Intranasal Inhalations of Bioactive Factors Produced by M2 Macrophages in Patients With Organic Brain Syndrome
Status:
Completed
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
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).