Ignite Creation Date:
2024-05-05 @ 10:46 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01187654
Status:
COMPLETED
Last Update Posted:
2012-12-27
First Post:
2010-08-18
Brief Title:
Bone Marrow Derived AC 133 and Mono-Nuclear Cells MNC Implantation in Myocardial Infarction MI Patient
Sponsor:
Royan Institute
Organization:
Royan Institute
Study Overview
Official Title:
Comparison the Therapeutic Outcomes of Bone Marrow Derived AC 133 and Mono-Nuclear Cells MNC Implantation in Patient With Acute Myocardial Infarction Underwent PCI Procedure
Status:
COMPLETED
Status Verified Date:
2010-08
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:
Although a percutaneous coronary intervention PCI can be used to open up the blocked artery and restore blood flow to the heart muscle after myocardial infarction there may be a significant amount of heart tissue that has been irreversibly damaged Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function and prevent from heart remodeling due to heart failure
This study will evaluate the safety and effectiveness of using adult bone marrow derived stem cells for improving heart function in MI patients with Left Anterior Descending LAD involvement
This study will evaluate the safety and effectiveness of using adult bone marrow derived stem cells for improving heart function in MI patients with Left Anterior Descending LAD involvement
Detailed Description:
Patient from both gender who had acute MI within recent 3 Weeks in LAD territory and would underwent PCI are eligible for this study The bone marrow derived AC 133 and MNC would be intracoronary injected to the patients during PCI procedure The control group would be received just serum during PCI The patient would be followed every month and at the end of 6th and 18thmonth the case and control groups will be evaluated by stress echo and Tc99 scan
The totality of evidence from trials investigating autologous whole bone marrow infusion into patients following myocardial infarction supports the safety of this approach in terms of efficacy
The totality of evidence from trials investigating autologous whole bone marrow infusion into patients following myocardial infarction supports the safety of this approach in terms of efficacy
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