Safety Study of AMI MultiStem® to Treat Heart Attacks

NCT00677222 | Completed Phase 1 DMC

• 1 other identifier: AMI-07-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial Infarction, Heart Attack

Outcome Measures

Primary Outcomes (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

  30 days

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

1

EXPERIMENTAL

Treatment arm

Biological: AMI MultiStem®

2

NO INTERVENTION

Registry Arm -standard of care

Interventions

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.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Healios K.K.: lead
• PPD Development, LP: collaborator
• Angiotech Pharmaceuticals: collaborator

Study Sites (7)

Cardiology PC

Birmingham, Alabama, 35211, United States

Location

The Care Group

Indianapolis, Indiana, 46260, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Metro Health

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Hamot Medical Center

Erie, Pennsylvania, 16507, United States

Location

Related Publications (1)

• 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.

  PMID: 22052917 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Marc Penn, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Warren Sherman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 14, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: February 1, 2012
• Last Updated: May 11, 2012

Record last verified: 2012-05

Locations

US (7)