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Combined CABG and Stem-Cell Transplantation for Heart Failure

NCT00418418 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-08-19

No results posted yet for this study

Summary

This is a prospective double blind trial of intraoperative transmyocardial bone marrow-derived mesenchymal cell transplantation vs placebo in patients with low left ventricular ejection fraction scheduled to coronary bypass operation.

Conditions

Interventions

PROCEDURE

Coronary bypass operation

Coronary bypass operation is performed via sternotomy during cardiac arrest.

PROCEDURE

Bone marrow aspiration (crista iliaca)

The bone marrow is aspirated from the iliac crest (100ml). During the operation the aspirate is transported to the stem cell laboratory, where the sample is centrifugated through Ficoll(Registered Trademark).

BIOLOGICAL

Intramyocardial mesenchymal stem cell transplantation

During the cardiac arrest, stem cells are directly injected to myocardium. The amount of the cells varies individually (5-1000 x 10e6 cells), the cells are diluted in autologous serum (5 ml)

BIOLOGICAL

Intramyocardial injection of autologous serum

Intramyocardial injection of autologous serum is injected during cardiac arrest

Sponsors & Collaborators

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Ari Harjula, MD; PhD · Department of Cardiothoracic Surgery, Helsinki University MeilahtiHospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00418418 on ClinicalTrials.gov