Safety Study of AMI MultiStem® to Treat Heart Attacks

May 10, 2012 updated by: Athersys, Inc

A Phase I, Multicenter, Dose-Escalation Trial Evaluating the Safety of Allogeneic AMI MultiStem® in Patients With Acute Myocardial Infarction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Cardiology PC
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • The Care Group
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44109
        • Metro Health
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Hamot Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of longer term safety and cardiac function over 12 months following AMI
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Athersys, Inc

Collaborators

PPD
Angiotech Pharmaceuticals

Investigators

  • Principal Investigator: Warren Sherman, MD, Columbia University
  • Principal Investigator: Marc Penn, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 12, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 14, 2008

Study Record Updates

Last Update Posted (Estimate)

May 11, 2012

Last Update Submitted That Met QC Criteria

May 10, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMI-07-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myocardial Infarction

Clinical Trials on AMI MultiStem®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe