Allogenic Cord Blood Transfusion in Patients With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03786744
• Other study ID #: 12112018
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 12, 2018
• Est. completion date: December 12, 2019

Study information

• Verified date: October 2020
• Source: State-Financed Health Facility "Samara Regional Medical Center Dinasty"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 12, 2019
• Est. primary completion date: October 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Medical Centre Dinasty	Samara

Sponsors (1)

Lead Sponsor	Collaborator
State-Financed Health Facility "Samara Regional Medical Center Dinasty"

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion	Safety assessment. The adverse events rate will be assessed in all patients.	24hrs post transfusion
Primary	Autism Treatment Evaluation Checklist (ATEC).	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.	score at baseline, 1, 2, 6, 12 months
Secondary	Cytokine Analysis.	IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood	score at baseline, 1, 2, 6 months
Secondary	Immune Status as Determined by Percentage of Peripheral Blood Cells	Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (%)	score at baseline, 6 month
Secondary	Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells	Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (absolute v.)	score at baseline, 6 month