Safety and Efficacy on Cell-based Therapy in Patients Wit... | NCT00691834

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

NCT00691834

Sponsor

Duke University

Status

Withdrawn

Last Update Posted

Aug 13, 2013Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Acute Myocardial Infarction
Heart Failure

Interventions

Intracoronary delivery of unfractionated bone marrow mononuclear cells
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never received IRB approval. Study was never pursued.

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jun 3, 2008

First Submission Date that Met QC Criteria

Jun 3, 2008

First Posted Date

Jun 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2013

Last Update Posted Date

Aug 13, 2013Estimated

Name	Class
Duke Clinical Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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)

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Improvement in regional left ventricular function		90 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Christopher B Granger, MD	Duke Clinical Research Institute	Principal Investigator
Marc E Jolicoeur, MD MSc	Duke Clinical Research Institute	Principal Investigator

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases