Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463853
Status:
WITHDRAWN
Last Update Posted:
2014-06-11
First Post:
2007-04-17
Brief Title:
Stem Cell Therapy as Adjunct to Revascularization
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Stem Cell Therapy as Adjunct to Revascularization STAR
Status:
WITHDRAWN
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inability to recruit due to administrative difficulties at the site
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
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 n15 will follow standard Phase I dose escalation curve on a magnitude of 05 log increase after every third patient Dose escalation will continue until a dosage of 1 x108 cellspt 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None