High Dose of Intravenous Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells (CLV-100) Infusion Displays Better Immunomodulatory Effect among Healthy Volunteers: A Phase 1 Clinical Study
Table 1
Key inclusion and exclusion criteria for the enrolled subjects.
Key inclusion criteria
(i) Men and women aged 40 years and older (ii) Subjects with normoglycemia (iii) Subjects with normotension (iv) Subjects with normal fasting lipid profile (v) Subject must understand patient information sheet and signed informed consent form
Key exclusion criteria
(i) Subject who has enrolled in another investigational drug trial or innovative therapeutics product-related trial or has completed the aforesaid within 3 months (ii) Subject with history of current or past use (within 1 year) of alcohol, smoking, or drug abuse (iii) Pregnant or nursing women (iv) Subject with known documented drug allergies (v) Subject who is required of the following medicines on a regular basis: anti-histamine, steroid, antibiotic, anti-inflammatory, immunosuppressant, and pain killer medications (vi) Subject who is currently on any hormone replacement or hormone suppressive therapy for any indication (vii) Subject with any acute or chronic infections or communicable diseases including hepatitis B, hepatitis C, or HIV (viii) Subject with any active or past history of neoplasia and primary hematological disease (ix) Subject with any renal impairment indicated by serum creatinine ≥120 μmol or creatinine clearance <60 mL/min (x) Subject with any cardiovascular disease including documented coronary disease of more than 50% stenosis, angina, myocardial infarction, heart failure, stroke, transient ischemic attack, and/or peripheral artery disease (xi) Subject with any diabetes mellitus (xii) Subject with any liver impairment indicated by serum aspartate transaminase and alanine transaminase greater than 1.5 times upper limit normal (xiii) Subject with any chronic pulmonary or airways disease (xiv) Subject with any current or past history of mental illness or cognitive impairment.
