Status:
COMPLETED
Intranasal Inhalations of M2 Macrophage Soluble Factors in Children With Developmental Speech Disorders
Lead Sponsor:
Russian Academy of Medical Sciences
Conditions:
Language Delay
Language; Developmental Disorder, Expressive
Eligibility:
All Genders
3-18 years
Phase:
PHASE1
PHASE2
Brief 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 intr...
Detailed Description
Neuroinflammation plays a central role in the pathogenesis of any damage to the central nervous system (CNS) profoundly affecting the ability of neural cells to survive and to regenerate. Macrophages ...
Eligibility Criteria
Inclusion
- Age 3-18
- Speech disorders verified by speech therapist and neurologist
- Adequate hearing/vision to follow conversation
- Russian speaker
- A written informed consent of the parents/close relatives
Exclusion
- Acute infectious disease (bacterial, fungal, or viral)
- Seizures
- Intolerance to gentamicin and/or multiple drug allergies
- Participation in other clinical trials
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04689282
Start Date
February 1 2020
End Date
September 1 2021
Last Update
May 2 2022
Active Locations (1)
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1
Institute of Fundamental and Clinical Immunology
Novosibirsk, Russia, 630099