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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03107975

Enrollment

Registered

2017-04-11

Start date

2017-04-01

Completion date

2018-12-31

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic Cerebral Palsy

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).

Interventions

BIOLOGICALhuman amniotic epithelial cells

intrathecal injection of human amniotic epithelial cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 5 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026