Healthy subjects
Conditions
Interventions
After obtaining written consent from the research subjects at an outpatient clinic of the National Defense Medical College Hospital two to eight weeks prior to the date of peripheral blood stem cell c
C088327
Plerixafor
Sponsors
Maekawa Takaaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects who have received a full explanation of their participation in this study and who have given their free and voluntary written consent based on a full understanding of the study. (2) Subjects who are at least 18 years old and less than 54 years old and in good health. (3) Men weighing 45 kg or more/women weighing 40 kg or more, and weighing less than 100 kg.
Exclusion criteria
Exclusion criteria: (1) Subjects undergoing treatment for illness or injury or using prescription drugs *Including those taking antihypertensive medications for high blood pressure, those taking medications for chronic diseases such as bronchial asthma, active infectious diseases such as viruses, bacteria, and parasites, chronic infectious diseases such as tuberculosis and non-tuberculous mycobacterial lung disease, those taking medications for mental illnesses, and those visiting the hospital. *Excludes colds, hay fever, and other conditions that are transient and require treatment, and that can be cured in a short period of time. *Excludes internal use of supplements such as nutritional supplements. (2) Subjects with a history of the following diseases *Hematological diseases such as malignant tumors, leukemia, and aplastic anemia; collagen diseases; autoimmune diseases; cardiovascular diseases such as congenital heart disease, myocardial infarction, and angina pectoris; stroke; blood borne infectious diseases such as Hepatitis B virus, hepatitis C virus, human immunodeficiency virus, Treponema pallidum, human T-cell leukaemia virus and malaria. (3) High blood pressure (maximum blood pressure of 151 mmHg or higher / minimum blood pressure of 101 mmHg or higher) or low blood pressure (maximum blood pressure of less than 90 mmHg) (4) Subjects with anemia (hemoglobin level: less than 13.0 g/dL in men, less than 12.0 g/dL in women) (5) Persons with thrombocytopenia (less than 150,000/ul) (6) Subjects who have ever experienced symptoms such as breathing difficulties due to allergy to food, medicine, etc., or have a history of severe rash (7) Women who are pregnant or may become pregnant (8) Women of childbearing potential who cannot agree to use contraception during administration of this drug and for 1 week after the last dose. (9) Breastfeeding women (10) Patients with renal dysfunction (eGFR 36.0 mL/min/1.73 m2 or less) (11) Those who cannot identify veins of sufficient size in both upper extremities (12) Other persons who are judged by the physician to be ineligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of CD34-positive stem cells per subject body weight recovered by a single peripheral blood stem cell collection 4 hours after plerixafol administration | — |
Secondary
| Measure | Time frame |
|---|---|
| *Correlation with the estimated yield by applying the previously reported prediction equation *Calculation of target blood throughput *Percentage of adverse events | — |
Contacts
Public ContactTakaaki Maekawa
National Defense Medical College Hospital
Outcome results
None listed