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

Spastic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03107975
• Other study ID #: SC-CP
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: April 5, 2017
• Last updated: April 24, 2017
• Start date: April 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2017
• Source: The Second Affiliated Hospital of Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paralysis
• Spastic Cerebral Palsy

Intervention

Biological:
• human amniotic epithelial cells
intrathecal injection of human amniotic epithelial cells

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Fujian Medical University	Quanzhou	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Fujian Medical University	Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fine Motor Function Measure	The fine motor performance is evaluated by using Fine Motor Function Measure.	6 months
Secondary	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
Secondary	Gesell Developmental Scales	Neurodevelopmental evaluation with the Gesell Developmental Schedules was performed.	6 months