We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 5, 2017
First Posted Date  ICMJE April 11, 2017
Last Update Posted Date April 26, 2017
Actual Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • Fine Motor Function Measure [ Time Frame: 6 months ]
    The fine motor performance is evaluated by using Fine Motor Function Measure.
  • 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.
  • Gesell Developmental Scales [ Time Frame: 6 months ]
    Neurodevelopmental evaluation with the Gesell Developmental Schedules was performed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy
Official Title  ICMJE Effect of Intrathecal Transplant of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spastic Cerebral Palsy
Intervention  ICMJE Biological: human amniotic epithelial cells
intrathecal injection of human amniotic epithelial cells
Study Arms  ICMJE Experimental: Cell Therapy
intrathecal injection of human amniotic epithelial cells
Intervention: Biological: human amniotic epithelial cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 5, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03107975
Other Study ID Numbers  ICMJE SC-CP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party The Second Affiliated Hospital of Fujian Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Second Affiliated Hospital of Fujian Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Investigators  ICMJE
Principal Investigator: Hongzhi Gao, Dr. The Second Affiliated Hospital of Fujian Medical University
PRS Account The Second Affiliated Hospital of Fujian Medical University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP