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

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ClinicalTrials.gov Identifier: NCT03107975
Recruitment Status : Unknown
Verified April 2017 by The Second Affiliated Hospital of Fujian Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : April 11, 2017
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Information provided by (Responsible Party):
The Second Affiliated Hospital of Fujian Medical University

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.

Condition or disease Intervention/treatment Phase
Spastic Cerebral Palsy Biological: human amniotic epithelial cells Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intrathecal Transplant of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cell Therapy
intrathecal injection of human amniotic epithelial cells
Biological: human amniotic epithelial cells
intrathecal injection of human amniotic epithelial cells




Primary Outcome Measures :
  1. Gross Motor Function Measure-66 [ Time Frame: 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 Outcome Measures :
  1. Fine Motor Function Measure [ Time Frame: 6 months ]
    The fine motor performance is evaluated by using Fine Motor Function Measure.

  2. Modified Ashworth Scale [ Time Frame: 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.

  3. Gesell Developmental Scales [ Time Frame: 6 months ]
    Neurodevelopmental evaluation with the Gesell Developmental Schedules was performed.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107975


Locations
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China, Fujian
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China, 362000
Sponsors and Collaborators
The Second Affiliated Hospital of Fujian Medical University
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Investigators
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Principal Investigator: Hongzhi Gao, Dr. The Second Affiliated Hospital of Fujian Medical University
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Responsible Party: The Second Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT03107975    
Other Study ID Numbers: SC-CP
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations