NCT03791372

Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Guangdong Women and Children Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 10 Years
• Healthy volunteers: Not accepted

Summary

To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.

Detailed description

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.

Conditions

• Safety Issues
• Effect of Drugs

Interventions

Type	Name	Description
DRUG	0.9% Sodium Chloride	0.9% Sodium Chloride in control group
BIOLOGICAL	Autologous Umbilical Cord Blood	Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Cerebral Palsy for safety and effect evaluation.

Timeline

• Start date: 2017-10-10
• Primary completion: 2020-10-10
• Completion: 2021-04-10
• First posted: 2019-01-02
• Last updated: 2019-01-04

Locations

1 site across 1 country: China