A Phase 1 interventional study of Autologous stem cell therapy and CABG in Coronary Arteriosclerosis, Coronary Artery Bypass Graft and Myocardial Revascularization, sponsored by US Department of Veterans Affairs. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-11.
Sponsored by US Department of Veterans Affairs · Phase 1, Interventional, and Treatment
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).
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.
317 studies on the registry are indexed under Arteriosclerosis; 33 are open to participants now.
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Class I
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)
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)
Exclusion Criteria:
direct intramyocardial injection of cells as adjunct to CABG
Procedure: Autologous stem cell therapy · Procedure: CABG · Radiation: CMRI
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
Ejection fraction measured by CMRI
Time frame: at baseline, 3 & 6 months
Echo
Time frame: at baseline, intervention, 2 weeks, 1 month, 3 months, 6 months and 1 year
Myocardial perfusion measured by gadolinium CMRI
Time frame: at baseline, 3 & 6 months
Exercise tolerance testing
Time frame: at baseline, 1 month, 3 months, 6 months, and 1 year
This study is withdrawn, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs