Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224536
Status:
COMPLETED
Last Update Posted:
2005-09-23
First Post:
2005-09-21
Brief Title:
Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration-1
Status:
COMPLETED
Status Verified Date:
2005-09
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:
After successful percutaneous coronary intervention PCI for acute ST-segment elevation myocardial infarction 60 patients were randomly assigned to either a control group n30 that received optimum postinfarction medical treatment or a bone-marrow-cell group n30 that received optimum medical treatment and intracoronary transfer of autologous bone-marrow cells 48 days SD 13 after PCI Primary endpoint was global left-ventricular ejection fraction LVEF change from baseline to 6 months follow-up as determined by cardiac MRI Image analyses were done by two investigators blinded for treatment assignment Analysis was per protocol
Global LVEF at baseline determined 35 days SD 15 after PCI was 513 93 in controls and 500 100 in the bone-marrow cell group p059 After 6 months mean global LVEF had increased by 07 percentage points in the control group and 67 percentage points in the bone-marrow-cell group P00026
Transfer of bone-marrow cells enhanced left-ventricular systolic function primarily in myocardial segments adjacent to the infarcted area Cell transfer did not increase the risk of adverse clinical events in-stent restenosis or proarrhythmic effects
Global LVEF at baseline determined 35 days SD 15 after PCI was 513 93 in controls and 500 100 in the bone-marrow cell group p059 After 6 months mean global LVEF had increased by 07 percentage points in the control group and 67 percentage points in the bone-marrow-cell group P00026
Transfer of bone-marrow cells enhanced left-ventricular systolic function primarily in myocardial segments adjacent to the infarcted area Cell transfer did not increase the risk of adverse clinical events in-stent restenosis or proarrhythmic effects
Detailed Description:
Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction In this randomised trial we aimed to assess whether intracoronary transfer of autologous bone-marrow cells could improve global left-ventricular ejection fraction LVEF at 6 months follow-up
After successful percutaneous coronary intervention PCI for acute ST-segment elevation myocardial infarction 60 patients were randomly assigned to either a control group n30 that received optimum postinfarction medical treatment or a bone-marrow-cell group n30 that received optimum medical treatment and intracoronary transfer of autologous bone-marrow cells 48 days SD 13 after PCI Primary endpoint was global left-ventricular ejection fraction LVEF change from baseline to 6 months follow-up as determined by cardiac MRI Image analyses were done by two investigators blinded for treatment assignment Analysis was per protocol
Global LVEF at baseline determined 35 days SD 15 after PCI was 513 93 in controls and 500 100 in the bone-marrow cell group p059 After 6 months mean global LVEF had increased by 07 percentage points in the control group and 67 percentage points in the bone-marrow-cell group P00026
Transfer of bone-marrow cells enhanced left-ventricular systolic function primarily in myocardial segments adjacent to the infarcted area Cell transfer did not increase the risk of adverse clinical events in-stent restenosis or proarrhythmic effects Intracoronary transfer of autologous bone-marrow-cells promotes improvement of left-ventricular systolic function in patients after acute myocardial infarction
After successful percutaneous coronary intervention PCI for acute ST-segment elevation myocardial infarction 60 patients were randomly assigned to either a control group n30 that received optimum postinfarction medical treatment or a bone-marrow-cell group n30 that received optimum medical treatment and intracoronary transfer of autologous bone-marrow cells 48 days SD 13 after PCI Primary endpoint was global left-ventricular ejection fraction LVEF change from baseline to 6 months follow-up as determined by cardiac MRI Image analyses were done by two investigators blinded for treatment assignment Analysis was per protocol
Global LVEF at baseline determined 35 days SD 15 after PCI was 513 93 in controls and 500 100 in the bone-marrow cell group p059 After 6 months mean global LVEF had increased by 07 percentage points in the control group and 67 percentage points in the bone-marrow-cell group P00026
Transfer of bone-marrow cells enhanced left-ventricular systolic function primarily in myocardial segments adjacent to the infarcted area Cell transfer did not increase the risk of adverse clinical events in-stent restenosis or proarrhythmic effects Intracoronary transfer of autologous bone-marrow-cells promotes improvement of left-ventricular systolic function in patients after acute myocardial infarction
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