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Safety and Efficacy of the Transfusion of UCB in Patients With an ASD Depending on the Degree of HLA Compatibility.

NCT04099381 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-01-18

No results posted yet for this study

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 dysregulation. 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 with regarding to HLA compatibility.

Conditions

Interventions

BIOLOGICAL

ASD CB-MNC infusion low level HLA compatibility.

CB-MNC infusion from different donors. One dose consists of 2-15х10\^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of the cord blood is 3 or fewer by A, B, DRB1 loci.

BIOLOGICAL

ASD CB-MNC infusion high level HLA compatibility.

CB-MNC infusion from different donors. One dose consists of 2-15х10\^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of the cord blood is 4 or more by A, B, DRB1 loci.

OTHER

Standard therapy.

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

Sponsors & Collaborators

  • INBIO, LLC

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • STANISLAV VOLCHKOV, MD, PhD · Medical Centre Dinasty

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-10
Primary Completion
2023-12-26
Completion
2024-05-26

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04099381 on ClinicalTrials.gov