Clinical trial NCT02418013: Clinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Aging
Keywords: Frailty
Umbilical cord blood
Plasma
Randomized trial
Double-blinded trial
Placebo-controlled trial
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 64
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of pre-frailty
2. One or two scores in Simple FRAIL questionnaire
3. Aged 55 or over
4. Willing and able to be hospitalized according to the research plan
5. Able to participate in our research during 12 months
6. For women, they must be diagnosed with menopause or infertility

Exclusion Criteria:

1. Diagnosis of being irreversible disabled
2. Dementia or cognitive impairment clinically relevant to it
3. Unable to perform tasks required for analysis of primary end point
4. Scheduled to receive organ transplantation
5. 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
6. Hemoglobin \>17g/dl for male and \>16 g/dl for female
7. Diagnosis of cancer within 5 years or having the possibility to contract cancer
8. Anticancer chemotherapy and radiation therapy
9. History (within 6 months) of acute diseases such as myocardial infarction, unstable angina, stroke, bone fracture
10. Hormone therapy within 6 months
11. Recent and current use of Immunosuppressive drug or HIV patients
12. History of hospitalization due to infectious disease such as pneumonia within one year
13. Previous (within one months) or current participants in other clinical trials
14. Severe kidney (eGFR\< 30) and heart failure (Class III/IV)
15. Any participants who, in the opinion of the investigators, are considered to have safety problems and/or not to perform tasks successfully
16. History of drug or alcohol abuse
17. Chronic Hepatitis B or C: history taking
18. Known or suspected pregnancy (Women must be subjected to pregnancy test)
19. Hypersensitive to dimethyl sulfoxide(DMSO)

Primary outcomes:
measure: Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
timeFrame: 7 days after transplantation
Secondary outcomes:
measure: Hand grip strength (in kg) as a measure of efficacy for anti-aging effects
timeFrame: 6 months period after transplantation
measure: SF_36(The Short Form (36) Health Survey) as a measure of improvement in the quality of life
timeFrame: 6 months period after transplantation
measure: Biomarkers for oxidative stress and inflammation as a measure of efficacy for anti-aging effects
timeFrame: 6 months period after transplantation
measure: Biomarkers for immune response as a measure of efficacy for anti-aging effects
timeFrame: 6 months period after transplantation
measure: Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects
timeFrame: Up to 6 months after transplantation
measure: Telomere length as a measure of efficacy for anti-aging effects
timeFrame: 6 months period after transplantation
measure: Body composition as a measure of efficacy for anti-aging effects
timeFrame: 6 months period after transplantation
measure: Aging-related genetic and epigenetic markers as a measure of efficacy for anti-aging effects
timeFrame: 6 months period after transplantation
measure: mitochondria DNA copy number as a measure of efficacy for anti-aging effects
timeFrame: 6 months period after transplantation
measure: Aging-related growth factors(GDF11, GDF15, Myostatin) as a measure of efficacy for anti-aging effects
timeFrame: 6 months period after transplantation
measure: DNA damage extent (8-hydroxyguanine level) as a measure of efficacy for anti-aging effects
timeFrame: 6 months period after transplantation
measure: Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
timeFrame: 6 months period after transplantation
Other outcomes:
Locations:
city: Seong nam
country: Korea, Republic of
facility: Bundang CHA hospital
state: Bundanggu
Study officials:
affiliation: orthopedics
name: Myung Ryool Park, PhD
role: PRINCIPAL_INVESTIGATOR
References: