Ignite Creation Date:
2024-05-06 @ 8:04 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02669810
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2016-01-25
Brief Title:
EXCELLENT EXpanded CELL ENdocardiac Transplantation
Sponsor:
CellProthera
Organization:
CellProthera
Study Overview
Official Title:
EXpanded CELL ENdocardiac Transplantation EXCELLENT
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
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:
EXCELLENT
Brief Summary:
A multicentric controlled phase I IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34 stem cells output by the StemXpand Automated Process and injected in patients with an acute myocardial infarction and a LVEF remaining below 50 versus standard of care
Detailed Description:
The main purpose of this phase IIIb is to evaluate the safety the tolerance and the first efficacy trends of intracardiac injection of ProtheraCytes autologous PB-CD34 Stem Cells after automated ex-vivo expansion with the StemXpand machine in patients with an acute myocardial infarction and decreased ejection fraction ProtheraCytes will be reinjected using a dedicated catheter thus avoiding open chest surgery
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