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Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Intracoronary bone marrow cell transfer
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Myocardial infarction, Bone marrow cells, Intracoronary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients were eligible if they were admitted within 5 days of the onset of symptoms of a first ST-segment elevation myocardial infarction Had undergone successful PCI with stent implantation in the infarctrelated artery Had hypokinesia or akinesia involving more than two thirds of the left-ventricular anteroseptal, lateral, and/or inferior wall, as shown by angiography done immediately after PCI. Exclusion Criteria: We excluded patients who had multivessel coronary artery disease, pulmonary edema, cardiogenic shock, advanced renal or hepatic dysfunction, or documented terminal illness or cancer.

Sites / Locations

  • Hannover Medical School

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction change between groups at month 6

Secondary Outcome Measures

Safety
Left ventricular volumes
Infarct size
Subgroup analyses

Full Information

First Posted
September 21, 2005
Last Updated
September 21, 2005
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00224536
Brief Title
Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration
Official Title
Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration-1
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hannover Medical School

4. Oversight

5. Study Description

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 (n=30) that received optimum postinfarction medical treatment, or a bone-marrow-cell group (n=30) that received optimum medical treatment and intracoronary transfer of autologous bone-marrow cells 4·8 days (SD 1·3) 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 3·5 days [SD 1·5] after PCI) was 51·3 (9·3%) in controls and 50·0 (10·0%) in the bone-marrow cell group (p=0·59). After 6 months, mean global LVEF had increased by 0·7 percentage points in the control group and 6·7 percentage points in the bone-marrow-cell group (P=0·0026). 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 (n=30) that received optimum postinfarction medical treatment, or a bone-marrow-cell group (n=30) that received optimum medical treatment and intracoronary transfer of autologous bone-marrow cells 4·8 days (SD 1·3) 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 3·5 days [SD 1·5] after PCI) was 51·3 (9·3%) in controls and 50·0 (10·0%) in the bone-marrow cell group (p=0·59). After 6 months, mean global LVEF had increased by 0·7 percentage points in the control group and 6·7 percentage points in the bone-marrow-cell group (P=0·0026). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Myocardial infarction, Bone marrow cells, Intracoronary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Intracoronary bone marrow cell transfer
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction change between groups at month 6
Secondary Outcome Measure Information:
Title
Safety
Title
Left ventricular volumes
Title
Infarct size
Title
Subgroup analyses

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients were eligible if they were admitted within 5 days of the onset of symptoms of a first ST-segment elevation myocardial infarction Had undergone successful PCI with stent implantation in the infarctrelated artery Had hypokinesia or akinesia involving more than two thirds of the left-ventricular anteroseptal, lateral, and/or inferior wall, as shown by angiography done immediately after PCI. Exclusion Criteria: We excluded patients who had multivessel coronary artery disease, pulmonary edema, cardiogenic shock, advanced renal or hepatic dysfunction, or documented terminal illness or cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Drexler, MD
Organizational Affiliation
Hannover Medical School, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15246726
Citation
Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H. Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial. Lancet. 2004 Jul 10-16;364(9429):141-8. doi: 10.1016/S0140-6736(04)16626-9.
Results Reference
result

Learn more about this trial

Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration

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