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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

Tracking Information
First Submitted Date  ICMJE March 26, 2015
First Posted Date  ICMJE April 16, 2015
Last Update Posted Date January 13, 2016
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
  • 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
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Aging
Intervention  ICMJE
  • 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.
  • 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
  • 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
  • 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.

Study Arms  ICMJE
  • 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.
    Intervention: Other: Fresh cord blood(experimental group A)
  • 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.
    Intervention: Other: Frozen cord blood(experimental group B)
  • 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.
    Intervention: Other: Frozen plasma(experimental group C)
  • 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.
    Intervention: Other: Placebo group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 13, 2015)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02418013
Other Study ID Numbers  ICMJE CHAIRB_BD_V.5.1_F011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Myung Ryool Park, Bundang CHA Hospital
Study Sponsor  ICMJE Bundang CHA Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Myung Ryool Park, PhD orthopedics
PRS Account Bundang CHA Hospital
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP