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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Aging
- Sponsor
- Bundang CHA Hospital
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Myung Ryool Park
Professor
Bundang CHA Hospital
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of pre-frailty
- •One or two scores in Simple FRAIL questionnaire
- •Aged 55 or over
- •Willing and able to be hospitalized according to the research plan
- •Able to participate in our research during 12 months
- •For women, they must be diagnosed with menopause or infertility
Exclusion Criteria
- •Diagnosis of being irreversible disabled
- •Dementia or cognitive impairment clinically relevant to it
- •Unable to perform tasks required for analysis of primary end point
- •Scheduled to receive organ transplantation
- •Hemoglobin \< 8 g/dl; white blood cells count \<3000/mm3; absolute Neutrophil count \< 500/dl; Thrombocyte count \<80,000/mm3; , AST/ALT or ALP \> 3 times the normal level
- •Hemoglobin \>17g/dl for male and \>16 g/dl for female
- •Diagnosis of cancer within 5 years or having the possibility to contract cancer
- •Anticancer chemotherapy and radiation therapy
- •History (within 6 months) of acute diseases such as myocardial infarction, unstable angina, stroke, bone fracture
- •Hormone therapy within 6 months
Outcomes
Primary Outcomes
Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
Time Frame: 7 days after transplantation
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.
Secondary Outcomes
- Biomarkers for oxidative stress and inflammation as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects(Up to 6 months after transplantation)
- Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Hand grip strength (in kg) as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Telomere length as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Body composition as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- DNA damage extent (8-hydroxyguanine level) as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- SF_36(The Short Form (36) Health Survey) as a measure of improvement in the quality of life(6 months period after transplantation)
- Biomarkers for immune response as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Aging-related genetic and epigenetic markers as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- mitochondria DNA copy number as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Aging-related growth factors(GDF11, GDF15, Myostatin) as a measure of efficacy for anti-aging effects(6 months period after transplantation)