Cerebral palsy
Conditions
Interventions
1:ANGE-S001
2:Placebo (ange-s001 analogue)Placebo (ANGE-S001 analogue)
Sponsors
First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
1 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1) the patient was diagnosed as cerebral palsy caused by ischemia and hypoxia, mainly including neonatal asphyxia and premature infants; 2) aged 1-6 years, gender not limited; 3) clinical manifestations of spastic cerebral palsy; 4) GMFCS is classified as grade ii-iv; 5) participate in the study voluntarily and sign the informed consent by himself or his legal representative.
Exclusion criteria
Exclusion criteria: 1) systemic diseases that may interfere with the treatment of children or interfere with the compliance of children; 2) life-threatening diseases associated with various organ systems; 3) children with brain malformation; 4) there is uncontrolled epilepsy; 5) children with behavioral or emotional disorders; 6) allergic constitution, especially for children allergic to blood products; 7) children who are infected with infectious diseases; 8) children with clinical studies of craniocerebral surgery before screening; 9) participated in other clinical studies/researchers in the past 3 months; 10) those deemed by the researcher as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMFM-88 total score change or GMFM-66 percentage change; | — |
Secondary
| Measure | Time frame |
|---|---|
| FMFM;Modified Ashworth score;Gesell; | — |
Countries
China
Contacts
Public ContactDe Wu
First Affiliated Hospital of Anhui Medical University
Outcome results
None listed