Status:
WITHDRAWN
Cell Repair in Heart Failure
Lead Sponsor:
Imperial College London
Conditions:
Heart Failure
Ischemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Many people in the UK have ischaemic heart disease. Insufficient blood supply to the heart muscle means that it functions inefficiently, and leads to symptoms of shortness of breath, chest pain and ex...
Detailed Description
Study Objectives: 1. Evaluate the safety of a single administration of bone marrow mononuclear cells by retrograde coronary venous delivery. 2. Evaluate the bioactivity of bone marrow mononuclear cel...
Eligibility Criteria
Inclusion
- Symptomatic ischaemic multi-vessel coronary artery disease (CAD) not suitable for standard revascularization procedures such as CABG, PCI, LVAD, or heart transplant.
- Area of reversible inducible ischaemia (\>10% of LV on SPECT) performed not more than six months prior to study treatment.
- LVEF \< 45% on optimal medical therapy.
- NYHA class II- IV patient stable on optimal medical therapy for at least 30 days.
- Written informed consent and agree to attend hospital appointments for 1 year.
- Male and females 18 to 80 years of age.
Exclusion
- Left ventricular aneurysm or thrombus.
- Thoracic aortic aneurysm.
- Congenital Heart disease
- Acute unstable angina, idiopathic cardiomyopathy, life-threatening ventricular arrhythmias, recent (less than 6 weeks).
- Contraindication to MRI or any other study procedure.
- Presence or history of cancer (except low grade and fully resolved non-melanoma skin malignancy).
- Any co-morbidity likely to reduce short- term survival or which may interfere with functional testing.
- Recent myocardial infarction \< 6mths.
- Cerebral vascular accident \< 6mths.
- Active hepatitis, receiving immunosuppressive therapy, undergoing haemodialysis.
- Clinically significant abnormal haematology.
- Recent history of alcoholism, drug abuse, or severe emotional, behavioural, or psychiatric problems.
- Fertile women who are pregnant, nursing, or using no form of contraception.
- Receiving experimental medications or participating in another study within 12 weeks of enrolment into this study.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00285454
Start Date
January 1 2006
End Date
December 1 2008
Last Update
March 31 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Department of Gene Therapy, The National Heart and Lung Institute, Imperial College London and The Royal Brompton Hospital.
London, Middlesex, United Kingdom, SW3 6LR