Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
1 other identifier
interventional
25
1 country
1
Brief Summary
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2017
CompletedFirst Submitted
Initial submission to the registry
December 18, 2018
CompletedFirst Posted
Study publicly available on registry
January 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2021
CompletedJanuary 4, 2019
January 1, 2019
3 years
December 18, 2018
January 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Change of Gross Motor Function Classification System(GMFCS) Score
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
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
Study Arms (2)
Placebo
PLACEBO COMPARATOR0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min.
Cord Blood Mononuclear Cells(CBMNC)
EXPERIMENTALAutologous 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.
Interventions
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Cerebral Palsy for safety and effect evaluation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong Women and Children's Hospital and Health Institute
Guangzhou, Guangdong, 510010, China
Related Publications (1)
Sun JM, Song AW, Case LE, Mikati MA, Gustafson KE, Simmons R, Goldstein R, Petry J, McLaughlin C, Waters-Pick B, Chen LW, Wease S, Blackwell B, Worley G, Troy J, Kurtzberg J. Effect of Autologous Cord Blood Infusion on Motor Function and Brain Connectivity in Young Children with Cerebral Palsy: A Randomized, Placebo-Controlled Trial. Stem Cells Transl Med. 2017 Dec;6(12):2071-2078. doi: 10.1002/sctm.17-0102. Epub 2017 Oct 28.
PMID: 29080265BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chang Yanqun, Phd
Guangdong Women and Children Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 18, 2018
First Posted
January 2, 2019
Study Start
October 10, 2017
Primary Completion
October 10, 2020
Study Completion
April 10, 2021
Last Updated
January 4, 2019
Record last verified: 2019-01