Phase II, randomized, double-blind clinical trial for efficacy of Granulocyte-colony stimulating factor(G-CSF) and autologous cord blood infusion in children with cerebral palsy
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0002512
- Lead Sponsor
- Hanyang University Seoul Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 98
¦A patient who was diagnosed with a mild case, and severity case of cerebral palsy or developmental disability through developmental assessment from more than two specialists including a specialist in pediatrics and rehabilitation medicine
¦Aged 2~10(in full)
¦In case there is a sign of the general decrease in white matter, or periventricular leukomalacia near cerebral ventricles in MRI-DTI(photographed before a clinical trial)test
¦A subject who did a written consent to participation in this clinical trial through the very person and a legal representative-a guardian
¦ In case a patient underwent a surgical procedure, or was administered medicated medicine which are known to have neuroprotective effects even partially, such as autologous cord blood and erythropoietin, and Granulocyte-colony stimulating factor(G-CSF), etc. within one year before participating in a clinical trial
¦ Accompanied by a serious disease, such as chromosome abnormality, etc.
¦ In case where a patient’s medical condition is judged to be maladapted by a researcher
¦ In case a patient or his/her legal representative doesn’t agree to participation in a clinical trial
¦ A patient having a medical history of hypersensitivity to Granulocyte-colony stimulating factor(G-CSF)
¦ A patient having a predisposition to allergies
¦ A patient having serious disorders in the liver, kidney, and cardiopulmonary function
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Confirm the safety of autologous cord blood infusion and repeated injection of Granulocyte colony-stimulating factorin children with cerebral palsy by repeated follow-up every 3 months over 18 months with clinical and laboratory evaluations
- Secondary Outcome Measures
Name Time Method Confirm the efficacy of autologous cord blood infusion and/or Granulocyte colony-stimulating factor in children with cerebral palsy using standardized Gross Motor Function Measure evaluation.