A Phase I/II safety and tolerability dose escalation study following the autologous infusion of expanded adult haematopoietic stem cells to patients with established myocardial ischaemia.
- Conditions
- Established myocardial ischaemia
- Registration Number
- EUCTR2006-000280-28-GB
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Male or female 40 years or over
Documented localised area of myocardial dysfunction within the left ventricular wall
Infarct area should be supplied by non-occluded coronary arterial network
Patients should have had a recent coronary angiogram within previous 6 months
Clinical signs and symptoms of ischaemia or heart failure
Have a normal blood count and normal coagulation parameters on screening
Have a life expectancy of greater than 12 months
Subjects must no longer be capable of reproduction or use a reliable and appropriate contraceptive method during the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients below the age of 40 years
Patients with a history of hypersensitivity to therapeutic proteins
Subjects requiring revascularisation on an urgent basis
Subjects with a target coronary artery stenosis greater than 50%
Patients undergoing surgery for concomitant cardiac procedures
Patients with severe co-morbidity associated with a reduction in life expectancy to less than 1 year
Patients with the lack of ability to obtain vascular access for percutaneous procedures
Patients with left ventricular aneurysm or with underlying rythm disturbances
Pregnant or lactating women
Patients with unexplained abnormal baseline laboratory parameters
Males or females who are capable of reproduction but who will not take acceptable measures to prevent reproduction during the study.
Subjects who test positive for HIV, Hepatitis B or C or who have chronic inflammatory disease, autoimmune disease or who are on chronic immunosuppressive medications
Patients with a history of alcohol or drug abuse within 3 months of screening
Patients with evidence (clinical, laboratory or imaging) of cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in-situ cervical carcinoma)
Patients currently enrolled in another investigational device or drug trial that has not completed the required follow-up period
Persons unable to give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method