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Stem Cell Therapy as Adjunct to Revascularization (STAR)

This study has been terminated.
(inability to recruit due to administrative difficulties at the site)
Sponsor:
Collaborator:
University of Utah
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00463853
First received: April 17, 2007
Last updated: July 9, 2008
Last verified: July 2008
History of Changes
  Purpose

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).


Condition Intervention Phase
Coronary Arteriosclerosis
Coronary Artery Bypass Graft
Myocardial Revascularization
 Procedure: Autologous stem cell therapy
Procedure: CABG
Procedure: CMRI
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stem Cell Therapy as Adjunct to Revascularization: STAR

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

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). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ejection fraction measured by CMRI [ Time Frame: at baseline, 3 & 6 months ] [ Designated as safety issue: Yes ]
  • Echo [ Time Frame: at baseline, intervention, 2 weeks, 1 month, 3 months, 6 months and 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial perfusion measured by gadolinium CMRI [ Time Frame: at baseline, 3 & 6 months ] [ Designated as safety issue: Yes ]
  • Exercise tolerance testing [ Time Frame: at baseline, 1 month, 3 months, 6 months, and 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: August 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
direct intramyocardial injection of cells as adjunct to CABG
 Procedure: Autologous stem cell therapy Procedure: CABG Procedure: CMRI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463853

Locations
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
Department of Veterans Affairs
University of Utah
Investigators
Study Chair: G. Russell Reiss, MD VA Salt Lake City Health Care System, Salt Lake City
  More Information

Publications:

Responsible Party: Reiss, G. Russell - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00463853     History of Changes
Other Study ID Numbers: CLNB-017-04S
Study First Received: April 17, 2007
Last Updated: July 9, 2008
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
Bone Marrow Cells
Cardiovascular Surgery
Coronary Artery Bypass Graft
Phase I Study
Stem Cells

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases

ClinicalTrials.gov processed this record on June 17, 2013