Safety and Efficacy on Cell-based Therapy in Patients With Recent Large Acute Myocardial Infarction

NCT00691834 | Withdrawn Phase 2 DMC

• 1 other identifier: Pro00003467
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.

Conditions

Acute Myocardial Infarction; Heart Failure

Keywords

Magnetic resonance Imaging

Outcome Measures

Primary Outcomes (2)

• Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients

  baseline and 90 days

• Occurence of arrhythmia, heart failure and death

  1 year

Secondary Outcomes (1)

• Improvement in regional left ventricular function

  90 days

Study Arms (2)

1

EXPERIMENTAL

Intracoronary delivery of unfractionated bone marrow mononuclear cells

Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells

2

PLACEBO COMPARATOR

Intracoronary delivery of placebo

Biological: Placebo

Interventions

Intracoronary delivery of unfractionated bone marrow mononuclear cells BIOLOGICAL

Maximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium)

1

Placebo BIOLOGICAL

Plasma and culture medium (10 ml)

2

Eligibility Criteria

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

You may qualify if:

• Be at least 18 years of age and no more than 80 years of age.
• Acute ST-segment elevation MI
• Symptoms suggestive of acute MI
• ≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block
• Time from symptom onset to enrollment \< 120 hours
• Left ventricular dysfunction by contrast ventriculography or echocardiography
• EF above 25 % and lower than 40%
• Focal wall motion akinesis or dyskinesis
• Clearly identifiable infarct artery
• Patent infarct artery (TIMI flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement

You may not qualify if:

• Planned treatment with bypass surgery or prior CABG
• Multi-vessel PCI
• Prior myocardial infarction by history or presence of pathologic Q-waves
• Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes
• Successful reperfusion \< 3 hrs from symptom onset
• Prior MI or significant chronic heart failure
• Pacemaker/defibrillator
• Contraindication to MRI (metallic foreign body, claustrophobia, inability to lie flat)
• Significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance\<25 and/or serum Cr \>2.5 mg/dl)
• Baseline hematocrit \< 30
• Pregnancy, or lactation/parturition within the past 30 days
• Active or planned treatment with chemotherapy
• Anticipated difficulty with 90-day follow-up
• Evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are HIV, hepatitis B or C positive
• Any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial

Sponsors & Collaborators

• Duke University: lead
• Duke Clinical Research Institute: collaborator

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Christopher B Granger, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Marc E Jolicoeur, MD MSc

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 6, 2008
• Study Start: August 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 13, 2013

Record last verified: 2012-11