Allogenic Cord Blood Transfusion in Patients With Autism

Phase 1

Completed

Lead Sponsor: State-Financed Health Facility "Samara Regional Medical Center Dinasty"

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 behavior, while the therapeutic effect of current treatments remains limited progress.

The possible reason for ASD is neural hypoperfusion and immune deregulation. The Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. In this study, the safety and efficacy of hUCB-MNCs infusion will be evaluated in patients with Autism.

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 social interaction and communication, as well as the presence of repetitive and stereotyped behaviors. Recent reports of a sharp increase in the number of children with autism. The exact etiology of autism remains unclear. Compliance, the definition of effective treatments for autism is particularly difficult.

Although it has been understood, it can be a question of immune dysregulation. Examination of the inflammatory cytokines, dysfunction of the immune system and the immune system. The Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. The Our study suggest that infusion of cord blood mononuclear cells will affect Autism.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

organic pathology of the brain according to CT, MRI
the presence of the following diseases in history: heart failure in the stage of decompensation, stroke in history less than 1 year ago, blood diseases;
decompensation of chronic and endocrinological diseases;
acute respiratory viral and bacterial infections, period less than 1 month after the acute phase.
HIV infection, hepatitis B and C.
oncological diseases, chemotherapy in the anamnesis;
tuberculosis.
Severe form of intellectual disability.
Cerebral palsy.
epilepsy.

Arm && Interventions

Group	Intervention	Description
ASD CB-MNC injection.	ASD CB-MNC injection.	ASD CB-MNC injection from different donors and standard therapy.
ASD CB-MNC injection.	Standard therapy.	ASD CB-MNC injection from different donors and standard therapy.
Standard therapy.	Standard therapy.	Patients with standard therapy as control group.

Primary Outcome Measures

Name	Time	Method
Autism Treatment Evaluation Checklist (ATEC).	score at baseline, 1, 2, 6, 12 months	The ATEC is designed to measure changes in the severity of ASD in response to treatment. A total score and 4 subscale scores are reported. Questions in the first 3 subscales are scored using a 0-3 scale (not true/partially true/absolutely true). The 4 subscale, Health/Physical/Behavior, is scored using a 0-4 point scale (Not a problem/Minor problem/Moderate problem/Serious problem). The first subscale, Speech/Language/Communication, contains 14 items where the score ranges from 0-28 points. The Sociability subscale contains 20 items and participants can score from 0-40. The third subscale, Sensory/Cognitive awareness, has 18 items and scores range from 0-36. Finally, the Health/Physical/Behavior subscale contains 25 items and scores range from 0-75. The scores from each subscale are combined in order to calculate a Total Score, which ranges from 0 to179 points. A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD.
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion	24hrs post transfusion	Safety assessment. The adverse events rate will be assessed in all patients.

Secondary Outcome Measures

Name	Time	Method
Cytokine Analysis.	score at baseline, 1, 2, 6 months	IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood
Immune Status as Determined by Percentage of Peripheral Blood Cells	score at baseline, 6 month	Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (%)
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells	score at baseline, 6 month	Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (absolute v.)