Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0523154398
Study information
Scientific title
Acronym
Study hypothesis
Study the efficacy of the intravascular as compared to intramuscular administration of autologous bone marrow in the reduction of scar tissue in the heart muscle and in the improvement of segmental contactile function
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Coronary artery bypass grafting (CABG)
Intervention
[A] Control group receiving only myocardial revascularisation
[B] Direct injection into the scar muscle of self bone marrow mononuclear cells in addition to myocardial revascularisation
[C] Intravascular administration of self bone marrow into the graft used for myocardial revascularisation
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Functional improvement, and reduction in size of scar areas. The study will also establish whether the number and the type of transplanted bone marrow mononuclear cells is correlated with the recovery of contractile function by performing multiple linear regression analysis.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
07/04/2004
Overall trial end date
07/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing coronary bypass graft surgery aged between 18 and 80. Estimated 30 patients per group in order to detect significance
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Estimated 30 patients per group
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
07/04/2004
Recruitment end date
07/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Cardiologist
Birmingham
B75 7RR
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Good Hope Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18711405
Publication citations
-
Results
Ang KL, Chin D, Leyva F, Foley P, Kubal C, Chalil S, Srinivasan L, Bernhardt L, Stevens S, Shenje LT, Galiñanes M, Randomized, controlled trial of intramuscular or intracoronary injection of autologous bone marrow cells into scarred myocardium during CABG versus CABG alone., Nat Clin Pract Cardiovasc Med, 2008, 5, 10, 663-670, doi: 10.1038/ncpcardio1321.