Clinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma
NCT ID: NCT02418013
Last Updated: 2016-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
64 participants
INTERVENTIONAL
2015-03-31
2017-08-31
Brief Summary
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The study is a randomized, double-blinded and placebo-controlled pilot clinical Trial conducted at CHA clinical trial institute.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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
Frozen plasma(experimental group C)
16 males and 16 females are assigned to the experimental group C. Dropout is 20 percent in each gender.
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 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.
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.
Interventions
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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.
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
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 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.
Eligibility Criteria
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Inclusion Criteria
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
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)
55 Years
ALL
No
Sponsors
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Bundang CHA Hospital
OTHER
Responsible Party
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Myung Ryool Park
Professor
Principal Investigators
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Myung Ryool Park, PhD
Role: PRINCIPAL_INVESTIGATOR
orthopedics
Locations
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Bundang CHA hospital
Seongnam, Bundanggu, South Korea
Countries
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Other Identifiers
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CHAIRB_BD_V.5.1_F011
Identifier Type: -
Identifier Source: org_study_id
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