Established myocardial ischaemia
Conditions
Interventions
Product Name: Expanded haematopoietic stem cells
Product Code: HHSC/002
Pharmaceutical Form: Suspension for injection
Current Sponsor code: HHSC/002
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of an infusion of expanded autologous stem cells up to a concentration of 2 x 10 to the 8 total cells.;Secondary Objective: Assessment of clinical improvement or deterioration by measurement of clinical parameters such as left ventricular dimensions;Primary end point(s): No evidence of adverse effects directly atrributable to the medicinal product | — |
Countries
United Kingdom
Outcome results
None listed