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.

Imperial College London0 个研究点目标入组 40 人开始时间: 2006年5月10日最近更新: 2019年6月30日

试验速览

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•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

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