Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration

NCT00224536 | Completed Phase 1

• 1 other identifier: BOOST-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Myocardial infarction; Bone marrow cells; Intracoronary

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction change between groups at month 6

Secondary Outcomes (4)

• Safety

• Left ventricular volumes

• Infarct size

• Subgroup analyses

Interventions

Intracoronary bone marrow cell transfer PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• We excluded patients who had multivessel coronary artery disease, pulmonary edema, cardiogenic shock, advanced renal or hepatic dysfunction, or documented terminal illness or cancer.

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (1)

• 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.

  PMID: 15246726 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Helmut Drexler, MD

  Hannover Medical School, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: January 1, 2002
• Study Completion: October 1, 2003
• Last Updated: September 23, 2005

Record last verified: 2005-09

Locations

DE (1)