Efficacy of the mode of delivery of autologous bone marrow cells into heart scar muscle for the recovery of contractile function

ISRCTN	ISRCTN47591706
DOI	https://doi.org/10.1186/ISRCTN47591706
Secondary identifying numbers	N0523154398

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Francisco Leyva
Scientific

Consultant Cardiologist
Good Hope Hospital NHS Trust
Rectory Road
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	07/04/2004
Completion date	07/04/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Not Specified
Target number of participants	Estimated 30 patients per group
Key inclusion criteria	Patients undergoing coronary bypass graft surgery aged between 18 and 80. Estimated 30 patients per group in order to detect significance
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	07/04/2004
Date of final enrolment	07/04/2007

Consultant Cardiologist

Birmingham
B75 7RR
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Good Hope Hospital NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2008		Yes	No