Status:
UNKNOWN
Safety and Efficacy of the Transfusion of UCB in Patients With an ASD Depending on the Degree of HLA Compatibility.
Lead Sponsor:
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Collaborating Sponsors:
INBIO, LLC
Conditions:
Autism Spectrum Disorder
Autism
Eligibility:
All Genders
3-14 years
Phase:
PHASE1
PHASE2
Brief Summary
Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive be...
Detailed Description
Autism Spectrum Disorders (ASD) are heterogeneous neuro-developed disorders. Autism is the most common disorder of the diseases characterized by dysfunctions in response to social interaction and comm...
Eligibility Criteria
Inclusion
- Patient selection criteria (indications for this type of treatment):
- Patient's age from 4 to 14 years;
- Diagnosis: autistic spectrum disorder;
- The severity of the disease on the ATEC scale of at least 16 points;
- The presence of a compatible allogeneic sample suitable for infusion;
- Parental consent (official guardians).
- Patient exclusion criteria (contraindications for this type of treatment):
- The patient's age under 4 years, after 14 years;
- The presence of the following diseases in the history: heart failure at the stage of decompensation, stroke in the history of less than 1 year ago, anemia and other blood diseases;
- Decompensation for chronic and endocrinological diseases;
- Acute viral and bacterial infections during the acute clinical phase of the disease;
- HIV infection, hepatitis B and C;
- Cancer, chemotherapy, and history of cancer;
- Tuberculosis;
- Severe form of intellectual disability as a concomitant disease (diagnosis can be ignored, according to the decision of the Medical Committee of the Center);
- Fragile X chromosome syndrome;
- Epileptic seizures with or without medication in the last 6 months before inclusion in the protocol.
Exclusion
Key Trial Info
Start Date :
August 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 26 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04099381
Start Date
August 10 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