Intranasal Inhalations of Bioactive Factors Produced by M2 Macrophages in Patients With Organic Brain Syndrome
Organic Brain Syndrome, Nonpsychotic, Neurocognitive Disorders, Mental Disorder, Organic
About this trial
This is an interventional treatment trial for Organic Brain Syndrome, Nonpsychotic focused on measuring macrophages M2 type, cytokines, intranasal administration, neuroprotection, neuroregeneration, organic brain syndrome, neurocognitive disorders
Eligibility Criteria
Inclusion Criteria:
- Adults: age 18 - 80
- Persistent neurological deficits (cognitive, mental, motor, vestibular/ataxic disorders as a result of trauma, cardiovascular, neurodegenerative and others cerebral injuries), confirmed clinically and by CT or MRI
- A written informed consent of the patient or close relatives
Exclusion Criteria:
- Psychiatric disorders
- Seizures
- Severe dementia
- Hepatic or renal dysfunctions
- Hemodynamic or respiratory instability
- HIV or uncontrolled bacterial, fungal, or viral infections
- Pregnancy
- Malignancy
- Intolerance to gentamicin and / or multiple drug allergies
- Participation in other clinical trials
Sites / Locations
- Institute of Fundamental and Clinical Immunology
Arms of the Study
Arm 1
Experimental
Intranasal auto-M2-BFs
Intranasally-Administered Bioactive Factors, Produced by Autologous M2 Macrophage (auto-M2-BFs). M2 macrophages were generated in vitro from peripheral blood of patients during 7 days.Cell-free culture medium, containing auto-M2-BFs, was collected and aliquots of 2 mL/vial were cryopreserved. 30 patients with organic brain syndrome will receive auto-M2-BFs with the aerosol inhaler device (nebulizer), 2.0 mL once a day up to 30 days.