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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


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 Performance

Changes in Standardized Gross Motor Function

Secondary outcome:

Changes in Cognitive Neurodevelopmental Outcome

Changes 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.


Minimum age: 10 Months. Maximum age: 10 Years. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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