Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy
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
2 other identifiers
interventional
105
1 country
1
Brief Summary
This randomized control study is aimed to determine efficacy of umbilical cord blood and erythropoietin combination therapy for children with cerebral palsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 29, 2010
CompletedFirst Posted
Study publicly available on registry
September 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
March 1, 2012
CompletedNovember 24, 2020
November 1, 2020
11 months
August 29, 2010
October 11, 2011
November 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 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.
Baseline -1 month - 3 months - 6 months
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 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.
Baseline - 1 month - 3 months - 6 months
Secondary Outcomes (9)
Changes in Cognitive Neurodevelopmental Outcome
Baseline -1 month - 3 months - 6 months
Changes in Motor Neurodevelopmental Outcome
Baseline - 1 month - 3 months - 6 months
Changes in Brain MRI
Baseline - 6 months
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Baseline - 2 weeks
Changes in Functional Performance in Daily Activities
Baseline -1 month - 3 months - 6 months
- +4 more secondary outcomes
Study Arms (3)
Umbilical Cord Blood & Erythropoietin & Rehabilitation
EXPERIMENTALAllogenic umbilical cord blood infusion, erythropoietin injection \& active rehabilitation
Erythropoietin & Rehabilitation
ACTIVE COMPARATORErythropoietin injection, active rehabilitation
Only Rehabilitation
PLACEBO COMPARATORActive rehabilitation
Interventions
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).
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Known cerebral palsy
- Willing to comply with all study procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Minyoung Kim, MD, PhD
- Organization
- CHA Bundang Medical Center, CHA University
Study Officials
- STUDY CHAIR
Minyoung Kim, MD, PhD
CHA University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2010
First Posted
September 2, 2010
Study Start
May 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
November 24, 2020
Results First Posted
March 1, 2012
Record last verified: 2020-11