Estimation of the Safety and Efficiency Transfusion of HLA Matched CBU in Patients With CP

Launched by STATE-FINANCED HEALTH FACILITY "SAMARA REGIONAL MEDICAL CENTER DINASTY" · Sep 19, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of using umbilical cord blood, which is collected from the placenta after a baby is born, as a treatment for children with cerebral palsy (CP). Cerebral palsy is a condition that affects movement and posture due to injury to the brain that occurs before or during birth. The study aims to see if using umbilical cord blood that matches the child’s tissue can help improve their condition, based on promising results from earlier studies.

Children aged 1 to 12 years who have been diagnosed with cerebral palsy may be eligible to participate, as long as they have a compatible cord blood sample available. Participants will be carefully monitored throughout the trial to assess how well the treatment works and to ensure their safety. It’s important to note that children with certain medical conditions or those outside the age range will not be able to join the study. If you are considering this for your child, you will need to provide consent, and the research team will guide you through the process.

Gender

ALL

Eligibility criteria

• 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.