Allogenic Cord Blood Transfusion in Patients With Autism

State-Financed Health Facility "Samara Regional Medical Center Dinasty"

Status and phase: Completed; Phase 2; Phase 1

Conditions: Autism Spectrum Disorder; Autism

Treatments: Other: Standard therapy.; Biological: ASD CB-MNC injection.

Study type: Interventional

Funder types: Other

Identifiers

NCT03786744

12112018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis: autistic type disorder (ASD).
• Systemic speech underdevelopment
• The presence of attention deficit hyperactivity disorder as a comorbid state
• Cognitive impairment

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

ASD CB-MNC injection.

Experimental group

Description:

ASD CB-MNC injection from different donors and standard therapy.

Treatment:

Biological: ASD CB-MNC injection.

Other: Standard therapy.

Standard therapy.

Other group

Description:

Patients with standard therapy as control group.

Treatment:

Other: Standard therapy.