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Intranasal Inhalations of M2 Macrophage Soluble Factors in Children With Developmental Speech Disorders

NCT04689282 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-05-02

No results posted yet for this study

Summary

The investigators have designed an innovative proof-of-concept trial designed to provide data as to whether the speech difficulties in children with developmental dysphasia (DD) are improved with intranasal inhalations of bioactive factors (BF), produced by macrophages of M2 phenotype (M2-BFs). The rationale for this approach is the ability of central nervous system (CNS) to repair and the important role of macrophages in the regulation of this process. It was found that type 2 macrophages (M2) have anti-inflammatory and neurorestorative potential, in contrast to pro-inflammatory and neurotoxic effects of М1 cells. The influence of M2 is largely realized through the production of a wide spectrum of bioactive factors (cytokines, chemokines, growth factors, neuropeptides, microvesicles etc) that inhibit inflammation, protect neurons from apoptosis, stimulate neurogenesis, the growth and remyelination of axons, the formation of new synapses and activate angiogenesis. This study uses M2-BFs, as therapeutic tool, and intranasal administration focusing on nose to brain transport, as a mode of delivery. Expected clinical effects in treated children: improvement of speech understanding, word formation, grammatical structure of speech and formation of coherent speech.

Conditions

  • Language Delay
  • Language; Developmental Disorder, Expressive
  • Language; Developmental Disorder, Receptive
  • Autism Spectrum Disorder
  • Attention Deficit-Hyperactivity Disorder
  • Speech Disorders in Children

Interventions

BIOLOGICAL

Bioactive Factors, Produced by M2 Type Macrophages (M2-BFs).

Intranasal delivery of M2-BFs is performed with the aerosol inhaler device (nebulizer), 2.0 mL once a day up to 30 days.

Sponsors & Collaborators

  • Russian Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Elena R Chernykh, MD, PhD · Institute of Fundamental and Clinical Immunology

  • Alexander A Ostanin, MD, PhD · Institute of Fundamental and Clinical Immunology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-09-01
Completion
2021-09-01

Countries

  • Russia

Study Locations

More Related Trials

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 NCT04689282 on ClinicalTrials.gov