NCT00463853

Brief Summary

The purpose of this study is to determine whether it is safe to receive an injection of your own bone marrow adult stem cells (autologous BM-MNC) to your heart wall during coronary artery bypass graft (CABG).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

June 11, 2014

Status Verified

June 1, 2014

Enrollment Period

1.9 years

First QC Date

April 17, 2007

Last Update Submit

June 10, 2014

Conditions

Coronary ArteriosclerosisCoronary Artery Bypass GraftMyocardial Revascularization

Keywords

Bone Marrow CellsCardiovascular SurgeryCoronary Artery Bypass GraftPhase I StudyStem Cells

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure will be safety as measured by the incidence of postoperative serious adverse events (SAE) and adverse events (AE).

    1 year

Secondary Outcomes (4)

  • Ejection fraction measured by CMRI

    at baseline, 3 & 6 months

  • Echo

    at baseline, intervention, 2 weeks, 1 month, 3 months, 6 months and 1 year

  • Myocardial perfusion measured by gadolinium CMRI

    at baseline, 3 & 6 months

  • Exercise tolerance testing

    at baseline, 1 month, 3 months, 6 months, and 1 year

Study Arms (1)

Arm 1

EXPERIMENTAL

direct intramyocardial injection of cells as adjunct to CABG

Procedure: Autologous stem cell therapyProcedure: CABGRadiation: CMRI

Interventions

Autologous stem cell therapyPROCEDURE
Arm 1
CABGPROCEDURE
Arm 1
CMRIRADIATION
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran
  • Age 18 or older
  • Ability to give informed consent
  • Have documented CAD and depressed LV function (EF \<40%) that is felt to be appropriately treated with surgical revascularization by the VA Salt Lake City Health Care System Cardiothoracic Surgery team and in accordance with the published 2004 ACC/AHA Guideline Update for Coronary Artery Bypass Graft Surgery; specifically, in accordance with the described indication for CABG in patients with Poor LV Function (see below).
  • Class I
  • CABG should be performed in patients with poor LV function who have significant left main coronary artery stenosis. (Level of Evidence: B)
  • CABG should be performed in patients with poor LV function who have left main equivalent:
  • significant (greater than or equal to 70%) stenosis of the proximal LAD and proximal left circumflex artery. (Level of Evidence: B)
  • CABG should be performed in patients with poor LV function who have proximal LAD stenosis with 2- or 3-vessel disease. (Level of Evidence: B)
  • Class IIa
  • CABG may be performed in patients with poor LV function with significant viable noncontracting, revascularizable myocardium and without any of the above anatomic patterns. (Level of Evidence: B)
  • NHYA/CCA Class I or higher
  • Abnormal cardiac wall segment on preoperative data
  • Acutely stable myocardium without evidence of cardiogenic shock or evolving myocardial infarction

You may not qualify if:

  • EF 40%
  • CAD not amenable to CABG
  • ACC/AHA Poor LV Function Class III - CABG should not be performed in patients with poor LV function without evidence of intermittent ischemia and without evidence of significant revascularizable viable myocardium. (Level of Evidence: B) Evidence of intermittent ischemia is defined clinically by Cardiovascular Disease Classification (see chart above). Objectively, this can be demonstrated by various modalities that can demonstrate ischemic myocardium. Such modalities include SCA, Echo, CMRI, and radionucleotide imaging.
  • Patients undergoing cardiac re-operation
  • Patients with operable valvular disease
  • Patients with preexisting malignant arrhythmia
  • Patients with preexisting systemic malignancy
  • Patients with a contraindication to MRI
  • Presence of ongoing local or systemic infection
  • Participation in another clinical trial
  • Emergency operation
  • Preoperative cardiogenic shock or evolving myocardial infarction
  • ASA Class V or contraindication to general anesthesia
  • Pregnancy
  • Prisoner
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Salt Lake City Health Care System, Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • G. Russell Reiss, MD

    VA Salt Lake City Health Care System, Salt Lake City

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 20, 2007

Study Start

August 1, 2007

Primary Completion

July 1, 2009

Study Completion

October 1, 2009

Last Updated

June 11, 2014

Record last verified: 2014-06

Locations

US(1)