KCT0002512
Recruiting
未知
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
Hanyang University Seoul Hospital0 sites98 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hanyang University Seoul Hospital
- Enrollment
- 98
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •¦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
Exclusion Criteria
- •¦ 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
Outcomes
Primary Outcomes
Not specified
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