MedDataX Logo

Allogenic Cord Blood Transfusion in Patients With Autism

NCT ID: NCT03786744

Last Updated: 2020-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-12

Study Completion Date

2019-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder Autism

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Autism, ASD, Cord blood

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ASD CB-MNC injection.

ASD CB-MNC injection from different donors and standard therapy.

Group Type EXPERIMENTAL

ASD CB-MNC injection.

Intervention Type 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.

Intervention Type OTHER

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

Standard therapy.

Patients with standard therapy as control group.

Group Type OTHER

Standard therapy.

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

Standard therapy.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Volchkov Stanislav

Deputy director, Quality assurance director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

STANISLAV VOLCHKOV, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Centre Dinasty

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Centre Dinasty

Samara, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12112018

Identifier Type: -

Identifier Source: org_study_id