To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.
This is a Phase 1 clinical trial that constitutes two time points cohorts with participants who will receive intravenous autologous umbilical cord blood and 0.9% sodium chloride respectively. The timing of treatment is any time after the diagnosis of cerebral palsy. The investigator will proceed the groups during the same period. 1. Demographic Data and Baseline Characteristics of the Studied Group were collected: * Basic patient's information survey * Medical history * Physical examination * Basic blood test result * Children's developmental disorders evaluation before the treatment * Brain Magnetic Resonance Imaging-Diffusion Tensor Imaging (MRI-DTI) before the treatment * Neurocognitive function test before the treatment 2. Assessment of clinical condition in the course by measurement of blood pressure, heart and respiratory rates, temperature and adverse events was recorded. 3. Autologous cord blood doses is 20-30ml (total Mononuclear cells\>1\*10\^7/kg),the infusion speed is 1ml/min, and with same volume of 0.9% sodium chloride as placebo. 4. The follow-up: clinical test until 30th month in 3 month gaps.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
0.9% Sodium Chloride in control group
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Cerebral Palsy for safety and effect evaluation.
Guangdong Women and Children's Hospital and Health Institute
Guangzhou, Guangdong, China
RECRUITINGThe Change of Gross Motor Function Classification System(GMFCS) Score
GMFCS is used to assess the gross motor function of the children who were diagnosised as cerebral palsy.The results of GMFCS are divided into five levels. Grade I represents the best outcome while grade Ⅴ represents the worst.
Time frame: up to 30 months after therapy at a 3-month interval
The Change of Gesell Developmental Scale(GDS) Score
The GDS is used to measure the gross motor,fine action,adaptability,language and individual-society function of the children whose age ranges from 1-month to 6-year-old. The score less than 75 for each subscale represent the worse outcome and more than 75 represent the better.
Time frame: every 3-month after therapy until 30 months
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