Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03791372
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Xiao Huimei, Guangdong Women and Children Hospital

Brief Summary:
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.

Condition or disease Intervention/treatment Phase
Safety Issues Effect of Drugs Drug: 0.9% Sodium Chloride Biological: Autologous Umbilical Cord Blood Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : October 10, 2020
Estimated Study Completion Date : April 10, 2021

Resource links provided by the National Library of Medicine


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 Name: Autologous Umbilical Cord Blood Mononuclear Cells Therapy




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03791372


Contacts
Layout table for location contacts
Contact: Xiao Huimei, MD +862039151772 ext +86 xiaowu2010727@163.com
Contact: Chang Yanqun, Phd +862039151772 ext +86 sfycyq@sina.com

Locations
Layout table for location information
China, Guangdong
Guangdong Women and Children's Hospital and Health Institute Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Chang Yanqun, Phd    +862039151772    sfycyq@sina.com   
Sponsors and Collaborators
Guangdong Women and Children Hospital
Investigators
Layout table for investigator information
Study Director: Chang Yanqun, Phd Guangdong Women and Children Hospital

Publications:
Layout table for additonal information
Responsible Party: Xiao Huimei, Professor, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT03791372     History of Changes
Other Study ID Numbers: GuangdongWCHRD
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiao Huimei, Guangdong Women and Children Hospital:
Cerebral palsy
Autologous Umbilical Cord Blood
safety
effect

Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases