NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction (PreSERVE-AMI)
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| ClinicalTrials.gov Identifier: NCT01495364 |
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Recruitment Status :
Completed
First Posted : December 20, 2011
Last Update Posted : April 28, 2016
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Sponsor:
Lisata Therapeutics, Inc.
Information provided by (Responsible Party):
Lisata Therapeutics, Inc.
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Brief Summary:
This study will assess the safety and efficacy of intracoronary artery administered autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial infarction (STEMI). This will be assessed by evaluating and comparing the autologous stem cell treatment group to the control group in terms of the occurrence of AE's, SAE's and Major Adverse Cardiac Events (MACE), by the change in myocardial perfusion (RTSS) measured quantitatively by gated single photon emission computed tomography myocardial perfusion imaging (gated SPECT MPI), and other secondary endpoints such as LVEF measured by cardiac MRI in addition to other endpoints.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| ST Segment Elevation Myocardial Infarction | Biological: NBS10 Other: placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 195 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective Randomized Double Blind Placebo Controlled Phase II Trial of Intra-coronary Infusion of AMR-001, a Bone Marrow Derived Autologous CD34+ Selected Cell Product, in Patients With Acute Myocardial Infarction. |
| Study Start Date : | December 2011 |
| Actual Primary Completion Date : | June 2014 |
| Actual Study Completion Date : | April 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Attack
| Arm | Intervention/treatment |
|---|---|
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Experimental: NBS10
active treatment - CD34+ cells
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Biological: NBS10
dosage = 10 or more million CD34+ cells via intracoronary infusion
Other Name: AMR-001 |
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Placebo Comparator: placebo
matching placebo
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Other: placebo
matching placebo |
Primary Outcome Measures :
- To determine safety and efficacy of intracoronary infusion of NBS10. [ Time Frame: primary outcome measured at 6 months ]The primary endpoint includes the occurrence of AE's, SAE's and Major Adverse Cardiac Events (MACE) and the assessment of myocardial perfusion measured by quantitative gated SPECT MPI specifically looking at resting total severity score.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 years or older.
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Acute ST elevation myocardial infarction meeting ACC/AHA criteria, with symptoms of chest pain within 3 days of admission. Criteria include (ST elevation > 1mm in limb leads or 2 mm in two or more precordial leads, and increased levels of troponin, CPK MB or both).
Chest pain syndrome can extend to more than 3 days prior to admission if its course is consistent with transient/intermittent ischemia rather than symptoms that are continuous suggesting ongoing infarction extending beyond 3 days.
- Successful stent placement and reperfusion within 3 days of chest pain onset and with TIMI Flow score of 2 or 3 and infarct related artery (IRA) with <20% stenosis after revascularization.
- Wall motion abnormality associated with the target lesion
- NYHA heart failure class I, II or III.
- Study entry LVEF <48% determined by CMR no sooner than 96 hours from stent placement.
- Able to provide informed written consent and willing to participate in all required study follow-up assessments.
- Subjects must have an INR ≤ 2.0 within 2 days of the bone marrow collection.
- Subjects must have a Hgb ≥ 10 grams/dL, WBC ≥ 3500 cells/mm3, a platelet count ≥ 100,000 cells/mm3, serum creatinine ≤ 2.5, and total bilirubin ≤ 2.0 within 7 days of the bone marrow collection or by end of screening phase.
- Expected survival of at least one year.
- Females of child bearing potential agree to use birth control (barrier method accepted) for one month post bone marrow harvest.
EXCLUSION CRITERIA
- Continuous/ongoing chest pain - unremitting and unresponsive to nitroglycerin or rest - persisting 4 or more days before stent placement. If the chest pain syndrome is transient and/or intermittent - even if it began more than 3 days prior to admission - the patient is not excluded.
- Subjects in cardiogenic shock (systolic pressure < 80mm/Hg, on vasopressors, or intra-aortic counterpulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible.
- Subjects unable to receive antiplatelet agents (e.g. aspirin, clopidogrel, ticlopidine, prasugrel, etc).
- Subjects receiving warfarin who have an INR >2 or with major bleeding requiring active transfusion support.
- Subjects who require continuous anticoagulation during the time when the bone marrow harvest is scheduled, as heparin must be discontinued for 4 hours prior to and 24 hours after bone marrow harvest procedure. (See Appendix VII.)
- Subjects with severe cardiac valvular disease expected to undergo surgery within 1 year.
- Subjects with known severe immunodeficiency states (AIDS).
- Cirrhosis requiring active medical management.
- Malignancy requiring active treatment (except basal cell skin cancer).
- Subjects with documented active alcohol and /or other substance abuse.
- Females of child bearing potential unless a pregnancy test is negative within 7 days of the mini-bone marrow harvest.
- Re-occlusion of the IRA prior to the infusion procedure.
- Planned revascularization intervention during the next 6 months (A second PCI can be performed if done prior to qualifying CMR at least 96 hours post primary PCI).
- Participation in an ongoing investigational trial.
- Active or suspected bacterial infection requiring systemic intravenous antibiotics.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495364
Locations
Show 58 study locations
Sponsors and Collaborators
Lisata Therapeutics, Inc.
Investigators
| Study Director: | Tom Moss, MD | Lisata Therapeutics, Inc. | |
| Principal Investigator: | Arshed Quyyumi, MD | Emory University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lisata Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01495364 |
| Other Study ID Numbers: |
002 |
| First Posted: | December 20, 2011 Key Record Dates |
| Last Update Posted: | April 28, 2016 |
| Last Verified: | April 2016 |
Keywords provided by Lisata Therapeutics, Inc.:
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STEMI |
Additional relevant MeSH terms:
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Myocardial Infarction ST Elevation Myocardial Infarction Infarction Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |