial Infarction and Heart Failure, run by Duke University.
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 10 inclusion and 17 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: withdrawn, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients (time frame: baseline and 90 days). 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 13 Aug 2013.