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

This study has been withdrawn prior to enrollment.
(Study never received IRB approval. Study was never pursued.)
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00691834
First received: June 3, 2008
Last updated: August 12, 2013
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Heart Failure
Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ReNEW: A Phase 2, Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Autologous Bone Marrow Mononuclear Cell Transfer for Myocardial Salvage in Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients [ Time Frame: baseline and 90 days ] [ Designated as safety issue: No ]
  • Occurence of arrhythmia, heart failure and death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in regional left ventricular function [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intracoronary delivery of unfractionated bone marrow mononuclear cells
Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells
Maximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium)
Placebo Comparator: 2
Intracoronary delivery of placebo
Biological: Placebo
Plasma and culture medium (10 ml)

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Previous enrollment in this trial
  • Participation in an investigational drug or device study within the past 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691834

Sponsors and Collaborators
Duke University
Duke Clinical Research Institute
Investigators
Principal Investigator: Christopher B Granger, MD Duke Clinical Research Institute
Principal Investigator: Marc E Jolicoeur, MD MSc Duke Clinical Research Institute
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00691834     History of Changes
Other Study ID Numbers: Pro00003467
Study First Received: June 3, 2008
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Duke University:
Magnetic resonance Imaging

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

ClinicalTrials.gov processed this record on April 15, 2014