Ignite Creation Date:
2024-05-06 @ 12:07 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01495364
Status:
COMPLETED
Last Update Posted:
2016-04-28
First Post:
2011-12-09
Brief Title:
NBS10 Also Known as AMR-001 Versus Placebo Post ST Segment Elevation Myocardial Infarction
Sponsor:
Lisata Therapeutics Inc
Organization:
Lisata Therapeutics Inc
Study Overview
Official Title:
A Prospective Randomized Double Blind Placebo Controlled Phase II Trial of Intra-coronary Infusion of AMR-001 a Bone Marrow Derived Autologous CD34 Selected Cell Product in Patients With Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2016-04
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:
PreSERVE-AMI
Brief Summary:
This study will assess the safety and efficacy of intracoronary artery administered autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial infarction STEMI This will be assessed by evaluating and comparing the autologous stem cell treatment group to the control group in terms of the occurrence of AEs SAEs and Major Adverse Cardiac Events MACE by the change in myocardial perfusion RTSS measured quantitatively by gated single photon emission computed tomography myocardial perfusion imaging gated SPECT MPI and other secondary endpoints such as LVEF measured by cardiac MRI in addition to other endpoints
Detailed Description:
Efficacy endpoint is at 6 months Clinical endpoints and safety will be measured through 36 months
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