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

The Second Affiliated Hospital of Fujian Medical University

Status and phase: Unknown; Phase 1

Conditions: Spastic Cerebral Palsy

Treatments: Biological: human amniotic epithelial cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03107975

SC-CP

Details and patient eligibility

About

This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy.

Full 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).

Enrollment: 10 estimated patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Cell Therapy

Experimental group

Description:

intrathecal injection of human amniotic epithelial cells

Treatment:

Biological: human amniotic epithelial cells