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Completed

NCT Number: NCT03786744

Allogenic Cord Blood Transfusion in Patients With Autism

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.

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Key information

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medical Centre Dinasty

Samara, 443095, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASD CB-MNC injection.

Biological

CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.

Standard therapy.

Other

The standard therapy can include drugs, special psychology training etc.

Primary outcomes

  1. A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion

    Time frame: 24hrs post transfusion

    Safety assessment. The adverse events rate will be assessed in all patients.

  2. Autism Treatment Evaluation Checklist (ATEC).

    Time frame: 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.

Secondary outcomes

  1. Cytokine Analysis.

    Time frame: score at baseline, 1, 2, 6 months

    IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood

  2. Immune Status as Determined by Percentage of Peripheral Blood Cells

    Time frame: score at baseline, 6 month

    Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (%)

  3. Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells

    Time frame: score at baseline, 6 month

    Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (absolute v.)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Efficiency Evaluation of Allogenic Umbilical Cord Blood (UCB) Transfusion in Patients With Autism

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 26, 2018
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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