NCT02418013

Clinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Bundang CHA Hospital · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Aging

Interventions

Type	Name	Description
OTHER	Fresh cord blood(experimental group A)	1. Cord blood is administered through intravenous at CHA clinical trail institute. 2. Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered prior to the treatment.
OTHER	Frozen cord blood(experimental group B)	1. Cord blood is administered through intravenous at CHA clinical trail institute. 2. Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered
OTHER	Frozen plasma(experimental group C)	1. Cord blood is administered through intravenous at CHA clinical trail institute. 2. Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered
OTHER	Placebo group	A placebo agent is administered through intravenous at CHA clinical trail institute. It should be certain that when administered, participants are not aware of which treatments are preformed.

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2015-04-16
• Last updated: 2016-01-13

Locations

1 site across 1 country: South Korea