NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction

ST Segment Elevation Myocardial Infarction Clinical Trial

— PreSERVE-AMI  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495364
• Other study ID #: 002
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2011
• Last updated: April 26, 2016
• Start date: December 2011
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Caladrius Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Efficacy endpoint is at 6 months. Clinical endpoints and safety will be measured through 36 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: April 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or older.

2. 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.

3. 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.

4. Wall motion abnormality associated with the target lesion

5. NYHA heart failure class I, II or III.

6. Study entry LVEF <48% determined by CMR no sooner than 96 hours from stent placement.

7. Able to provide informed written consent and willing to participate in all required study follow-up assessments.

8. Subjects must have an INR = 2.0 within 2 days of the bone marrow collection.

9. 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.

10. Expected survival of at least one year.

11. Females of child bearing potential agree to use birth control (barrier method accepted) for one month post bone marrow harvest.

EXCLUSION CRITERIA

1. 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.

2. 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.

3. Subjects unable to receive antiplatelet agents (e.g. aspirin, clopidogrel, ticlopidine, prasugrel, etc).

4. Subjects receiving warfarin who have an INR >2 or with major bleeding requiring active transfusion support.

5. 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.)

6. Subjects with severe cardiac valvular disease expected to undergo surgery within 1 year.

7. Subjects with known severe immunodeficiency states (AIDS).

8. Cirrhosis requiring active medical management.

9. Malignancy requiring active treatment (except basal cell skin cancer).

10. Subjects with documented active alcohol and /or other substance abuse.

11. Females of child bearing potential unless a pregnancy test is negative within 7 days of the mini-bone marrow harvest.

12. Re-occlusion of the IRA prior to the infusion procedure.

13. 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).

14. Participation in an ongoing investigational trial.

15. Active or suspected bacterial infection requiring systemic intravenous antibiotics.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Segment Elevation Myocardial Infarction

Intervention

Biological:
• NBS10
dosage = 10 or more million CD34+ cells via intracoronary infusion

Other:
• placebo
matching placebo

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Medical Center	Atlanta	Georgia
United States	St. Joseph's Research Institute	Atlanta	Georgia
United States	Austin Heart	Austin	Texas
United States	University of Maryland Med Center, Baltimore	Baltimore	Maryland
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Maimonides Medical Center-Brooklyn	Brooklyn	New York
United States	Buffalo General Medical Center/Roswell Park Cancer Institute	Buffalo	New York
United States	Presbyterian CVI Research	Charlotte	North Carolina
United States	UVA Health System Cardiology Research	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Detroit Medical Center	Detroit	Michigan
United States	Henry Ford Health Systems	Detroit	Michigan
United States	Advocate Health and Hospital Corp.	Downer's Grove	Illinois
United States	Advocate Health and Hospital Corp.	Elmhurst	Illinois
United States	Detroit Clinical Research Center PC	Farmington Hills	Michigan
United States	Metrowest Medical Center	Framingham	Massachusetts
United States	Northeast Georgia Heart Center	Gainesville	Georgia
United States	University of Florida-Gainesville	Gainesville	Florida
United States	University of Texas Medical Branch - Galveston	Galveston	Texas
United States	CaroMont Heart	Gastonia	North Carolina
United States	Mercy Gilbert Medical Group	Gilbert	Arizona
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Texas Heart Institute	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Heart Center Research, LLC (Huntsville Hospital)	Huntsville	Alabama
United States	St. Vincent's Medical Group/St. Vincent's Heart Center of Indiana	Indianapolis	Indiana
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Scripps-La Jolla, CA	La Jolla	California
United States	University of Kentucky, Gill Heart Institute	Lexington	Kentucky
United States	Keck School of Medicine - University of Southern California	Los Angeles	California
United States	Louisville Cardiology Medical Group	Louisville	Kentucky
United States	Centra Lynchburg General Hospital	Lynchburg	Virginia
United States	Stern Cardiovascular Foundation/Baptist Hospital	Memphis	Tennessee
United States	Aurora Health Care Metro, Inc/St. Lukes Medical Center	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	University of Medicine and Dentistry of New Jersey	Newark	New Jersey
United States	University of Oklahoma Health and Sciences Center	Oaklahoma City	Oklahoma
United States	Orlando Health Medical Center	Orlando	Florida
United States	St.Johns Regional Hospital and Medical Center	Oxnard	California
United States	Drexel University/Hahnemann University Medical Center	Philadelphia	Pennsylvania
United States	Mayo Clinic - Arizona	Phoenix	Arizona
United States	University of PIttsburg Medical Center	Pittsburg	Pennsylvania
United States	Miriam Hospital	Providence	Rhode Island
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Methodist Health Systems of San Antonio	San Antonio	Texas
United States	Standford University School of Medicine	Stanford	California
United States	Stony Brook University Hospital and Medical Center	Stony Brook	New York
United States	Pepin Heart Institute - Florida Hospital -Tampa	Tampa	Florida
United States	Cardiology Asociates Research LLC	Tupelo	Mississippi
United States	Westchester Medical Center	Valhalla	New York
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Caladrius Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes