Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04198883
Status:
WITHDRAWN
Last Update Posted:
2022-06-10
First Post:
2019-07-04
Brief Title:
SINGaporean Program Performed With an eXPANsion Medical Device SingXpand
Sponsor:
CellProthera
Organization:
CellProthera
Study Overview
Official Title:
SINGaporean Program Performed With an eXPANsion Medical Device
Status:
WITHDRAWN
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Because of the Impact of CoviD19 pandemy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SingXpand
Brief Summary:
The purpose of the pilot study is to evaluate the safety and the individual efficacy of the use of ProtheraCytes in patients with acute myocardial infarction and decreased ejection fraction CD34 cells will be re-injected using a dedicated catheter pushed through the femoral artery up to the left ventricle thus avoiding open chest surgery
Detailed Description:
Primary Objective The objective is to establish the safety of the interventional procedure beginning at the first G-CSF administration to 6 months after the injection of autologous expanded CD34 stem cells ProtheraCytes in AMI patients with a LVEF45 after PTCA and stents implantation
Secondary Objective The objective is to establish the individual efficacy of the interventional procedure beginning at the first G-CSF administration to 6 months after the injection of autologous expanded CD34 stem cells ProtheraCytes in AMI patients with a LVEF45 after PTCA and stents implantation
Secondary Objective The objective is to establish the individual efficacy of the interventional procedure beginning at the first G-CSF administration to 6 months after the injection of autologous expanded CD34 stem cells ProtheraCytes in AMI patients with a LVEF45 after PTCA and stents implantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None