E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Established myocardial ischaemia |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
Assessment of clinical improvement or deterioration by measurement of clinical parameters such as left ventricular dimensions |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
No evidence of adverse effects directly atrributable to the medicinal product |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |