Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00463853
Study type Interventional
Source VA Office of Research and Development
Contact
Status Withdrawn
Phase Phase 1
Start date August 2007
Completion date October 2009

See also
  Status Clinical Trial Phase
Completed NCT00069654 - Dietary Nitrate and Nitrite to Increase Nitric Oxide in Patients With Coronary Artery Disease Phase 2
Completed NCT02919124 - Epicardial Echocardiography of Coronary Anastomoses Using the Echoclip Device N/A
Recruiting NCT02639962 - Characteristics of Culprit Lesion and Changes in Plaque Composition. A Dual Energy Cardiac CT Study N/A
Completed NCT02494557 - Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients N/A
Recruiting NCT01466452 - Antiplatelet Effect of Low Doses of Aspirin Taken Every 12 Hours in Patients Undergoing Coronary Artery Bypass Graft and/or Aortic Valve Surgery Phase 2
Completed NCT01182428 - XIENCE V: SPIRIT WOMEN Sub-study Phase 4
Completed NCT00368953 - YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus Phase 4
Completed NCT00371891 - Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS) Phase 4
Completed NCT00319449 - Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED) Phase 4
Completed NCT00091754 - Atherosclerosis, Plaque and CVD in Communities
Completed NCT00069797 - Epidemiology of Coronary Heart Disease in Men Aged 40 and Over N/A
Completed NCT00024596 - Family Heart Study - Subclinical Atherosclerosis Network (FHS-SCAN) N/A
Completed NCT00037245 - Androgens and Subclinical Atherosclerosis in Young Women - Ancillary to CARDIA N/A
Completed NCT00006502 - Myocardial Perfusion, Risk Factors, and Coronary Calcium N/A
Withdrawn NCT00006497 - Long-Term Effects of Subclinical CAD on Cardiac Function
Completed NCT00006407 - Sex Steroid Hormones and Risk of CHD in Women N/A
Completed NCT00006309 - Pooling of Cohort Studies on Diet & Coronary Disease N/A
Completed NCT00005269 - Family Blood Pressure Program - GENOA
Completed NCT00000508 - Stanford Coronary Risk Intervention Project (SCRIP) Phase 3
Completed NCT00005147 - Epidemiology of Atherosclerosis N/A