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Cerebral PalsyPhase 2NCT01528436

Umbilical Cord Blood Therapy for Cerebral Palsy

A Phase 2 study testing Umbilical Cord Blood Infusion and Active Rehabilitation in people with Cerebral Palsy, run by MinYoung Kim, M.D. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy. Read more about this study

Who is it for?
Ages 6 months to 20 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Umbilical Cord Blood Infusion and Active Rehabilitation
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
1 siteSouth Korea
Study dates
Feb 2012to Jul 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Cerebral Palsy with abnormal muscle tone
  • Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
  • Willing to comply with all study procedure

Who cannot join

  • Medical instability including pneumonia or renal function at enrollment
  • Presence of known genetic disease
  • Presence of drug hypersensitivity which is related to this study remedy
  • Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
  • Decision by the principal investigator when there are unexpected events including brain surgery, that may affect the outcome

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 463-712

Other trials in South Korea

About this study

Official title: Umbilical Cord Blood Therapy for Cerebral Palsy: a Randomized,Double-blind, Placebo-controlled Trial

This randomized controlled study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.

Read the detailed description

Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.

On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

Conditions
Cerebral Palsy
Being tested
Umbilical Cord Blood Infusion, Placebo Umbilical Cord Blood, Active Rehabilitation
Keywords
Cerebral Palsy, Umbilical Cord Blood, Rehabilitation
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Umbilical Cord Blood InfusionBiological

    Also called Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank

    The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.

  • Placebo Umbilical Cord BloodOther

    Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed.

  • Active RehabilitationOther

    All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.

Study groups in NCT01528436
Study groupRoleWhat they receive
Umbilical Cord Blood and RehabilitationExperimentalAllogeneic Umbilical Cord Blood infusion and Active Rehabilitation
Receives: Biological: Umbilical Cord Blood Infusion; Other: Active Rehabilitation
Placebo Umbilical Cord Blood and RehabilitationActive comparatorPlacebo Umbilical Cord Blood infusion and Active Rehabilitation
Receives: Other: Placebo Umbilical Cord Blood; Other: Active Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Motor Performance

    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 will report GMPM scores at each assessment time points.

    Measured: Baseline - 1 month - 3 months

  2. Changes in Standardized Gross Motor Function

    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 will report GMFM scores at each assessment time points.

    Measured: Baseline - 1 month - 3 months

Secondary outcomes (7)

  1. Changes in Cognitive Neurodevelopmental Outcome

    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 will report K-BSID-II Mental Scale raw scores at each assessment time points.

    Measured: Baseline - 1 month - 3 months

  2. Changes in Motor Neurodevelopmental Outcome

    Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 112 - best). We will report K-BSID-II Motor Scale raw scores at each assessment time points.

    Measured: Baseline - 1 month - 3 months

  3. Changes in Functional Independence in Daily Activities

    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. We will report total WeeFIM scores measured at each assessment time points.

    Measured: Baseline - 1 month - 3 months

  4. Changes in Visual Perception Test

    We will evaluate visual perception function with one of three measures: DTVP (Developmental Test of Visual Perception), MVPT (Motor-free Visual Perception Test), and VMI (Visual-Motor Integration, Visual Perception and Motor Coordination). All can be scored as percentile rank from 0 to 100. Higher values mean better visual perception ability.

    Measured: Baseline - 1 month - 3 months

  5. Changes in Muscle Strength

    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 scores mean better muscle strength. Categories of outcome table will be summation of MMT scores measured at each assessment time point.

    Measured: Baseline - 1 month - 3 months

  6. Changes in Functional Performance in Daily Activities

    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 will report 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 will be each domain scores measured at each assessment time point.

    Measured: Baseline - 1 month - 3 months

  7. Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET

    18F-FDG PET imaging will be underwent twice prior to and then 2 weeks post-treatment. All scans will be reviewed by a nuclear physician. Spatial pre-processing and statistical analyses will be done 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 will reported increased areas and decreased areas of glucose metabolism in two groups.

    Measured: Baseline - 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01528436
Sponsor's protocol ID
CPUCBRCT
Status last verified
Jul 2012
First submitted
3 Feb 2012
Last updated
18 Jul 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Umbilical Cord Blood Infusion and Active Rehabilitation in people with Cerebral Palsy, run by MinYoung Kim, M.D. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Motor Performance (time frame: Baseline - 1 month - 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528436.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.

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