Stem Cell Therapy as Adjunct to Revascularization

Status Withdrawn

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

Clinical Trial Details

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Status	Withdrawn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

View Details

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	`NCT00371891` - Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)	Phase 4
Completed	`NCT00368953` - YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus	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	`NCT00037245` - Androgens and Subclinical Atherosclerosis in Young Women - Ancillary to CARDIA	N/A
Completed	`NCT00024596` - Family Heart Study - Subclinical Atherosclerosis Network (FHS-SCAN)	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	`NCT00006502` - Myocardial Perfusion, Risk Factors, and Coronary Calcium	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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Stem Cell Therapy as Adjunct to Revascularization — STAR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms