Safety Issues Clinical Trial
Official title:
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
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.
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