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

NCT ID: NCT03107975

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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).

Conditions

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Spastic Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cell Therapy

intrathecal injection of human amniotic epithelial cells

Group Type EXPERIMENTAL

human amniotic epithelial cells

Intervention Type BIOLOGICAL

intrathecal injection of human amniotic epithelial cells

Interventions

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human amniotic epithelial cells

intrathecal injection of human amniotic epithelial cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

INDUSTRY

Sponsor Role collaborator

The Second Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongzhi Gao, Dr.

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Fujian Medical University

Locations

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The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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SC-CP

Identifier Type: -

Identifier Source: org_study_id

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