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| Name | Class |
|---|---|
| Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell Therapy | Experimental | intrathecal injection of human amniotic epithelial cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human amniotic epithelial cells | Biological | intrathecal injection of human amniotic epithelial cells |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongzhi Gao, Dr. | The Second Affiliated Hospital of Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Fujian Medical University | Quanzhou | Fujian | 362000 | China |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 6 months |
| Gesell Developmental Scales | Neurodevelopmental evaluation with the Gesell Developmental Schedules was performed. | 6 months |