 - Patients presenting with medical disorder such as poorly controlled diabetes or arterial hypertension, severe cardiac insufficiency, unstable ischemic heart disease, abnormal liver function tests 2.5 times upper limit normal ULN and abnormal complete blood count in particular leukopenia, as defined by a lymphocyte count 500, neutrophil 1.5 or platelet count 100, or thrombocytopenia 1.5 low limit normal LLN, or any medical condition which, in the opinion of the chief investigator, would pose additional risk to the patient. 