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Allogenic Cord Blood Transfusion in Patients With Autism

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ClinicalTrials.gov Identifier: NCT03786744
Recruitment Status : Enrolling by invitation
First Posted : December 25, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Volchkov Stanislav, 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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Autism Biological: ASD CB-MNC injection. Other: Standard therapy. Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficiency Evaluation of Allogenic Umbilical Cord Blood (UCB) Transfusion in Patients With Autism
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : May 12, 2019
Estimated Study Completion Date : December 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ASD CB-MNC injection.
ASD CB-MNC injection from different donors and standard therapy.
Biological: ASD CB-MNC injection.
CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.

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

Standard therapy.
Patients with standard therapy as control group.
Other: Standard therapy.
The standard therapy can include drugs, special psychology training etc.




Primary Outcome Measures :
  1. Number of participants with non-serious and serious adverse events. [ Time Frame: baseline, change from baseline at 6 month ]
    Safety assessment. Adverse events rate will be assessed in all patients.

  2. The Childhood Autism Rating Scale (CARS). [ Time Frame: baseline, change from baseline at 1, 2, 6 month ]
    Rating for behavior, characteristics, and abilities against the expected developmental growth. Will be assessed fifteen items, including: relationship to people; imitation; emotional response; body; object use; adaptation to change; visual response; listening response; taste-smell-touch response and use; fear and nervousness; verbal communication; non-verbal communication; activity level; level and consistency of intellectual response; general impressions. Total score will be assessed. Scores range form 15 to 60 with 30 being the cutoff rate for a diagnosis of mild autism. Scores 30-37 indicate mild to moderate autism, while scores between 38 and 60 are characterized as severe autism.

  3. Autism Treatment Evaluation Checklist (ATEC). [ Time Frame: baseline, change from baseline at 2, 3, 6 month ]
    Will be assessed: I. Speech/Language Communication (14 items); II. Sociability (20 items); III. Sensory/ Cognitive Awareness (18 items); and IV. Health/Physical/Behavior (25 items).


Secondary Outcome Measures :
  1. Cytokine analysis. [ Time Frame: baseline, change from baseline at 1, 2, 6 month ]
    IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood

  2. Immune status. [ Time Frame: baseline, change from baseline at 6 month ]
    Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56



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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786744


Locations
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Russian Federation
Medical Centre Dinasty
Samara, Russian Federation, 443095
Sponsors and Collaborators
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Investigators
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Principal Investigator: STANISLAV VOLCHKOV, MD, PhD Medical Centre Dinasty

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Responsible Party: Volchkov Stanislav, Deputy director, Quality assurance director, State-Financed Health Facility "Samara Regional Medical Center Dinasty"
ClinicalTrials.gov Identifier: NCT03786744     History of Changes
Other Study ID Numbers: 12112018
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Volchkov Stanislav, State-Financed Health Facility "Samara Regional Medical Center Dinasty":
Autism, ASD, Cord blood

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders