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Stem Cell Therapy as Adjunct to Revascularization (STAR)

Primary Purpose

Coronary Arteriosclerosis, Coronary Artery Bypass Graft, Myocardial Revascularization

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous stem cell therapy
CABG
CMRI
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis focused on measuring Bone Marrow Cells, Cardiovascular Surgery, Coronary Artery Bypass Graft, Phase I Study, Stem Cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

  1. CABG should be performed in patients with poor LV function who have significant left main coronary artery stenosis. (Level of Evidence: B)

  2. 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)

  3. 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

Exclusion Criteria:

  • 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
  • Active history of alcohol or substance abuse
  • Active psychiatric history leading to potential for poor study participation and follow-up

Sites / Locations

  • VA Salt Lake City Health Care System, Salt Lake City

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

direct intramyocardial injection of cells as adjunct to CABG

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ejection fraction measured by CMRI
Echo
Myocardial perfusion measured by gadolinium CMRI
Exercise tolerance testing

Full Information

First Posted
April 17, 2007
Last Updated
June 10, 2014
Sponsor
US Department of Veterans Affairs
Collaborators
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT00463853
Brief Title
Stem Cell Therapy as Adjunct to Revascularization
Acronym
STAR
Official Title
Stem Cell Therapy as Adjunct to Revascularization: STAR
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Why Stopped
inability to recruit due to administrative difficulties at the site
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
University of Utah

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
The experimental design will be a Phase I safety trial in which all subjects from the VA Salt Lake City Health Care System presenting with CAD and associated depressed LV function requiring myocardial surgical revascularization will be eligible for enrollment. Patients enrolled in the study will receive autologous BM-MNC as adjunct to CABG. The primary outcome measure will be safety as measured by the incidence of postoperative Serious Adverse Events (SAE) and Adverse Events (AE). The secondary outcome measures will be LV function, myocardial perfusion, and clinical improvement. The trial will have one experiment with one patient group. Group 1 (n=15) will follow standard Phase I dose escalation curve on a magnitude of 0.5 log increase after every third patient. Dose escalation will continue until a dosage of 1 x108 cells/pt is reached or maximum tolerated dose equivalent (MTDE) is identified. Cellular therapeutic products such as BM-MNCS do not possess the same pharmacologic profile as small molecule drugs, and thus, do not possess predictable metabolic activity and metabolite production, as do traditional pharmaceuticals. This can make the identity of a maximum tolerated dose somewhat difficult. We are therefore using the term MTDE instead of MTD to indicate a cell dosage that is consistent with clinical morbidity beyond obvious clinical benefit. The characteristics identifying a MTDE could be any adverse event felt to be related to the actual cell dosage or its escalation. Although unlikely, MTDE events could include microembolic phenomena, hematoma at the injection site, obvious myocardial congestion or ischemia at the injection site.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis, Coronary Artery Bypass Graft, Myocardial Revascularization
Keywords
Bone Marrow Cells, Cardiovascular Surgery, Coronary Artery Bypass Graft, Phase I Study, Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
direct intramyocardial injection of cells as adjunct to CABG
Intervention Type
Procedure
Intervention Name(s)
Autologous stem cell therapy
Intervention Type
Procedure
Intervention Name(s)
CABG
Intervention Type
Radiation
Intervention Name(s)
CMRI
Primary Outcome Measure Information:
Title
The primary outcome measure will be safety as measured by the incidence of postoperative serious adverse events (SAE) and adverse events (AE).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Ejection fraction measured by CMRI
Time Frame
at baseline, 3 & 6 months
Title
Echo
Time Frame
at baseline, intervention, 2 weeks, 1 month, 3 months, 6 months and 1 year
Title
Myocardial perfusion measured by gadolinium CMRI
Time Frame
at baseline, 3 & 6 months
Title
Exercise tolerance testing
Time Frame
at baseline, 1 month, 3 months, 6 months, and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Active history of alcohol or substance abuse Active psychiatric history leading to potential for poor study participation and follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Russell Reiss, MD
Organizational Affiliation
VA Salt Lake City Health Care System, Salt Lake City
Official's Role
Study Chair
Facility Information:
Facility Name
VA Salt Lake City Health Care System, Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States

12. IPD Sharing Statement

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Stem Cell Therapy as Adjunct to Revascularization

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