Status:
UNKNOWN
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
Lead Sponsor:
Guangdong Women and Children Hospital
Conditions:
Safety Issues
Effect of Drugs
Eligibility:
All Genders
6-10 years
Phase:
PHASE1
Brief Summary
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.
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 timi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03791372
Start Date
October 10 2017
End Date
April 10 2021
Last Update
January 4 2019
Active Locations (1)
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1
Guangdong Women and Children's Hospital and Health Institute
Guangzhou, Guangdong, China, 510010