Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy
Information source: Sung Kwang Medical Foundation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Palsy
Intervention: Umbilical Cord Blood Infusion (Biological); Erythropoietin Injection (Drug); Active Rehabilitation (Other); Placebo Umbilical Cord Blood (Other); Placebo Erythropoietin (Other)
Phase: N/A
Status: Completed
Sponsored by: Sung Kwang Medical Foundation Official(s) and/or principal investigator(s): Minyoung Kim, MD, PhD, Study Chair, Affiliation: CHA University
Summary
This randomized control study is aimed to determine efficacy of umbilical cord blood and
erythropoietin combination therapy for children with cerebral palsy.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Changes in Motor PerformanceChanges in Standardized Gross Motor Function
Secondary outcome: Changes in Cognitive Neurodevelopmental OutcomeChanges in Motor Neurodevelopmental Outcome Changes in Brain MRI Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism Changes in Functional Performance in Daily Activities Changes in Functional Independence in Daily Activities Changes in Muscle Strength Changes in Hand Function Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant
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.
Eligibility
Minimum age: 10 Months.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, Korea, Republic of
Additional Information
Starting date: May 2010
Last updated: March 1, 2012
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