CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
ASD CB-MNC injection. +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03786744
NCT03786744Phase 2Completed
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Efficiency Evaluation of Allogenic Umbilical Cord Blood (UCB) Transfusion in Patients With Autism

State-Financed Health Facility "Samara Regional Medical Center Dinasty"·interventional·Posted Dec 26, 2018·Updated Nov 19, 2020

In Brief

A Phase 2 clinical trial evaluating ASD CB-MNC injection. and Standard therapy. for Autism Spectrum Disorder and Autism. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorder, Autism
CountriesRussia
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 26, 2018
Enrollment StartOct 12, 2018
Primary CompletionOct 12, 2019
Study CompletionDec 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 7.5 years ago

Interventions

ASD CB-MNC injection.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.other

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