Status:
UNKNOWN
Estimation of the Safety and Efficiency Transfusion of HLA Matched CBU in Patients With CP
Lead Sponsor:
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Collaborating Sponsors:
INBIO, LLC
Conditions:
Cerebral Palsy
Eligibility:
All Genders
1-12 years
Phase:
PHASE2
Brief Summary
Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood-onset disability. Many experimental ani...
Detailed Description
Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability...
Eligibility Criteria
Inclusion
- Patient selection criteria (indications for this type of treatment):
- Patient age from 1 to 12 years;
- Diagnosis: cerebral palsy, including postnatal damage after ischemic or hemorrhagic strokes, hypoxic or ischemic encephalopathy, periventricular leucomalacia;
- The presence of I - V lesion levels on the GMFCS - ER (CanChild) scale;
- The presence of a compatible allogeneic sample suitable for infusion;
- Parental consent (official guardians)
- Patient exclusion criteria (contraindications for this type of treatment):
- Patient age up to 1 year, older than 12 years;
- The presence of the following diseases in history: heart failure in the stage of decompensation, anemia and other blood diseases;
- Decompensation of chronic and endocrinological diseases;
- Acute viral and bacterial infections during the acute clinical phase of the disease;
- HIV infection, hepatitis of B and C types;
- Oncological diseases, chemotherapy in the anamnesis;
- Tuberculosis;
- Confirmed genetic disorders;
- A severe form of intellectual disability as a concomitant disease (diagnosis can be ignored, according to the decision of the Medical Committee of the Center);
- Epileptic seizures with or without medication in the last 6 months before inclusion in the protocol.
Exclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 26 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04098029
Start Date
September 1 2019
End Date
May 26 2024
Last Update
January 18 2023
Active Locations (1)
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1
Medical Centre Dinasty
Samara, Russia, 443095