Clinical trial NCT03786744: Allogenic Cord Blood Transfusion in Patients With Autism
Official title: Efficiency Evaluation of Allogenic Umbilical Cord Blood (UCB) Transfusion in Patients With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Autism Spectrum Disorder
Autism
Keywords: Autism, ASD, Cord blood
Lead sponsor: State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is prospective, non-randomized (open label) with control group study. The total 20 patient will be enrolled in this study. In 10 patient with ASD will be infused with umbilical corb blood. Other 10 patient with ASD will be treated with standard therapy (control group).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
timeFrame: 24hrs post transfusion
measure: Autism Treatment Evaluation Checklist (ATEC).
timeFrame: score at baseline, 1, 2, 6, 12 months
Secondary outcomes:
measure: Cytokine Analysis.
timeFrame: score at baseline, 1, 2, 6 months
measure: Immune Status as Determined by Percentage of Peripheral Blood Cells
timeFrame: score at baseline, 6 month
measure: Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
timeFrame: score at baseline, 6 month
Other outcomes:
Locations:
city: Samara
country: Russian Federation
facility: Medical Centre Dinasty
Study officials:
affiliation: Medical Centre Dinasty
name: STANISLAV VOLCHKOV, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: