Safety Study of AMI MultiStem® to Treat Heart Attacks

This study has been completed.
Sponsor:
Collaborators:
PPD
Angiotech Pharmaceuticals
Information provided by (Responsible Party):
Athersys, Inc
ClinicalTrials.gov Identifier:
NCT00677222
First received: May 12, 2008
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to determine if escalating doses of AMI MultiStem® delivered by catheter can safely be given to patients that have had a recent heart attack treated with stent implantation.


Condition Intervention Phase
Acute Myocardial Infarction
Biological: AMI MultiStem®
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Multicenter, Dose-Escalation Trial Evaluating the Safety of Allogeneic AMI MultiStem® in Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Athersys, Inc:

Primary Outcome Measures:
  • Assessment of adverse events during the first 24 hours after administration of AMI MultiStem® and post acute adverse events up to 30 days following AMI [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of longer term safety and cardiac function over 12 months following AMI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: May 2008
Study Completion Date: February 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Treatment arm
Biological: AMI MultiStem®
AMI MultiStem® administered via catheter into peri-vascular space of the target vessel, 2-5 days post PCI. There will be 3 dose escalation cohorts, 6 patients per cohort.
No Intervention: 2
Registry Arm -standard of care

Detailed Description:

The mortality rates associated with acute myocardial infarction (AMI) have significantly decreased over the past 2 decades. Beginning first with thrombolytic therapy for AMI, and more recently with growing acceptance and availability of primary percutaneous coronary intervention (PCI) for ST-elevation AMI, the mortality rates of this devastating ischemic event have decreased from almost 15% in clinical trials in the late 1980's to <5% in recent primary percutaneous coronary intervention trials. Though AMI-related mortality has been reduced, AMI survival is often accompanied by significant loss of function that may lead to subsequent treatments, congestive heart failure (CHF) and reduction in quality of life. A cell therapy that could reduce the damage associated with AMI and positively affect heart function would provide substantial benefits to the AMI patient.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of either sex 18-85 years of age
  • Women of childbearing potential or less than 2 years postmenopausal agree to use of adequate contraception during the study
  • Patients with the first time diagnosis of ST elevation myocardial infarction
  • Acute myocardial infarction (ST elevation in at least two leads >0.2 mV in V1, V2 or V3 or >0.1 mV in other leads), treated by one of the following: either
  • Acute PCI with stent implantation
  • With thrombolysis within 12 hr of symptom onset followed by PCI with stent implantation within 24 hr after Thrombolysis
  • Maximal creatine kinase elevation >400 U/l with significant membrane-bound fraction (>6%)or troponin >2X ULN
  • Decreasing levels of CK/CK-MB or troponin following reperfusion
  • Successful acute PCI/stent implantation (residual stenosis visually <30% and TIMI flow >2). Absence of severe disorder of the microcirculation (e.g. pulsatile flow pattern, systolic flow reversal) at the time of administration of the trial therapy
  • Significant regional wall motion abnormality in left ventricular angiogram or transthoracic echocardiogram ≤48 hours post PCI
  • LVEF between 30 and 45% by LV gram after the primary PCI or transthoracic echocardiogram ≤48 hours post PCI
  • Willing and able to comply with the scheduled visits, treatment, laboratory tests and other study related procedures.
  • Signed informed consent

Exclusion Criteria:

  • Prior cardiovascular history
  • Mechanical complications of the index acute myocardial infarction including but not limited to rupture of the mitral valve with resultant development of mitral regurgitation, rupture of the left ventricular free wall and rupture of the interventricular septum
  • Pregnant or lactating
  • Known allergy to contrast agents
  • Known allergy or religious objections to bovine or porcine products
  • History of malignancy of any type except non-melanoma skin cancer
  • Presence of major hematological conditions or laboratory abnormalities (low hemoglobin (<10 gm/dl), - WBC (<3,000 cells/mm2) or platelet count (<100,000 cells/mm3))
  • Prothrombin time (PT) > 1x ULN
  • Partial thromboplastin time (PTT) > 1x ULN
  • Presence of chronic systemic inflammatory disorders that requires ongoing therapy
  • Previous autologous, allogeneic bone marrow or peripheral stem cell transplant
  • Prior solid organ transplantation
  • Immune system compromise including but not limited to history of human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV) infection.
  • Prior participation in any other study involving investigational pharmacological agents(s), devices or marketed products within 30 days prior to planned AMI MultiStem® administration
  • Life expectancy of six months or less
  • Current alcohol or substance abuse
  • Ongoing systemic infection
  • Renal function: Serum creatinine >2 mg/dL or creatinine clearance ≤50 mL/min
  • Hepatic function: Screening ALT and AST ≥3x upper limit of normal for the laboratory or total bilirubin ≥2.0 mg/dL (exception: acceptable if patient is identified with pre existing condition e.g. Gilbert's disease that will contribute to baseline elevations of bilirubin)
  • Other serious medical or psychiatric illness that, in the investigator's opinion, would not permit the patient to be managed according to the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677222

Locations
United States, Alabama
Cardiology PC
Birmingham, Alabama, United States, 35211
United States, Indiana
The Care Group
Indianapolis, Indiana, United States, 46260
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Metro Health
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Hamot Medical Center
Erie, Pennsylvania, United States, 16507
Sponsors and Collaborators
Athersys, Inc
PPD
Angiotech Pharmaceuticals
Investigators
Principal Investigator: Marc Penn, MD The Cleveland Clinic
Principal Investigator: Warren Sherman, MD Columbia University
  More Information

No publications provided by Athersys, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Athersys, Inc
ClinicalTrials.gov Identifier: NCT00677222     History of Changes
Other Study ID Numbers: AMI-07-001
Study First Received: May 12, 2008
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Athersys, Inc:
Acute Myocardial Infarction, Heart Attack

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014