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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.
Efficacy endpoint is at 6 months. Clinical endpoints and safety will be measured through 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBS10 | Experimental | active treatment - CD34+ cells |
|
| placebo | Placebo Comparator | matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBS10 | Biological | dosage = 10 or more million CD34+ cells via intracoronary infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine safety and efficacy of intracoronary infusion of NBS10. | 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. | primary outcome measured at 6 months |
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Inclusion Criteria:
Age 18 years or older.
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
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| Name | Affiliation | Role |
|---|---|---|
| Tom Moss, MD | Lisata Therapeutics, Inc. | Study Director |
| Arshed Quyyumi, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Heart Center Research, LLC (Huntsville Hospital) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27821724 | Derived | Quyyumi AA, Vasquez A, Kereiakes DJ, Klapholz M, Schaer GL, Abdel-Latif A, Frohwein S, Henry TD, Schatz RA, Dib N, Toma C, Davidson CJ, Barsness GW, Shavelle DM, Cohen M, Poole J, Moss T, Hyde P, Kanakaraj AM, Druker V, Chung A, Junge C, Preti RA, Smith RL, Mazzo DJ, Pecora A, Losordo DW. PreSERVE-AMI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Intracoronary Administration of Autologous CD34+ Cells in Patients With Left Ventricular Dysfunction Post STEMI. Circ Res. 2017 Jan 20;120(2):324-331. doi: 10.1161/CIRCRESAHA.115.308165. Epub 2016 Nov 7. |
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| placebo | Other | matching placebo |
|
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Mercy Gilbert Medical Group | Gilbert | Arizona | 85297 | United States |
| Mayo Clinic - Arizona | Phoenix | Arizona | 85054 | United States |
| Scripps-La Jolla, CA | La Jolla | California | 92037 | United States |
| Keck School of Medicine - University of Southern California | Los Angeles | California | 90033 | United States |
| St.Johns Regional Hospital and Medical Center | Oxnard | California | 93030 | United States |
| Standford University School of Medicine | Stanford | California | 94305 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida-Gainesville | Gainesville | Florida | 32610 | United States |
| Orlando Health Medical Center | Orlando | Florida | 32806 | United States |
| Pepin Heart Institute - Florida Hospital -Tampa | Tampa | Florida | 33513 | United States |
| Emory University Medical Center | Atlanta | Georgia | 30322 | United States |
| St. Joseph's Research Institute | Atlanta | Georgia | 30342 | United States |
| Northeast Georgia Heart Center | Gainesville | Georgia | 30501 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Advocate Health and Hospital Corp. | Downer's Grove | Illinois | 60515 | United States |
| Advocate Health and Hospital Corp. | Elmhurst | Illinois | 60126 | United States |
| St. Vincent's Medical Group/St. Vincent's Heart Center of Indiana | Indianapolis | Indiana | 46260 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Kentucky, Gill Heart Institute | Lexington | Kentucky | 40536 | United States |
| Louisville Cardiology Medical Group | Louisville | Kentucky | 40207 | United States |
| University of Maryland Med Center, Baltimore | Baltimore | Maryland | 21201 | United States |
| Metrowest Medical Center | Framingham | Massachusetts | 01702 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Detroit Medical Center | Detroit | Michigan | 48201 | United States |
| Henry Ford Health Systems | Detroit | Michigan | 48202 | United States |
| Detroit Clinical Research Center PC | Farmington Hills | Michigan | 48334 | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Cardiology Asociates Research LLC | Tupelo | Mississippi | 38801 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| University of Medicine and Dentistry of New Jersey | Newark | New Jersey | 07103 | United States |
| Maimonides Medical Center-Brooklyn | Brooklyn | New York | 11219 | United States |
| Buffalo General Medical Center/Roswell Park Cancer Institute | Buffalo | New York | 14203 | United States |
| Stony Brook University Hospital and Medical Center | Stony Brook | New York | 11794-8167 | United States |
| Westchester Medical Center | Valhalla | New York | 10532 | United States |
| Presbyterian CVI Research | Charlotte | North Carolina | 28024 | United States |
| CaroMont Heart | Gastonia | North Carolina | 28054 | United States |
| The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| University of Oklahoma Health and Sciences Center | Oaklahoma City | Oklahoma | 73104 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Drexel University/Hahnemann University Medical Center | Philadelphia | Pennsylvania | 19102 | United States |
| University of PIttsburg Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Miriam Hospital | Providence | Rhode Island | 02904 | United States |
| Stern Cardiovascular Foundation/Baptist Hospital | Memphis | Tennessee | 38138 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| University of Texas Medical Branch - Galveston | Galveston | Texas | 77555 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Methodist Health Systems of San Antonio | San Antonio | Texas | 78229 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| UVA Health System Cardiology Research | Charlottesville | Virginia | 22908 | United States |
| Centra Lynchburg General Hospital | Lynchburg | Virginia | 25401 | United States |
| Aurora Health Care Metro, Inc/St. Lukes Medical Center | Milwaukee | Wisconsin | 53233 | United States |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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