NCT03107975

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

April 5, 2017

Last Update Submit

April 24, 2017

Conditions

Spastic Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Fine Motor Function Measure

    6 months

  • Modified Ashworth Scale

    6 months

  • Gesell Developmental Scales

    6 months

Study Arms (1)

Cell Therapy

EXPERIMENTAL

intrathecal injection of human amniotic epithelial cells

Biological: human amniotic epithelial cells

Interventions

human amniotic epithelial cellsBIOLOGICAL

intrathecal injection of human amniotic epithelial cells

Cell Therapy

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Signed informed consent document;
  • Gross Motor Function Classification System (GMFCS) levels III-V;
  • Parents accepted voluntarily cell therapy for their children and followed-up.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, 362000, China

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hongzhi Gao, Dr.

    The Second Affiliated Hospital of Fujian Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 11, 2017

Study Start

April 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

CN(1)