Effect of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy

Study Overview
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Brief Summary
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This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy.

Detailed Description
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Cerebral palsy is one of the most common congenital (existing at or before birth) disorders of childhood.Spastic cerebral palsy causes stiffness and movement difficulties.There is no cure for the disease now. This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy. hAEC will be intrathecal transplanted. Functional status is determined by Gross Motor Function Measure-66 and Fine Motor Function Measure. Spasticity is evaluated by using modified Ashworth scale(MAS).

Official Title
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Effect of Intrathecal Transplant of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy

Conditions
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Spastic Cerebral Palsy

Intervention / Treatment
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* Biological: human amniotic epithelial cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent document; Gross Motor Function Classification System (GMFCS) levels III-V; Parents accepted voluntarily cell therapy for their children and followed-up. Exclusion Criteria: Have a history of severe allergic; Serological tests such as AIDS, hepatitis B, syphilis, etc; Hereditary metabolic diseases of nervous system; Tumor or Hematological diseases.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cell Therapy<br>intrathecal injection of human amniotic epithelial cells | Biological: human amniotic epithelial cells<br>* intrathecal injection of human amniotic epithelial cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Measure-66 | Gross Motor Function Measure-66 is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fine Motor Function Measure | The fine motor performance is evaluated by using Fine Motor Function Measure. | 6 months | 
| Modified Ashworth Scale | Spasticity is evaluated by using modified Ashworth scale.it is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement. | 6 months | 
| Gesell Developmental Scales | Neurodevelopmental evaluation with the Gesell Developmental Schedules was performed. | 6 months |