Aging Clinical Trial
Official title:
A Randomized, Double-blinded and Placebo-controlled Pilot Clinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma by Clinical Markers of Frailty in Adult Who Defined Pre-Frailty
This study aims to carry out a safety evaluation of human cord blood and frozen plasma as
treatment for pre-frailty , to assess whether the treatment can prevent and improve the
aging process, and to identify useful clinical markers of frailty.
The study is a randomized, double-blinded and placebo-controlled pilot clinical Trial
conducted at CHA clinical trial institute.
Assessment criteria for the study include (1) clinical indicators-weight loss, a decrease in
physical activity, weak grip strength, depression; (2) Short Physical Performance
Battery(SPPB); (3) SF-36; (4)cardiac output; (4)biomarkers for oxidative stress,
inflammation and immune response; (5) methylation; (6) mitochondria DNA copy number; (7)
growth factors; (8) antioxidant capacity; (9) hormone assay; (10) genome assay; (11)
metabolite; (12) safety of intravenous administration.
Participants will be randomly assigned to three experimental groups and one control group in
a ratio of 1:1:1:1. At second visit, the participants will be administered with experimental
and placebo agents. Follow-up visits are expected to be at 7 days, 1 and 6 months after the
first treatment. Sixth visit is the completion of it.
Primary end points are defined as severe clinical abnormalities, which could be observed
until 1 month after administration of blood-derived products, including death, pulmonary
embolism, stroke, respiratory stress and hospitalization due to abnormal findings in
laboratory tests.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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