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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
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.
1. Cord blood is administered through intravenous at CHA clinical trail institute. 2. Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered
1. Cord blood is administered through intravenous at CHA clinical trail institute. 2. Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered
Bundang CHA hospital
Seongnam, Bundanggu, South Korea
Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
The investigators will assess changes in scores from baseline at 7 days after transplantation. After normality test, either unpaired t-test or wilcoxon rank sum test will be conducted.
Time frame: 7 days after transplantation
Hand grip strength (in kg) as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation and at 1 week , 1 month, 6 months after the treatments. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis. The followings are diagnosis criteria for frailty based on hand grip strength(in kg): Male 1. equal or less than 18 kg for the participants with BMI (body mass index)≤21.89 2. equal or less than 23 kg for the participants with 22.02 \<BMI≤23.63 3. equal or less than 21.5 kg for the participants with 23.67\<BMI≤24.63 4. equal or less than 25 kg for the participants with BMI\>24.88 Female 1. equal or less than 12.2 kg for the participants with BMI (body mass index)≤22.52 2. equal or less than 13 kg for the participants with 22.53\<BMI ≤24.23 3. equal or less than 14.5 kg for the participants with 24.24\<BMI ≤26.44 4. equal or less than 13 k
Time frame: 6 months period after transplantation
SF_36(The Short Form (36) Health Survey) as a measure of improvement in the quality of life
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes compared to baseline which will be measured at the day of transplantation. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Time frame: 6 months period after transplantation
Biomarkers for oxidative stress and inflammation as a measure of efficacy for anti-aging effects
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. Changes in biomarkers such as CRP, IL-1,6, IL-10, LIF, D-dimer, fibrinogen, TNF-α, CBC with differential, malondialdehyde, 4-hydroxynonenal will be assessed. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Time frame: 6 months period after transplantation
Biomarkers for immune response as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes of the immune-related biomarkers compared to baseline which will be measured at the day of transplantation. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis. Followings are immune markers to be tested -Eotaxin, FGF-2,Flt-3 Ligand ,Fractalkine,G-CSF, GM-CSF, GRO, IFNa2, IFNr, IL-1a, IL-1b, IL-1ra, IL-2, IL-3, IL-4 ,IL-5 ,IL-6 ,IL-7, IL-8, IL-9, IL-10, IL-12(p40), IL-12(p70), IL-13, IL-15, IL-17, IP-10, MCP-1, MCP-3, MDC, MIP-1a, MIP-1b, PDGF-AA, PDGF-AB/BB, RANTES, sCD40L, sIL-2Ra TGFa, TNFa,TNFb, VEGF
Time frame: 6 months period after transplantation
Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes in hormone levels compared to baseline which will be measured at the day of transplantation. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Time frame: Up to 6 months after transplantation
Telomere length as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. Whether the treatments protect telomere from shortening will be investigated through the comparison analysis. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Time frame: 6 months period after transplantation
Body composition as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes of body composition compared to baseline which will be measured at the day of transplantation. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Time frame: 6 months period after transplantation
Aging-related genetic and epigenetic markers as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes of aging-related genetic markes (e.g ELOVL2. ) compared to baseline which will be measured at the day of transplantation. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Time frame: 6 months period after transplantation
mitochondria DNA copy number as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. Mitochondria DNA copy number of participants will be compared among the treatment groups. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Time frame: 6 months period after transplantation
Aging-related growth factors(GDF11, GDF15, Myostatin) as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes compared to baseline which will be measured at the day of transplantation. The factors will be compared among the treatment groups. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Time frame: 6 months period after transplantation
DNA damage extent (8-hydroxyguanine level) as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes of 8-hydroxyguanine in white blood compared to baseline which will be measured at the day of transplantation. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Time frame: 6 months period after transplantation
Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
The test is scheduled to be conducted at the day of transplantation (2nd visit) and at 1 week (3rd visit), 1 month (4th visit), 6 months (5th visit) after the treatments. The investigators will assess changes in scores compared to baseline which will be measured at the day of transplantation. After normality test on the average difference, either unpaired t-test or wilcoxon rank sum test will be conducted for statistical analysis.
Time frame: 6 months period after transplantation