Effect of Drugs, Safety Issues
Conditions
Keywords
Cerebral palsy, Autologous Umbilical Cord Blood, safety, effect
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.
Interventions
DRUG0.9% Sodium Chloride
0.9% Sodium Chloride in control group
BIOLOGICALAutologous Umbilical Cord Blood
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Cerebral Palsy for safety and effect evaluation.
Sponsors
Guangdong Women and Children Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
No
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.. * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactXiao Huimei, MD
Backup ContactChang Yanqun, Phd
Outcome results
None listed