Selected autologous bone marrow cell transplant following trans-mural myocardial infarction in patients undergoing coronary surgery: A prospective, double-blind, randomised controlled trial

ISRCTN	ISRCTN65630838
DOI	https://doi.org/10.1186/ISRCTN65630838
Protocol serial number	Sponsor ref: CS/2005/2031
Sponsor	United Bristol Healthcare NHS Trust (UK)
Funder	British Heart Foundation (UK)

Submission date: 01/05/2008
Registration date: 10/07/2008
Last edited: 04/04/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Raimondo Ascione
Scientific

Level 7, Research Floor
University of Bristol
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Study information

Primary study design	Interventional
Study design	Double-blind, randomised, placebo-controlled trial.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	TransACT
Study objectives	The transplantation of bone marrow derived CD133+ autologous stem cells in and around large asynergic scarred areas of the heart will induce neoangiogenesis and neomyogenesis restoring local viability and contractility. CD133+ transplantation may also prevent left ventricular (LV) remodelling, improving mid-term quality of life in patients with ischemic non-dilated cardiomyopathy undergoing coronary surgery.
Ethics approval(s)	NHS Southmead Research Ethics Committee (ref: 05/Q2002/50). Date of approval: 20/07/2005. Amendment approved on 06/08/2007.
Health condition(s) or problem(s) studied	Cardiac disease/ coronary surgery
Intervention	Experimental intervention: Injection of enriched autologous CD133+ stem cells derived from bone marrow, suspended in autologous plasma Comparator intervention: Injection of autologous plasma Please use the following contact details to request a patient information sheet: Dr Jodi Taylor Clinical Trials Co-ordinator Bristol Heart Institute University of Bristol Level 7, Bristol Royal Infirmary Bristol BS2 8HW, UK Tel: +44 (0)117 928 3398 Email: j.taylor@bristol.ac.uk
Intervention type	Other
Primary outcome measure(s)	Regional LV thickening of the injected segments of the left ventricle 6 months after surgery measured by cardiac MRI. The use of MRI will also allow us to ascertain the reasons for any observed changes in wall thickening at the injected sites at 6 months by comparing the transmural distribution of viable myocardium and scar before and after surgery.
Key secondary outcome measure(s)	The following outcomes will be measured pre-operatively and at 6 months after surgery: 1. Scar distribution and the viability of the myocardium with MRI 2. LV segmental and global function with echocardiography 3. Mid-term generic and cardiac specific health status and quality of life. These will be assessed by the disease-specific Coronary Revascularisation Outcome Questionnaire, the Minnesota Living with Heart Failure Questionnaire and the 36-item Short Form health survey (SF-36) 4. Myocardial injury throughout the entire study period by measuring troponin I levels
Completion date	01/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Patients of either sex, aged 16 years or over and under 80 years 2. Recent (>10 days and 3 months) anterior ST-Segment Elevation Myocardial Infarction (STEMI) who have not undergone primary angioplasty 3. Cardiac magnetic resonance imaging (MRI) documented anterior myocardial infarction (MI) with a transmurality of >= 50% wall thickness in at least 1 segment of the LAD territory 4. Requirement for coronary artery bypass graft (CABG) alone to bypass stenoses or occlusions of the left anterior descending artery (LAD) territory and any other territory as dictated by baseline coronary angiography 5. Absence of LV dilation (LV end systolic volume index <60 ml/m^2)
Key exclusion criteria	1. Presence of cardiogenic shock or presence of acute left and/or right-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema 2. Cardiac MRI documented MI transmurality of <50% wall thickness in all 7 segments of the LAD territory 3. Presence of LV dilatation (LV end systolic volume index >60 ml/m^2) 4. Cardiomyopathy secondary to a reversible cause 5. Known active infection 6. Chronic inflammatory disease 7. Serum creatinine >= 200 mmol/L 8. Contraindications for bone marrow aspiration 9. Female subjects of childbearing potential 10. Emergency operation for unstable angina 11. History of pace-maker or defibrillator insertion
Date of first enrolment	01/06/2008
Date of final enrolment	01/03/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Level 7, Research Floor

Bristol
BS2 8HW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes