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Acute Myocardial InfarctionPhase 1NCT00677222

Safety Study of AMI MultiStem® to Treat Heart Attacks

A Phase 1 study testing AMI MultiStem® in people with Acute Myocardial Infarction, run by Healios K.K. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
AMI MultiStem®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
7 sitesUnited States
Study dates
May 2008to Feb 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Cardiology PC

    Birmingham, Alabama, 35211

  • Metro Health

    Cleveland, Ohio, 44109

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Hamot Medical Center

    Erie, Pennsylvania, 16507

  • The Care Group

    Indianapolis, Indiana, 46260

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
AMI MultiStem®
Keywords
Acute Myocardial Infarction, Heart Attack
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMI MultiStem®Biological

    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.

Study groups in NCT00677222
Study groupRoleWhat they receive
1ExperimentalTreatment arm
Receives: Biological: AMI MultiStem®
2No interventionRegistry Arm -standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 days

Secondary outcomes (1)

  1. Evaluation of longer term safety and cardiac function over 12 months following AMI

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionMar 2010
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00677222
Sponsor's protocol ID
AMI-07-001
Status last verified
May 2012
First submitted
12 May 2008
Last updated
11 May 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Penn MS, Ellis S, Gandhi S, Greenbaum A, Hodes Z, Mendelsohn FO, Strasser D, Ting AE, Sherman W. Adventitial delivery of an allogeneic bone marrow-derived adherent stem cell in acute myocardial infarction: phase I clinical study. Circ Res. 2012 Jan 20;110(2):304-11. doi: 10.1161/CIRCRESAHA.111.253427. Epub 2011 Nov 3.

    PubMed 22052917

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMI MultiStem® in people with Acute Myocardial Infarction, run by Healios K.K. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00677222, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2012.

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