Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
- Conditions
- Safety IssuesEffect of Drugs
- Interventions
- Biological: Autologous Umbilical Cord Blood
- Registration Number
- NCT03791372
- Lead Sponsor
- Guangdong Women and Children Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
- 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..
- In case there is a sign of the general decrease in white matter, or periventricular leukomalacia near cerebral ventricles in MRI DTI test.
- A subject who did a written consent to participation in this clinical trial through the very person and a legal representative.
- In case a patient underwent a surgical procedure, or was administered autologous cord blood 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 or her legal representative doesn't agree to participation in a clinical trial.
- 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 Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 0.9% Sodium Chloride 0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min. Cord Blood Mononuclear Cells(CBMNC) Autologous Umbilical Cord Blood Autologous Umbilical Cord Blood Mononuclear Cells Therapy any time after the diagnosis of cerebral palsy, doses is 20-30ml (total Mononuclear cells\>1\*10\^7/kg). The infusion speed is 1ml/min.
- Primary Outcome Measures
Name Time Method The Change of Gross Motor Function Classification System(GMFCS) Score up to 30 months after therapy at a 3-month interval 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.
The Change of Gesell Developmental Scale(GDS) Score every 3-month after therapy until 30 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Guangdong Women and Children's Hospital and Health Institute
🇨🇳Guangzhou, Guangdong, China