deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT02957123

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

Safety/Efficacy of Intranasally-Administered Bioactive Factors Produced by Autologous M2 Macrophages in Patients With Organic Brain Syndrome

Sponsor: Russian Academy of Medical Sciences

Conditions Brain Ischemia Delirium, Dementia, Amnestic, Cognitive Disorders Encephalopathy, Ischemic Encephalopathy, Post-Traumatic, Chronic Mental Disorder, Organic Neurocognitive Disorders Nonpsychotic Organic Brain Syndrome Organic Brain Syndrome, Nonpsychotic Organic Mental Disorder
Interventions Intranasal auto-M2-BFs
Updated 11 times since 2017 Last updated: Feb 1, 2021 Started: Mar 31, 2016 Primary completion: Sep 30, 2020 Completion: Sep 30, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02957123, this PHASE1/PHASE2 trial focuses on Brain Ischemia and Delirium, Dementia, Amnestic, Cognitive Disorders and remains completed. Sponsored by Russian Academy of Medical Sciences, it has been updated 11 times since 2016, reflecting substantial change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

~Jan 2017 – ~Dec 2017 · 11 months · monthly snapshotRecruiting~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshotRecruiting~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshotRecruiting~Dec 2018 – ~Jan 2021 · 25 months · monthly snapshotRecruiting~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshotRecruiting~Mar 2021 – ~Dec 2022 · 21 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

11 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE1_PHASE2

▶ Show 6 earlier versions

  1. Mar 2021 — Dec 2022 [monthly]

    Completed PHASE1_PHASE2

    Status: Recruiting → Completed

  2. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE1_PHASE2

  3. Dec 2018 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  4. Jun 2018 — Dec 2018 [monthly]

    Recruiting PHASE1_PHASE2

  5. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  6. Jan 2017 — Dec 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Mar 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Russian Academy of Medical Sciences
Data source: Russian Academy of Medical Sciences

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations