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

Heart Failure Clinical Trial

— ReNeW  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00691834
• Other study ID #: Pro00003467
• Status: Withdrawn
• Phase: Phase 2
• First received: June 3, 2008
• Last updated: August 12, 2013
• Start date: August 2009
• Est. completion date: August 2009

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

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
Plasma and culture medium (10 ml)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Duke Clinical Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients		baseline and 90 days	No
Primary	Occurence of arrhythmia, heart failure and death		1 year	Yes
Secondary	Improvement in regional left ventricular function		90 days	No