Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114452
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2005-06-14
Brief Title:
Safety Study of Adult Mesenchymal Stem Cells MSC to Treat Acute Myocardial Infarction
Sponsor:
Mesoblast Inc
Organization:
Mesoblast Ltd
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Placebo-controlled Dose Escalation Multicenter Study to Determine the Safety of Intravenous Ex-vivo Cultured Adult Human Mesenchymal Stem Cells Provacel Following Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2020-03
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:
None
Brief Summary:
The purpose of the study is to determine whether adult stem cells ProvacelPUMP1 are safe and possibly effective in the treatment of acute myocardial infarction heart attack
Detailed Description:
Cardiovascular disease is the single largest killer of males and females in the United States with an average of 335000 deaths per year This year an estimated 700000 Americans will suffer an acute myocardial infarction The standard of care treatment for acute myocardial infarction MI usually includes immediate perfusion optimal pain relief oxygen aspirin or other anti-coagulants Beta-Blockers nitrates and Ace-inhibitors Management of cardiac risk factors such as tobacco use hypertension lipid levels diabetes weight control and exercise all work to reduce further atherosclerotic events Yet many patients go on to develop Congestive Heart Failure CHF Medical management for CHF may improve symptoms and slow the progression to failure but does not restore a functioning myocardium A therapy that could improve the myocardial remodeling process and reduce the incidence or severity of CHF following acute MI would provide a significant benefit in an area of unmet medical need
Patients will receive standard of care in addition to stem cells or placebo
Patients will receive standard of care in addition to stem cells or placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None