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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02418013
Recruitment Status : Unknown
Verified January 2016 by Myung Ryool Park, Bundang CHA Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 16, 2015
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Myung Ryool Park, Bundang CHA Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Aging Other: Fresh cord blood(experimental group A) Other: Frozen cord blood(experimental group B) Other: Frozen plasma(experimental group C) Other: Placebo group Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fresh cord blood(experimental group A)
16 males and 16 females are assigned to the experimental group A. Dropout is 20 percent in each gender.
 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.
Experimental: Frozen cord blood(experimental group B)
16 males and 16 females are assigned to the experimental group B. Dropout is 20 percent in each gender.
 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
Experimental: Frozen plasma(experimental group C)
16 males and 16 females are assigned to the experimental group C. Dropout is 20 percent in each gender.
 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
Placebo Comparator: Placebo group
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Hand grip strength (in kg) as a measure of efficacy for anti-aging effects [ Time Frame: 6 months period after transplantation ]

    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

  2. SF_36(The Short Form (36) Health Survey) as a measure of improvement in the quality of life [ Time Frame: 6 months period after transplantation ]
    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.

  3. Biomarkers for oxidative stress and inflammation as a measure of efficacy for anti-aging effects [ Time Frame: 6 months period after transplantation ]
    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.

  4. Biomarkers for immune response as a measure of efficacy for anti-aging effects [ Time Frame: 6 months period after transplantation ]

    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


  5. Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects [ Time Frame: Up to 6 months after transplantation ]

    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.


  6. Telomere length as a measure of efficacy for anti-aging effects [ Time Frame: 6 months period after transplantation ]

    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.


  7. Body composition as a measure of efficacy for anti-aging effects [ Time Frame: 6 months period after transplantation ]

    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.


  8. Aging-related genetic and epigenetic markers as a measure of efficacy for anti-aging effects [ Time Frame: 6 months period after transplantation ]

    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.


  9. mitochondria DNA copy number as a measure of efficacy for anti-aging effects [ Time Frame: 6 months period after transplantation ]

    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.


  10. Aging-related growth factors(GDF11, GDF15, Myostatin) as a measure of efficacy for anti-aging effects [ Time Frame: 6 months period after transplantation ]
    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.

  11. DNA damage extent (8-hydroxyguanine level) as a measure of efficacy for anti-aging effects [ Time Frame: 6 months period after transplantation ]

    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.


  12. Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects [ Time Frame: 6 months period after transplantation ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418013


Locations
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Korea, Republic of
Bundang CHA hospital
Seong nam, Bundanggu, Korea, Republic of, 463
Sponsors and Collaborators
Bundang CHA Hospital
Investigators
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Principal Investigator: Myung Ryool Park, PhD orthopedics
More Information
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Responsible Party: Myung Ryool Park, Professor, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT02418013    
Other Study ID Numbers: CHAIRB_BD_V.5.1_F011
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Keywords provided by Myung Ryool Park, Bundang CHA Hospital:
Frailty
Umbilical cord blood
Plasma
 Randomized trial
Double-blinded trial
Placebo-controlled trial
Additional relevant MeSH terms:
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Frailty
Pathologic Processes