N/A
N=105
Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT01193660 ↗Enrolled (actual)
105
Serious AEs
18.4%
Results posted
Mar 2012
Primary outcome: Primary: Changes in Motor Performance — 34.5; 38.2; 35.5; 7.00 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Umbilical Cord Blood Infusion (Biological); Erythropoietin Injection (Drug); Active Rehabilitation (Other); Placebo Umbilical Cord Blood (Other); Placebo Erythropoietin (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sung Kwang Medical Foundation
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Motor Performance |
34.5; 38.2; 35.5; 7.00; 4.5; 6.0 | <0.05 sig |
| PRIMARY Changes in Standardized Gross Motor Function |
36.0; 42.6; 36.8; 3.7; 4.3; 4.6 | <0.05 sig |
| SECONDARY Changes in Cognitive Neurodevelopmental Outcome |
94.1; 105.9; 86.6; 8.2; 3.4; 3.3 | <0.05 sig |
| SECONDARY Changes in Motor Neurodevelopmental Outcome |
45.2; 53.3; 45.5; 5.0; 5.2; 2.7 | <0.05 sig |
| SECONDARY Changes in Brain MRI |
0.03; 0.01; 0.01; 0.04; 0.02; 0.02 | — |
| SECONDARY Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism |
1; 0; 0; 1; 0; 0 | 0.05 |
| SECONDARY Changes in Functional Performance in Daily Activities |
39.1; 38.2; 37.4; 42.2; 40.4; 40.0 | — |
| SECONDARY Changes in Functional Independence in Daily Activities |
34.1; 36.6; 31.4; 35.6; 37.5; 33.2 | <0.05 sig |
| SECONDARY Changes in Muscle Strength |
100.7; 104.8; 100.3; 105.0; 106.8; 101.8 | <0.05 sig |
| SECONDARY Changes in Hand Function |
36.0; 52.8; 43.0; 5.0; 5.7; 6.6 | <0.05 sig |
| SECONDARY Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant |
3; 3; 3 | <0.05 sig |
Summary
This randomized control study is aimed to determine efficacy of umbilical cord blood and erythropoietin combination therapy for children with cerebral palsy.
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
Data sourced from ClinicalTrials.gov (NCT01193660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.