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Allogenic Cord Blood Transfusion in Patients With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03786744
Recruitment Status : Enrolling by invitation
First Posted : December 25, 2018
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Volchkov Stanislav, State-Financed Health Facility "Samara Regional Medical Center Dinasty"

Tracking Information
First Submitted Date  ICMJE December 21, 2018
First Posted Date  ICMJE December 25, 2018
Last Update Posted Date September 18, 2019
Actual Study Start Date  ICMJE October 12, 2018
Estimated Primary Completion Date October 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 25, 2018)
  • 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.
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 24, 2018)
  • Number of participants with non-serious and serious adverse events. [ Time Frame: baseline, change from baseline at 6 month ]
    Safety assessment
  • 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.
  • 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).
Change History Complete list of historical versions of study NCT03786744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2018)
  • 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
  • Immune status. [ Time Frame: baseline, change from baseline at 6 month ]
    Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogenic Cord Blood Transfusion in Patients With Autism
Official Title  ICMJE Efficiency Evaluation of Allogenic Umbilical Cord Blood (UCB) Transfusion in Patients With Autism
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Autism Spectrum Disorder
  • Autism
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: ASD CB-MNC injection.
    ASD CB-MNC injection from different donors and standard therapy.
    Interventions:
    • Biological: ASD CB-MNC injection.
    • Other: Standard therapy.
  • Standard therapy.
    Patients with standard therapy as control group.
    Intervention: Other: Standard therapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: December 24, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 12, 2019
Estimated Primary Completion Date October 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03786744
Other Study ID Numbers  ICMJE 12112018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Volchkov Stanislav, State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Study Sponsor  ICMJE State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: STANISLAV VOLCHKOV, MD, PhD Medical Centre Dinasty
PRS Account State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP