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Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy

Sponsor
Sung Kwang Medical Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT01193660
Collaborator
(none)
105
Enrollment
1
Location
3
Arms
11
Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized control study is aimed to determine efficacy of umbilical cord blood and erythropoietin combination therapy for children with cerebral palsy.

Condition or Disease Intervention/Treatment Phase
  • Biological: Umbilical Cord Blood Infusion
  • Drug: Erythropoietin Injection
  • Other: Active Rehabilitation
  • Other: Placebo Umbilical Cord Blood
  • Other: Placebo Erythropoietin
 N/A

Detailed Description

Cerebral palsy is a disorder of movement and posture that result from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability through one's life. Umbilical cord blood(UCB) is suggested as therapeutic method for cerebral palsy which resulted from animal studies. Stem cells included in UCB is expected to exert therapeutic efficacy for functional recovery.

It is also suggested that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed to be neuroprotection and neurogenesis which would reinforce the effect of stem cell as well.

Although autologous umbilical cord would be safe, the children who have problems at birth seldom have autologous umbilical cord blood. Allogenic umbilical cord blood might be useful for these children if its effect is approved.

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Double-blind Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Allogenic Umbilical Cord Blood and Erythropoietin for Children With Cerebral Palsy
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Umbilical Cord Blood & Erythropoietin & Rehabilitation

Allogenic umbilical cord blood infusion, erythropoietin injection & active rehabilitation

Biological: Umbilical Cord Blood Infusion
The subjects will be undertaken allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg) intravenously under non-myeloablative immunosuppression (maintaining blood level of cyclosporine as 100-200ng/mL for 1 month).
Other Names:
  • Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank

    • Drug: Erythropoietin Injection
    Erythropoietin will be given as the schedule of twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times.
    Other Names:
  • Brand name of Erythropoietin: Espogen (made by LG Life Science)

    • Other: Active Rehabilitation
    All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.
    Active Comparator: Erythropoietin & Rehabilitation

    Erythropoietin injection, active rehabilitation

    Drug: Erythropoietin Injection
    Erythropoietin will be given as the schedule of twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times.
    Other Names:
  • Brand name of Erythropoietin: Espogen (made by LG Life Science)

    • Other: Active Rehabilitation
    All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.

    Other: Placebo Umbilical Cord Blood
    Placebo Umbilical Cord Blood will be given except the Experimental arm. Placebo Umbilical Cord Blood was made using peripheral blood. Participants and Investigators maintained as blind.
    Other Names:
  • Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed
  • : 1.5 to 3 ml of the subject's own blood was collected and mixed with 15 to 20 ml of albumin.

    		•
    Placebo Comparator: Only Rehabilitation

    Active rehabilitation

    Other: Active Rehabilitation
    All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.

    Other: Placebo Umbilical Cord Blood
    Placebo Umbilical Cord Blood will be given except the Experimental arm. Placebo Umbilical Cord Blood was made using peripheral blood. Participants and Investigators maintained as blind.
    Other Names:
  • Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed
  • : 1.5 to 3 ml of the subject's own blood was collected and mixed with 15 to 20 ml of albumin.

    • Other: Placebo Erythropoietin
    Placebo Erythropoietin containing Normal Saline

    Outcome Measures

    Primary Outcome Measures

    1. Changes in Motor Performance [Baseline -1 month - 3 months - 6 months]

      GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.

    2. Changes in Standardized Gross Motor Function [Baseline - 1 month - 3 months - 6 months]

      GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.

    Secondary Outcome Measures

    1. Changes in Cognitive Neurodevelopmental Outcome [Baseline -1 month - 3 months - 6 months]

      Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.

    2. Changes in Motor Neurodevelopmental Outcome [Baseline - 1 month - 3 months - 6 months]

      Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.

    3. Changes in Brain MRI [Baseline - 6 months]

      Changes on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter.

    4. Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism [Baseline - 2 weeks]

      18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that "1" refers to INCREASED areas, "-1", DECREASED areas and "0", just NO CHANGE.

    5. Changes in Functional Performance in Daily Activities [Baseline -1 month - 3 months - 6 months]

      Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point.

    6. Changes in Functional Independence in Daily Activities [Baseline - 1 month - 3 months - 6 months]

      WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point.

    7. Changes in Muscle Strength [Baseline - 1 month - 3 months - 6 months]

      Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 ~ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point.

    8. Changes in Hand Function [Baseline - 1 month - 3 months - 6 months]

      QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times.

    9. Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant [6 months]

      The number of patients with serious adverse events within each group; Serious adverse events were defined as any event that resulted in death, was life-threatening, required hospitalization or prolonged the hospital stay, or was otherwise serious in the judgment of the investigator.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Months to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Known cerebral palsy

    • Willing to comply with all study procedure

    Exclusion Criteria:

    • High risk of pneumonia or renal function deterioration after using of immunosuppressant

    • Presence of known genetic disease

    • Possibility of drug hypersensitivity which is related to this study remedy

    • History of previous cell therapy

    • Poor cooperation of guardian,including inactive attitude for rehabilitation

    • Intractable seizure disorder

    • Autism

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHA Bundang Medical Center Seongnam-si Gyeonggi-do Korea, Republic of

    Sponsors and Collaborators

    • Sung Kwang Medical Foundation

    Investigators

    • Study Chair: Minyoung Kim, MD, PhD, CHA University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sung Kwang Medical Foundation
    ClinicalTrials.gov Identifier:
    NCT01193660
    Other Study ID Numbers:
    • RCTUBSC
    • PBC09-095
    First Posted:
    Sep 2, 2010
    Last Update Posted:
    Nov 24, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by Sung Kwang Medical Foundation
    umbilical cord blood
    stem cell
    cerebral palsy
    Additional relevant MeSH terms:
    Paralysis
    Cerebral Palsy
    Epoetin Alfa

    Study Results

    Participant Flow

    Recruitment Details Enrollment Period: May 31, 2010 through April 9, 2011 All participants were recruited at CHA Bundang Medical Center.
    Pre-assignment Detail We tried to recruit 106 subjects. Finally 105 patients were enrolled at the beginning of the overall study and none of the participants were washed out before assignment to groups.
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Period Title: Overall Study
    STARTED 35 36 34
    COMPLETED 31 33 32
    NOT COMPLETED 4 3 2

    Baseline Characteristics

    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation Total
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation Total of all reporting groups
    Overall Participants 35 36 34 105
    Age (Count of Participants)
    <=18 years
    35
    100%
    36
    100%
    34
    100%
    105
    100%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Age (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    45.71
    (18.91)
    50.05
    (24.45)
    46.0
    (19.58)
    47.30
    (21.07)
    Sex: Female, Male (Count of Participants)
    Female
    13
    37.1%
    11
    30.6%
    9
    26.5%
    33
    31.4%
    Male
    22
    62.9%
    25
    69.4%
    25
    73.5%
    72
    68.6%
    Region of Enrollment (participants) [Number]
    Korea, Republic of
    35
    100%
    36
    100%
    34
    100%
    105
    100%

    Outcome Measures

    1. Primary Outcome
    Title Changes in Motor Performance
    Description GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.
    Time Frame Baseline -1 month - 3 months - 6 months

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Measure Participants 31 33 32
    Baseline
    34.5
    (2.7)
    38.2
    (2.8)
    35.5
    (2.9)
    1 month - Baseline
    7.00
    (1.3)
    4.5
    (0.6)
    6.0
    (1.0)
    3 months - Baseline
    11.5
    (1.5)
    7.5
    (0.8)
    8.1
    (1.2)
    6 months - Baseline
    14.5
    (1.8)
    9.2
    (0.8)
    9.6
    (1.2)
    3 months - 1 month
    4.5
    (0.7)
    2.9
    (0.5)
    2.1
    (0.6)
    6 months - 1 month
    7.5
    (0.9)
    4.7
    (0.7)
    3.6
    (0.7)
    6 months - 3 months
    3.1
    (0.6)
    1.7
    (0.5)
    1.5
    (0.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Umbilical Cord Blood & Erythropoietin & Rehabilitation, Erythropoietin & Rehabilitation, Only Rehabilitation
    Comments In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Repeated Measure ANOVA
    Comments
    Method of Estimation Estimation Parameter Wilks' Lambda (group*visit effect)
    Estimated Value 2.59
    Confidence Interval () 95%
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Changes in Cognitive Neurodevelopmental Outcome
    Description Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.
    Time Frame Baseline -1 month - 3 months - 6 months

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Measure Participants 31 33 32
    BSID-II Mental Scale: Baseline
    94.1
    (9.1)
    105.9
    (8.9)
    86.6
    (9.0)
    BSID-II Mental Scale: 1 month - Baseline
    8.2
    (1.3)
    3.4
    (0.5)
    3.3
    (0.6)
    BSID-II Mental Scale: 3 months - Baseline
    12.0
    (1.4)
    7.4
    (0.9)
    5.8
    (0.8)
    BSID-II Mental Scale: 6 months - Baseline
    17.6
    (1.8)
    11.5
    (1.3)
    9.9
    (1.6)
    BSID-II Mental Scale: 3 months - 1 month
    3.8
    (0.8)
    4.0
    (0.7)
    2.5
    (0.7)
    BSID-II Mental Scale: 6 months - 1 month
    9.4
    (1.4)
    8.1
    (1.3)
    6.6
    (1.4)
    BSID-II Mental Scale: 6 months - 3 months
    5.6
    (1.2)
    4.1
    (0.8)
    4.1
    (1.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Umbilical Cord Blood & Erythropoietin & Rehabilitation, Erythropoietin & Rehabilitation, Only Rehabilitation
    Comments The null hypothesis is that in terms of K-BSID-II MENTAL Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Repeated Measure ANOVA
    Comments
    Method of Estimation Estimation Parameter Wilks' Lambda (group*visit effect)
    Estimated Value 3.94
    Confidence Interval () 95%
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Changes in Motor Neurodevelopmental Outcome
    Description Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.
    Time Frame Baseline - 1 month - 3 months - 6 months

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Measure Participants 31 33 32
    BSID-II Motor Scale: Baseline
    45.2
    (4.7)
    53.3
    (5.0)
    45.5
    (4.6)
    BSID-II Motor Scale: 1 month - Baseline
    5.0
    (1.5)
    5.2
    (2.1)
    2.7
    (0.6)
    BSID-II Motor Scale: 3 months - Baseline
    9.5
    (1.9)
    6.8
    (2.1)
    4.3
    (0.8)
    BSID-II Motor Scale: 6 months - Baseline
    11.7
    (2.0)
    7.6
    (2.2)
    5.2
    (0.9)
    BSID-II Motor Scale: 3 months - 1 month
    4.5
    (1.0)
    1.6
    (0.5)
    1.5
    (0.4)
    BSID-II Motor Scale: 6 months - 1 month
    6.7
    (1.3)
    2.5
    (0.6)
    2.5
    (0.5)
    BSID-II Motor Scale: 6 months - 3 months
    2.2
    (0.6)
    0.9
    (0.4)
    1.0
    (0.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Umbilical Cord Blood & Erythropoietin & Rehabilitation, Erythropoietin & Rehabilitation, Only Rehabilitation
    Comments The null hypothesis is that in terms of K-BSID-II MOTOR Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Repeated Measure ANOVA
    Comments
    Method of Estimation Estimation Parameter Wilks' Lambda (group*visit effect)
    Estimated Value 2.70
    Confidence Interval () 95%
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Changes in Brain MRI
    Description Changes on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter.
    Time Frame Baseline - 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Measure Participants 30 31 29
    Anterior portion of Rt. posterior Internal Capsule
    0.03
    (0.01)
    0.01
    (0.01)
    0.01
    (0.01)
    Posterior portion of Rt posterior Internal Capsule
    0.04
    (0.01)
    0.02
    (0.01)
    0.02
    (0.02)
    Anterior portion of Lt. posterior Internal Capsule
    0.03
    (0.01)
    0.02
    (0.01)
    0.04
    (0.02)
    Posterior portion of Lt posterior Internal Capsule
    0.05
    (0.02)
    0.04
    (0.02)
    0.05
    (0.02)
    5. Secondary Outcome
    Title Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
    Description 18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that "1" refers to INCREASED areas, "-1", DECREASED areas and "0", just NO CHANGE.
    Time Frame Baseline - 2 weeks

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Measure Participants 31 33 32
    Rt. Lentiform Nucleus, Gray Matter, Putamen
    1
    0
    0
    Lt. Frontal Lobe, Medial Frontal Gyrus
    1
    0
    0
    Lt. Sub-lobar, Insula
    1
    0
    -1
    Lt. Lentiform Nucleus, Gray Matter, Putamen
    1
    0
    0
    Lt.Lentiform Nucleus, Gray Matter, Globus Pallidus
    1
    0
    0
    Lt. Midbrain (Thalamus)
    1
    0
    0
    Rt. Parietal Lobe, Precuneus
    1
    0
    0
    Lt. Temporal Lobe, Middle Temporal Gyrus
    1
    0
    -1
    Rt. Parietal Lobe, Pre- and Post-central Gyrus
    1
    0
    0
    Rt. Frontal Lobe, Paracentral Lobule
    0
    1
    0
    Rt. Limbic Lobe, Anterior Cingulate
    0
    1
    0
    Lt. Frontal Lobe, Precentral Gyrus
    0
    1
    0
    Lt. Lentiform Nucleus, Putamen
    0
    1
    0
    Rt. Cerebellar Anterior Lobe, Culmen
    0
    1
    1
    Lt. Cerebellar Posterior Lobe, Cerebellar Tonsil
    0
    1
    1
    Rt. Frontal Lobe, Orbital Gyrus
    0
    1
    1
    Rt. Occipital Lobe, Middle Occipital Gyrus
    -1
    0
    0
    Lt. Limbic Lobe, Parahippocampal Gyrus
    -1
    0
    0
    Rt. Limbic Lobe, Parahippocampal Gyrus
    -1
    0
    -1
    Rt Cerebellum, Posterior Lobe, Declive
    0
    -1
    0
    Rt Cerebellum, Anterior Lobe, Culmen, Occipital
    0
    -1
    0
    Lt Cerebellum, Posterior Lobe, Declive, Occipital
    0
    -1
    0
    Lt. Frontal Lobe, Middle Frontal Gyrus
    0
    0
    -1
    Rt. Frontal Lobe, Middle Frontal Gyrus
    0
    0
    -1
    Rt. Frontal Lobe, Sub-gyral
    0
    0
    -1
    Lt. Temporal Lobe, Fusiform Gyrus
    0
    0
    -1
    Lt. Temporal Lobe, Inferior Temporal Gyrus
    0
    0
    -1
    Rt. Temporal Lobe, Middle Temporal Gyrus
    0
    0
    -1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Umbilical Cord Blood & Erythropoietin & Rehabilitation, Erythropoietin & Rehabilitation, Only Rehabilitation
    Comments In our analysis, the null hypothesis is that the effects of three experimental groups are same each other, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) has much higher than that of either Erythropoietin + Rehabilitation Group or Rehabilitation Group. This study is a pilot study and therefore, power calculation was not applicable in our study. The sample size of each group is more than 30.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.05
    Comments The baseline and post-therapy data of each group were compared using paired t-test statistics.
    Method t-test, 2 sided
    Comments Voxels with an uncorrected p-value of <0.05 were considered significant, and an extent threshold Ke of 100 voxels was set by SPM implanted in Matlab.
    6. Secondary Outcome
    Title Changes in Functional Performance in Daily Activities
    Description Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point.
    Time Frame Baseline -1 month - 3 months - 6 months

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Measure Participants 31 33 32
    Self care of FSS: Baseline
    39.1
    (2.5)
    38.2
    (2.7)
    37.4
    (2.2)
    Self care of FSS: 1 month
    42.2
    (2.2)
    40.4
    (2.9)
    40.0
    (2.2)
    Self care of FSS: 3 months
    44.7
    (2.4)
    43.5
    (2.9)
    41.7
    (2.3)
    Self care of FSS: 6 months
    46.5
    (2.5)
    45.0
    (2.8)
    42.8
    (2.3)
    Mobility of FSS: Baseline
    24.8
    (3.7)
    29.2
    (4.3)
    24.9
    (3.7)
    Mobility of FSS: 1 month
    28.1
    (3.9)
    32.4
    (4.3)
    27.9
    (3.8)
    Mobility of FSS: 3 months
    31.7
    (4.3)
    34.6
    (4.3)
    29.3
    (3.9)
    Mobility of FSS: 6 months
    34.6
    (4.3)
    36.6
    (4.4)
    31.4
    (3.9)
    Social function of FSS: Baseline
    40.0
    (3.5)
    40.1
    (3.3)
    34.8
    (3.5)
    Social function of FSS: 1 month
    42.8
    (3.6)
    42.5
    (3.3)
    37.5
    (3.6)
    Social function of FSS: 3 months
    46.4
    (3.9)
    45.8
    (3.3)
    40.0
    (3.5)
    Social function of FSS: 6 months
    49.1
    (3.6)
    47.8
    (3.4)
    42.3
    (3.9)
    Self care of CAS: Baseline
    18.0
    (4.1)
    17.9
    (3.7)
    15.3
    (3.2)
    Self care of CAS: 1 month
    20.1
    (4.0)
    21.1
    (3.8)
    19.0
    (3.7)
    Self care of CAS: 3 months
    27.0
    (4.3)
    24.2
    (3.9)
    21.5
    (3.7)
    Self care of CAS: 6 months
    29.4
    (4.0)
    26.0
    (4.1)
    23.1
    (3.9)
    Mobility of CAS: Baseline
    14.6
    (4.1)
    19.7
    (4.8)
    13.5
    (4.0)
    Mobility of CAS: 1 month
    19.6
    (4.5)
    22.6
    (4.9)
    15.6
    (4.2)
    Moblity of CAS: 3 months
    22.5
    (5.1)
    26.0
    (5.3)
    19.3
    (4.5)
    Mobility of CAS: 6 months
    24.9
    (5.5)
    29.2
    (5.4)
    24.0
    (4.8)
    Social function of CAS: Baseline
    23.0
    (5.2)
    24.7
    (3.9)
    18.2
    (4.4)
    Social function of CAS: 1 month
    28.5
    (5.6)
    30.0
    (4.5)
    21.1
    (4.8)
    Social function of CAS: 3 months
    34.8
    (6.0)
    34.2
    (4.8)
    24.2
    (5.0)
    Social function of CAS: 6 months
    38.4
    (6.2)
    36.2
    (4.6)
    27.6
    (5.3)
    7. Primary Outcome
    Title Changes in Standardized Gross Motor Function
    Description GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.
    Time Frame Baseline - 1 month - 3 months - 6 months

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Measure Participants 31 33 32
    Baseline
    36.0
    (4.7)
    42.6
    (4.9)
    36.8
    (4.5)
    1 month - Baseline
    3.7
    (0.4)
    4.3
    (0.5)
    4.6
    (0.6)
    3 months - Baseline
    6.5
    (0.9)
    6.8
    (0.8)
    6.4
    (0.7)
    6 months - Baseline
    9.1
    (1.2)
    9.0
    (1.1)
    7.8
    (0.9)
    3 months - 1 month
    2.9
    (0.8)
    2.5
    (0.5)
    1.8
    (0.4)
    6 months - 1 month
    5.4
    (1.2)
    4.7
    (0.9)
    3.1
    (0.6)
    6 months - 3 months
    2.6
    (0.5)
    2.2
    (0.6)
    1.3
    (0.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Umbilical Cord Blood & Erythropoietin & Rehabilitation, Erythropoietin & Rehabilitation, Only Rehabilitation
    Comments In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Repeated Measure ANOVA
    Comments
    Method of Estimation Estimation Parameter interaction of group and visit
    Estimated Value 0.90
    Confidence Interval () 95%
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Changes in Functional Independence in Daily Activities
    Description WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point.
    Time Frame Baseline - 1 month - 3 months - 6 months

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Measure Participants 31 33 32
    Baseline
    34.1
    (3.8)
    36.6
    (3.7)
    31.4
    (2.9)
    1 month
    35.6
    (4.1)
    37.5
    (3.8)
    33.2
    (3.1)
    3 months
    38.7
    (4.7)
    38.5
    (4.1)
    37.1
    (3.8)
    6 months
    41.1
    (4.8)
    40.3
    (4.2)
    37.7
    (4.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Umbilical Cord Blood & Erythropoietin & Rehabilitation, Erythropoietin & Rehabilitation, Only Rehabilitation
    Comments In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Repeated Measure ANOVA
    Comments
    Method of Estimation Estimation Parameter Wilks' Lambda (group*visit effect)
    Estimated Value 1.279
    Confidence Interval () 95%
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Changes in Muscle Strength
    Description Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 ~ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point.
    Time Frame Baseline - 1 month - 3 months - 6 months

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Measure Participants 31 33 32
    Baseline
    100.7
    (5.5)
    104.8
    (4.4)
    100.3
    (4.6)
    1 month
    105.0
    (4.9)
    106.8
    (4.5)
    101.8
    (4.6)
    3 months
    107.8
    (4.4)
    107.7
    (4.5)
    103.6
    (4.6)
    6 months
    109.9
    (4.6)
    109.3
    (4.5)
    104.3
    (4.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Umbilical Cord Blood & Erythropoietin & Rehabilitation, Erythropoietin & Rehabilitation, Only Rehabilitation
    Comments In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Repeated Measure ANOVA
    Comments
    Method of Estimation Estimation Parameter Wilks' Lambda (group*visit effect)
    Estimated Value 0.996
    Confidence Interval () 95%
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Changes in Hand Function
    Description QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times.
    Time Frame Baseline - 1 month - 3 months - 6 months

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Measure Participants 31 33 32
    Baseline
    36.0
    (6.4)
    52.8
    (4.9)
    43.0
    (5.5)
    1 month - Baseline
    5.0
    (1.4)
    5.7
    (1.7)
    6.6
    (1.4)
    3 months - Baseline
    11.1
    (2.2)
    8.8
    (2.0)
    10.5
    (1.8)
    6 months - Baseline
    13.9
    (2.6)
    10.7
    (2.2)
    13.0
    (2.4)
    3 months - 1 month
    5.7
    (1.6)
    3.1
    (1.0)
    3.5
    (1.7)
    6 months - 1 month
    8.4
    (2.0)
    5.1
    (1.3)
    6.4
    (2.1)
    6 months - 3 months
    2.8
    (0.8)
    2.4
    (0.8)
    3.1
    (1.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Umbilical Cord Blood & Erythropoietin & Rehabilitation, Erythropoietin & Rehabilitation, Only Rehabilitation
    Comments In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Repeated Measure ANOVA
    Comments
    Method of Estimation Estimation Parameter Wilks' Lambda (group*visit effect)
    Estimated Value 0.56
    Confidence Interval () 95%
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant
    Description The number of patients with serious adverse events within each group; Serious adverse events were defined as any event that resulted in death, was life-threatening, required hospitalization or prolonged the hospital stay, or was otherwise serious in the judgment of the investigator.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    Measure Participants 31 33 32
    Number [participants]
    3
    8.6%
    3
    8.3%
    3
    8.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Umbilical Cord Blood & Erythropoietin & Rehabilitation, Erythropoietin & Rehabilitation, Only Rehabilitation
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Fisher Exact
    Comments We compared the ratio of participants with a certain adverse event (AE) and without the AE between three groups using Fisher Exact test.

    Adverse Events

    Time Frame Baseline - 1 month - 3 months - 6 months
    Adverse Event Reporting Description
    Arm/Group Title Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Arm/Group Description Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation Active rehabilitation
    All Cause Mortality
    Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/35 (8.6%) 3/6 (50%) 3/8 (37.5%)
    Nervous system disorders
    Seizure 0/35 (0%) 0 1/6 (16.7%) 1 0/8 (0%) 0
    Renal and urinary disorders
    Urinary tract infection 0/35 (0%) 0 0/6 (0%) 0 1/8 (12.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Pneumonia 1/35 (2.9%) 1 2/6 (33.3%) 3 1/8 (12.5%) 1
    Influenza 1/35 (2.9%) 1 0/6 (0%) 0 1/8 (12.5%) 1
    Death 1/35 (2.9%) 1 0/6 (0%) 0 0/8 (0%) 0
    Other (Not Including Serious) Adverse Events
    Umbilical Cord Blood & Erythropoietin & Rehabilitation Erythropoietin & Rehabilitation Only Rehabilitation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 30/35 (85.7%) 29/36 (80.6%) 32/34 (94.1%)
    Blood and lymphatic system disorders
    Anemia 1/35 (2.9%) 1 0/0 (NaN) 0 0/18 (0%) 0
    Ear and labyrinth disorders
    Otitis media acute 1/35 (2.9%) 1 1/14 (7.1%) 1 0/18 (0%) 0
    Eye disorders
    Conjunctival irritations 0/35 (0%) 0 1/14 (7.1%) 1 1/18 (5.6%) 2
    Gastrointestinal disorders
    Constipation 5/35 (14.3%) 5 4/14 (28.6%) 4 5/18 (27.8%) 5
    Dyspepsia 5/35 (14.3%) 5 2/36 (5.6%) 2 2/18 (11.1%) 2
    Nausea, vomiting 6/35 (17.1%) 6 5/36 (13.9%) 5 2/18 (11.1%) 2
    Diarrhea 6/35 (17.1%) 6 2/36 (5.6%) 2 2/18 (11.1%) 2
    Colitis 0/35 (0%) 0 1/14 (7.1%) 1 2/18 (11.1%) 2
    Anorexia 5/35 (14.3%) 5 2/36 (5.6%) 2 1/18 (5.6%) 1
    Infections and infestations
    Herpangina 0/35 (0%) 0 2/14 (14.3%) 2 1/18 (5.6%) 1
    Fever 12/35 (34.3%) 12 4/36 (11.1%) 4 8/18 (44.4%) 8
    Nervous system disorders
    Seizure 1/35 (2.9%) 1 3/36 (8.3%) 6 3/18 (16.7%) 7
    Febrile convulsioin 2/35 (5.7%) 3 1/14 (7.1%) 1 0/18 (0%) 0
    Psychiatric disorders
    Irritability 4/35 (11.4%) 4 0/14 (0%) 0 0/18 (0%) 0
    Insomnia 0/35 (0%) 0 1/36 (2.8%) 1 1/18 (5.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Bronchitis 4/35 (11.4%) 4 4/14 (28.6%) 4 3/18 (16.7%) 3
    Pneumonia 6/35 (17.1%) 6 0/14 (0%) 0 0/18 (0%) 0
    Upper respiratory tract infection 18/35 (51.4%) 20 19/36 (52.8%) 23 21/34 (61.8%) 24
    Hypoxia 3/35 (8.6%) 3 1/36 (2.8%) 1 1/18 (5.6%) 1
    Skin and subcutaneous tissue disorders
    Dermatitis 0/35 (0%) 0 2/36 (5.6%) 2 2/18 (11.1%) 2
    Urticaria 2/35 (5.7%) 2 1/14 (7.1%) 1 4/18 (22.2%) 4
    Hirsuitism 2/35 (5.7%) 2 0/0 (NaN) 0 0/0 (NaN) 0
    Alopecia 1/35 (2.9%) 1 0/0 (NaN) 0 0/0 (NaN) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Minyoung Kim, MD, PhD
    Organization CHA Bundang Medical Center, CHA University
    Phone 82-31-780-1872
    Email kmin@cha.ac.kr
    Responsible Party:
    Sung Kwang Medical Foundation
    ClinicalTrials.gov Identifier:
    NCT01193660
    Other Study ID Numbers:
    • RCTUBSC
    • PBC09-095
    First Posted:
    Sep 2, 2010
    Last Update Posted:
    Nov 24, 2020
    Last Verified:
    Nov 1, 2020