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Intranasal Inhalations of Bioactive Factors Produced by M2 Macrophages in Patients With Organic Brain Syndrome

NCT02957123 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-02-18

Study results available
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Summary

The investigators have designed an innovative proof-of-concept trial designed to provide data as to whether the treatment/rehabilitation efficacy and functional outcome of patients with organic brain syndrome are improved with intranasal inhalations of bioactive factors (BF), produced by autologous M2 macrophages (auto-M2-BFs). The rationale for this approach is the ability of central nervous system to repair and the important role of macrophages in the regulation of this process. It was found that type 2 macrophages have anti-inflammatory and reparative potential, whereas M1 cells possess pro-inflammatory and neurotoxic effects. Action of M2 macrophages is largely realized through the production a wide variety 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 auto-M2-BFs, as therapeutic agents and intranasal administration focusing on nose to brain transport, as a mode of delivery. Expected clinical effects in treated subjects: improvement of cognitive functions (memory, language, attention); correction of focal neurological deficit (paresis, spasticity, sensory disorders); reduction vestibular/ataxic disorders (vertigo, unsteadiness when walking); reduction of headaches; reduction of asthenia (weakness, fatigue); correction of emotional disorders (anxiety, depression).

Conditions

  • Organic Brain Syndrome, Nonpsychotic
  • Neurocognitive Disorders
  • Mental Disorder, Organic
  • Delirium, Dementia, Amnestic, Cognitive Disorders
  • Nonpsychotic Organic Brain Syndrome
  • Organic Mental Disorder
  • Encephalopathy, Post-Traumatic, Chronic
  • Encephalopathy, Ischemic
  • Brain Ischemia

Interventions

DRUG

Intranasal auto-M2-BFs

Delivery 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
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • Russia

Study Locations

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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 NCT02957123 on ClinicalTrials.gov