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

Primary Purpose

Spastic Cerebral Palsy

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
human amniotic epithelial cells
Sponsored by
The Second Affiliated Hospital of Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • The Second Affiliated Hospital of Fujian Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cell Therapy

Arm Description

intrathecal injection of human amniotic epithelial cells

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fine Motor Function Measure
The fine motor performance is evaluated by using Fine Motor Function Measure.
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.
Gesell Developmental Scales
Neurodevelopmental evaluation with the Gesell Developmental Schedules was performed.

Full Information

First Posted
April 5, 2017
Last Updated
April 24, 2017
Sponsor
The Second Affiliated Hospital of Fujian Medical University
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT03107975
Brief Title
Effect of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy
Official Title
Effect of Intrathecal Transplant of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Fujian Medical University
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cell Therapy
Arm Type
Experimental
Arm Description
intrathecal injection of human amniotic epithelial cells
Intervention Type
Biological
Intervention Name(s)
human amniotic epithelial cells
Intervention Description
intrathecal injection of human amniotic epithelial cells
Primary Outcome Measure Information:
Title
Gross Motor Function Measure-66
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fine Motor Function Measure
Description
The fine motor performance is evaluated by using Fine Motor Function Measure.
Time Frame
6 months
Title
Modified Ashworth Scale
Description
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.
Time Frame
6 months
Title
Gesell Developmental Scales
Description
Neurodevelopmental evaluation with the Gesell Developmental Schedules was performed.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongzhi Gao, Dr.
Organizational Affiliation
The Second Affiliated Hospital of Fujian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Fujian Medical University
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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