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

NCT03107975 — Phase 1, Unknown, 10 participants, The Second Affiliated Hospital of Fujian Medical University

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

Registry	NCT03107975
Status	Unknown
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	10 (Estimated)
Sponsor	The Second Affiliated Hospital of Fujian Medical University (Other); collaborators: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Conditions	Spastic Cerebral Palsy
Interventions	human amniotic epithelial cells (Biological)
Dates	start 2017-04-01, primary completion 2017-12-31 (estimated), completion 2018-12-31 (estimated), first posted 2017-04-11, last updated 2017-04-26
Locations	1 site in China

-Summary

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

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+Detailed description

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).

+Arms and interventions

Arm	Type	Interventions	Description
Cell Therapy	Experimental	Biological: human amniotic epithelial cells	intrathecal injection of human amniotic epithelial cells

human amniotic epithelial cells (Biological): intrathecal injection of human amniotic epithelial cells

+Outcome measures

Primary outcomes

Gross Motor Function Measure-66 [6 months]: 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.

Secondary outcomes

Fine Motor Function Measure [6 months]: The fine motor performance is evaluated by using Fine Motor Function Measure.
Modified Ashworth Scale [6 months]: 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.
Gesell Developmental Scales [6 months]: Neurodevelopmental evaluation with the Gesell Developmental Schedules was performed.

+Eligibility

Sex: All, ages: 1 Year to 5 Years

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.

+Locations (1)

Facility	City	Country	Status
The Second Affiliated Hospital of Fujian Medical University	Quanzhou, Fujian	China

+Investigators

Hongzhi Gao, Dr., Principal investigator, The Second Affiliated Hospital of Fujian Medical University

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