Bone-marrow derived stem cell transplantation in patients undergoing left ventricular restoration surgery for dilated ischaemic end-stage heart failure
| ISRCTN | ISRCTN71717097 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71717097 |
| Protocol serial number | CS/2008/3027 |
| Sponsor | University Hospitals Bristol NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Biomedical Research Unit |
- Submission date
- 27/07/2009
- Registration date
- 14/10/2009
- Last edited
- 12/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Level 7, Research Floor
University of Bristol
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
| R.Ascione@bristol.ac.uk |
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 | Bone-marrow derived stem cell transplantation in patients undergoing left ventricular restoration surgery for dilated ischaemic end-stage heart failure: a randomised blinded controlled trial |
| Study acronym | TransACT 2 |
| Study objectives | The aim of this study is to determine the effects of CD133+ autologous stem cells transplantation in and around asynergic non-viable left ventricular (LV) segments in patients with dilated ischaemic heart disease undergoing left ventricular reshaping surgery and coronary artery bypass graft (CABG). |
| Ethics approval(s) | NHS Southmead Research Ethics Committee, 20/07/2005, ref: 05/K2002/49 |
| Health condition(s) or problem(s) studied | Cardiac disease/coronary surgery |
| Intervention | Eligible patients undergoing SVR surgery will be allocated to either: 1. Intervention group: SVR surgery and transplantation of autologous CD133+ 2. Control group: SVR surgery and injection of placebo, i.e. autologous plasma Please use 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 United Kingdom Tel: +44 (0)117 342 3398 Email: j.taylor@bristol.ac.uk |
| Intervention type | Other |
| Primary outcome measure(s) |
Regional LV thickening of the 'affected' segments 6 months after surgery, i.e. end systolic thickness minus end diastolic thickness (millimetres). Affected segments will be those scored on the cardiac MRI taken 3 - 5 days after surgery, as 1 - 5 (dysfunctional) on a 5-point scale. Affected segments will be the segments which the surgeons aims to inject with stem cells or plasma. Measured at baseline (3 - 5 days post-operatively) and 6 months follow-up. |
| Key secondary outcome measure(s) |
1. Mid-term generic and cardiac-specific health status and quality of life, measured at baseline and 6 months follow-up |
| Completion date | 01/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Previous anterior myocardial infarction (with evidence of large surgically excludible scar at cardiac magnetic resonance imaging [MRI]) 2. Significant LV dilation (left ventricular end-systolic volume index [LVESVI] greater than or equal to 60 ml/m^2 3. Left ventricular ejection fraction less than or equal to 35% 4. New York Heart Association (NYHA) class III/IV and one episode of congestive heart failure (CHF) requiring medical attention 5. Elective left ventricular restoration surgery indicated 6. Elective CABG indicated to bypass stenoses or occlusions of coronary arteries 7. Patient aged 16 years or over and under 80 years old, either sex |
| Key exclusion criteria | 1. Severe acute renal failure requiring dialysis or serum creatinine greater than or equal to 200 mmol/L 2. Atrial fibrillation 3. Malignancy 4. Debilitating neurological disease 5. Emergency operation for unstable angina 6. Previous cardiac surgery/sternotomy 7. Concomitant valve procedures 8. History of significant ventricular arrhythmias 9. History of pacemaker and/or defibrillator insertion 10. Right ventricular (RV) failure 11. Pulmonary hypertension greater than 60 mmHg (angiogram or Elixis) 12. Known active infection 13. Chronic inflammatory disease 14. Contraindication for bone marrow aspiration 15. Female subjects of childbearing potential |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 01/02/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
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 |
Editorial Notes
12/04/2017: No publications found in PubMed, verifying study status with principal investigator.
