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

Phase 1

• Conditions: Spastic Cerebral Palsy
• Interventions: Biological: human amniotic epithelial cells

• Registration Number: NCT03107975
• Lead Sponsor: The Second Affiliated Hospital of Fujian Medical University

Brief 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.

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).

Study Timeline

• Status Verified: 2017-04
• Study Start: 2017-04-01
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cell Therapy	human amniotic epithelial cells	intrathecal injection of human amniotic epithelial cells

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Gesell Developmental Scales	6 months	Neurodevelopmental evaluation with the Gesell Developmental Schedules was performed.
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.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Fujian Medical University; 🇨🇳 Quanzhou, Fujian, China