Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration

• Sponsor: Hannover Medical School (Other)
• Overall Status: Completed
• CT.gov ID: NCT00224536
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 21
• Patients Per Site Per Month: 2.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Procedure: Intracoronary bone marrow cell transfer	Phase 1

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration-1
• Study Start Date: Jan 1, 2002
• Study Completion Date: Oct 1, 2003

Outcome Measures

Primary Outcome Measures

1. Left ventricular ejection fraction change between groups at month 6 []

Secondary Outcome Measures

1. Safety []

2. Left ventricular volumes []

3. Infarct size []

4. Subgroup analyses []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hannover Medical School	Hannover		Germany	30625

Sponsors and Collaborators

• Hannover Medical School

Investigators

• Principal Investigator: Helmut Drexler, MD, Hannover Medical School, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00224536
• Other Study ID Numbers: BOOST-1
• First Posted: Sep 23, 2005
• Last Update Posted: Sep 23, 2005
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: Myocardial infarction; Bone marrow cells; Intracoronary
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Sep 23, 2005