Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy

January 3, 2019 updated by: Xiao Huimei, Guangdong Women and Children Hospital
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1 clinical trial that constitutes two time points cohorts with participants who will receive intravenous autologous umbilical cord blood and 0.9% sodium chloride respectively. The timing of treatment is any time after the diagnosis of cerebral palsy. The investigator will proceed the groups during the same period.

  1. Demographic Data and Baseline Characteristics of the Studied Group were collected:

    • Basic patient's information survey
    • Medical history
    • Physical examination
    • Basic blood test result
    • Children's developmental disorders evaluation before the treatment
    • Brain Magnetic Resonance Imaging-Diffusion Tensor Imaging (MRI-DTI) before the treatment
    • Neurocognitive function test before the treatment
  2. Assessment of clinical condition in the course by measurement of blood pressure, heart and respiratory rates, temperature and adverse events was recorded.
  3. Autologous cord blood doses is 20-30ml (total Mononuclear cells>1*10^7/kg)，the infusion speed is 1ml/min, and with same volume of 0.9% sodium chloride as placebo.
  4. The follow-up: clinical test until 30th month in 3 month gaps.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chang Yanqun, Phd
  • Phone Number: +86 +862039151772
  • Email: sfycyq@sina.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangdong Women and Children's Hospital and Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A patient who was diagnosed with a mild case, and severity case of cerebral palsy or developmental disability through developmental assessment from more than two specialists including a specialist in pediatrics and rehabilitation medicine..
  • In case there is a sign of the general decrease in white matter, or periventricular leukomalacia near cerebral ventricles in MRI DTI test.
  • A subject who did a written consent to participation in this clinical trial through the very person and a legal representative.

Exclusion Criteria:

  • In case a patient underwent a surgical procedure, or was administered autologous cord blood within one year before participating in a clinical trial.
  • Accompanied by a serious disease, such as chromosome abnormality, etc.
  • In case where a patient's medical condition is judged to be maladapted by a researcher.
  • In case a patient or his or her legal representative doesn't agree to participation in a clinical trial.
  • A patient having a predisposition to allergies.
  • A patient having serious disorders in the liver, kidney, and cardiopulmonary function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min.
Drug: 0.9% Sodium Chloride
0.9% Sodium Chloride in control group
Experimental: Cord Blood Mononuclear Cells(CBMNC)
Autologous Umbilical Cord Blood Mononuclear Cells Therapy any time after the diagnosis of cerebral palsy, doses is 20-30ml (total Mononuclear cells>1*10^7/kg). The infusion speed is 1ml/min.
Biological: Autologous Umbilical Cord Blood
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Cerebral Palsy for safety and effect evaluation.
Other Names:
  • Autologous Umbilical Cord Blood Mononuclear Cells Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change of Gross Motor Function Classification System(GMFCS) Score
Time Frame: up to 30 months after therapy at a 3-month interval
GMFCS is used to assess the gross motor function of the children who were diagnosised as cerebral palsy.The results of GMFCS are divided into five levels. Grade I represents the best outcome while grade Ⅴ represents the worst.
up to 30 months after therapy at a 3-month interval
The Change of Gesell Developmental Scale(GDS) Score
Time Frame: every 3-month after therapy until 30 months
The GDS is used to measure the gross motor,fine action,adaptability，language and individual-society function of the children whose age ranges from 1-month to 6-year-old. The score less than 75 for each subscale represent the worse outcome and more than 75 represent the better.
every 3-month after therapy until 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Women and Children Hospital

Investigators

  • Study Director: Chang Yanqun, Phd, Guangdong Women and Children Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2017

Primary Completion (Anticipated)

October 10, 2020

Study Completion (Anticipated)

April 10, 2021

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

December 29, 2018

First Posted (Actual)

January 2, 2019

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GuangdongWCHRD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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