Back to resultsClinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma
Primary Purpose
Aging
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fresh cord blood(experimental group A)
Frozen cord blood(experimental group B)
Frozen plasma(experimental group C)
Placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Aging focused on measuring Frailty, Umbilical cord blood, Plasma, Randomized trial, Double-blinded trial, Placebo-controlled trial
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
- Recent and current use of Immunosuppressive drug or HIV patients
- History of hospitalization due to infectious disease such as pneumonia within one year
- Previous (within one months) or current participants in other clinical trials
- Severe kidney (eGFR< 30) and heart failure (Class III/IV)
- Any participants who, in the opinion of the investigators, are considered to have safety problems and/or not to perform tasks successfully
- History of drug or alcohol abuse
- Chronic Hepatitis B or C: history taking
- Known or suspected pregnancy (Women must be subjected to pregnancy test)
- Hypersensitive to dimethyl sulfoxide(DMSO)
Sites / Locations
- Bundang CHA hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Fresh cord blood(experimental group A)
Frozen cord blood(experimental group B)
Frozen plasma(experimental group C)
Placebo group
Arm Description
16 males and 16 females are assigned to the experimental group A. Dropout is 20 percent in each gender.
16 males and 16 females are assigned to the experimental group B. Dropout is 20 percent in each gender.
16 males and 16 females are assigned to the experimental group C. Dropout is 20 percent in each gender.
16 males and 16 females are assigned to the Placebo group. Dropout is 20 percent in each gender. Total participants are 64 in males and 64 in females.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
equal or less than 18 kg for the participants with BMI (body mass index)≤21.89
equal or less than 23 kg for the participants with 22.02 <BMI≤23.63
equal or less than 21.5 kg for the participants with 23.67<BMI≤24.63
equal or less than 25 kg for the participants with BMI>24.88
Female
equal or less than 12.2 kg for the participants with BMI (body mass index)≤22.52
equal or less than 13 kg for the participants with 22.53<BMI ≤24.23
equal or less than 14.5 kg for the participants with 24.24<BMI ≤26.44
equal or less than 13 k
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.
Biomarkers for oxidative stress and inflammation 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. 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.
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
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02418013
Brief Title
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bundang CHA Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging
Keywords
Frailty, Umbilical cord blood, Plasma, Randomized trial, Double-blinded trial, Placebo-controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fresh cord blood(experimental group A)
Arm Type
Experimental
Arm Description
16 males and 16 females are assigned to the experimental group A. Dropout is 20 percent in each gender.
Arm Title
Frozen cord blood(experimental group B)
Arm Type
Experimental
Arm Description
16 males and 16 females are assigned to the experimental group B. Dropout is 20 percent in each gender.
Arm Title
Frozen plasma(experimental group C)
Arm Type
Experimental
Arm Description
16 males and 16 females are assigned to the experimental group C. Dropout is 20 percent in each gender.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
16 males and 16 females are assigned to the Placebo group. Dropout is 20 percent in each gender. Total participants are 64 in males and 64 in females.
Intervention Type
Other
Intervention Name(s)
Fresh cord blood(experimental group A)
Intervention Description
Cord blood is administered through intravenous at CHA clinical trail institute.
Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered prior to the treatment.
Intervention Type
Other
Intervention Name(s)
Frozen cord blood(experimental group B)
Intervention Description
Cord blood is administered through intravenous at CHA clinical trail institute.
Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered
Intervention Type
Other
Intervention Name(s)
Frozen plasma(experimental group C)
Intervention Description
Cord blood is administered through intravenous at CHA clinical trail institute.
Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered
Intervention Type
Other
Intervention Name(s)
Placebo group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
Description
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
Secondary Outcome Measure Information:
Title
Hand grip strength (in kg) as a measure of efficacy for anti-aging effects
Description
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
equal or less than 18 kg for the participants with BMI (body mass index)≤21.89
equal or less than 23 kg for the participants with 22.02 <BMI≤23.63
equal or less than 21.5 kg for the participants with 23.67<BMI≤24.63
equal or less than 25 kg for the participants with BMI>24.88
Female
equal or less than 12.2 kg for the participants with BMI (body mass index)≤22.52
equal or less than 13 kg for the participants with 22.53<BMI ≤24.23
equal or less than 14.5 kg for the participants with 24.24<BMI ≤26.44
equal or less than 13 k
Time Frame
6 months period after transplantation
Title
SF_36(The Short Form (36) Health Survey) as a measure of improvement in the quality of life
Description
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
Title
Biomarkers for oxidative stress and inflammation as a measure of efficacy for anti-aging effects
Description
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
Title
Biomarkers for immune response as a measure of efficacy for anti-aging effects
Description
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
Title
Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects
Description
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
Title
Telomere length as a measure of efficacy for anti-aging effects
Description
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
Title
Body composition as a measure of efficacy for anti-aging effects
Description
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
Title
Aging-related genetic and epigenetic markers as a measure of efficacy for anti-aging effects
Description
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
Title
mitochondria DNA copy number as a measure of efficacy for anti-aging effects
Description
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
Title
Aging-related growth factors(GDF11, GDF15, Myostatin) as a measure of efficacy for anti-aging effects
Description
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
Title
DNA damage extent (8-hydroxyguanine level) as a measure of efficacy for anti-aging effects
Description
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
Title
Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Recent and current use of Immunosuppressive drug or HIV patients
History of hospitalization due to infectious disease such as pneumonia within one year
Previous (within one months) or current participants in other clinical trials
Severe kidney (eGFR< 30) and heart failure (Class III/IV)
Any participants who, in the opinion of the investigators, are considered to have safety problems and/or not to perform tasks successfully
History of drug or alcohol abuse
Chronic Hepatitis B or C: history taking
Known or suspected pregnancy (Women must be subjected to pregnancy test)
Hypersensitive to dimethyl sulfoxide(DMSO)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung Ryool Park, PhD
Organizational Affiliation
orthopedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bundang CHA hospital
City
Seong nam
State/Province
Bundanggu
ZIP/Postal Code
463
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma
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