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 2

Clinical characteristics in recruited subjects during baseline assessment.

Parameter	Normal range	Total ()	Low dose ()	High dose ()	value^a
Age	—				0.36
Body weight	—				0.15
Male	—	4	2	2	0.82
Female	—	7	3	4	0.82
Routine blood tests
WBC (×10^9/L)	4.0-11.0				0.03
Hemoglobin (g/dL)	11.5-16.5				0.20
HCT (%)	35-47				0.41
MCV (fl)	76-96				0.52
Platelet (×10^9/L)	150-400				0.72
Creatinine (μmol/L)	44-97				0.36
ESR (mm/hr)	0-20				0.86
AST (IU/L)	0-40				0.27
ALT (IU/L)	0-53				0.52
Albumin (g/L)	30-50				0.58
Globulin (g/L)	20-50				0.46
A/G ratio	1.2-2.5				0.40
Total cholesterol (mmol/L)	<5.2				0.71
HbA1c (%)	3.0-6.0				0.07
FBS (mmol/L)	3.9-5.6				0.93
Insulin (mU/L)	3.0-25.0				1.00
IGF-1(ng/mL)	87-238				0.88
DHEAS (μmol/L)	1.0-11.7				0.10
Estradiol (pg/mL)	50-100				0.83
Progesterone (ng/mL)	0.57-6.11				0.82
Testosterone (ng/mL)	2.41-8.27		-^b		-^b
hs-CRP (mg/L)	<4.7				0.58
IgE (IU/mL)	<158.0				0.48
Total PSA (ng/mL)	0.0-4.0				0.12
CA125 (U/mL)	<35.0				0.08
CA15.3 (U/mL)	<28.0				0.72
CEA (ng/mL)	<5.0				1.00
CA19.9 (U/mL)	<37.0				0.36
AFP (ng/mL)	<15.0				0.04
Vital signs
SBP (mmHg)	<129				0.14
DBP (mmHg)	<80				0.71
Heart rate (beats/min)	60-100				0.27
Lung function tests
FEV1 (L)	2.5-4.5				0.36
FVC (L)	2.5-4.5				0.86
FEV1/FVC (%)	>75				0.20
Biomarkers
IL-6 (pg/mL)	—				0.36
IL-10 (pg/mL)	—				0.30
PGE2 (pg/mL)	—				0.44
IL1-RA (pg/mL)	—				0.80
TNF-α (pg/mL)	—				0.12
TGF-β (ng/mL)	—				0.80
VEGF (pg/mL)	—				1.00
HGF (pg/mL)	—				0.20

^aThe Mann–Whitney test. ^bData too low to be computed. Significant value at . Abbreviation: WBC: white blood cells; MCV: mean corpuscular volume; HCT: hematocrit; A/G: albumin/globulin; ESR: erythrocyte sedimentation rate; AST: aspartate aminotransferase; ALT: alanine transaminase; HbA1c: hemoglobin A1c; FBS: fasting blood sugar; IGF-1: insulin growth factor-1; DHEAS: dehydropiandrosterone sulphate; SBP: systolic blood pressure; DBP: diastolic blood pressure; FEV1: forced expiratory volume in one second; FVC: forced vital capacity; hs-CRP: high-sensitivity C-reactive protein; IgE: immunoglobulin E; IL-6: interleukin 6; IL-10: interleukin 10; PGE2: prostaglandin E2; IL1-RA: interleukin 1 receptor antagonist; TNF-α: tumor necrosis factor-alpha.