Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416663
Status:
UNKNOWN
Last Update Posted:
2007-09-03
First Post:
2006-12-27
Brief Title:
VescellTM for the Treatment of Patients With Severe Anginal Syndrome With or Without Heart Failure
Sponsor:
TheraVitae Ltd
Organization:
TheraVitae Ltd
Study Overview
Official Title:
A Study for Testing Efficacy and Safety of the Administration of VescellTM Blood-Borne Autologous Angiogenic Cell Precursors to Alleviate Anginal Symptoms and Myocardial Ischemia in Severe Anginal Syndrome - Heart Failure
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of an intracoronary injection of ex-vivo generated autologous Angiogenic Cells Precursors ACPs to treat patients suffering from severe angina not responsive to maximal drug treatment or not willing or without option of undergoing percutaneous coronary intervention PCI or coronary artery bypass graft surgery CABG The use of ACPs aims to promote the formation of new vascularization and thus viable myocardial tissue
Detailed Description:
Ten adult patients with severe angina pectoris with or without heart failure and no therapeutic alternative will undergo screening and be treated with an injection of Angiogenic Cell Precursors ACPs contained in VesCell TM 250 ml of blood will be drawn from the patient and from this blood sample progenitor cells will be generated and differentiated into ACPs The product will be administered into the obstructed coronary arteries using a catheter Following injection patients will be hospitalized for 24-48 hours in intensive care and later as required by their medical condition Patients will return for follow up testing at one three and six months following treatment
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