Clinical trial NCT01193660: Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: umbilical cord blood
stem cell
cerebral palsy
Lead sponsor: Sung Kwang Medical Foundation
Sponsor class: OTHER
First posted: 2010-09-02
Enrollment: 105
Sex: ALL
Minimum age (years): 10
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Changes in Motor Performance
timeFrame: Baseline -1 month - 3 months - 6 months
measure: Changes in Standardized Gross Motor Function
timeFrame: Baseline - 1 month - 3 months - 6 months
Secondary outcomes:
measure: Changes in Cognitive Neurodevelopmental Outcome
timeFrame: Baseline -1 month - 3 months - 6 months
measure: Changes in Motor Neurodevelopmental Outcome
timeFrame: Baseline - 1 month - 3 months - 6 months
measure: Changes in Brain MRI
timeFrame: Baseline - 6 months
measure: Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
timeFrame: Baseline - 2 weeks
measure: Changes in Functional Performance in Daily Activities
timeFrame: Baseline -1 month - 3 months - 6 months
measure: Changes in Functional Independence in Daily Activities
timeFrame: Baseline - 1 month - 3 months - 6 months
measure: Changes in Muscle Strength
timeFrame: Baseline - 1 month - 3 months - 6 months
measure: Changes in Hand Function
timeFrame: Baseline - 1 month - 3 months - 6 months
measure: Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: Minyoung Kim, MD, PhD
role: STUDY_CHAIR
References: