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NCT05293873

Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae

Completed Phase 1, PHASE2 Last updated 1 October 2024
What this trial tests

Phase 1, PHASE2 trial testing autologous bone marrow-derived mononuclear cell transplantation in Sequelae of Injuries of Head in 50 participants. Completed in 30 June 2023.

Timeline
1 April 2021
Primary endpoint
30 March 2023
30 June 2023

Quick facts

Lead sponsorVinmec Research Institute of Stem Cell and Gene Technology
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment50
Start date1 April 2021
Primary completion30 March 2023
Estimated completion30 June 2023
Sites1 location across Vietnam

Drugs / interventions tested

Conditions studied

Sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Who can join

Adults 20 to 50, any sex, with Sequelae of Injuries of Head. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in the management of neurological sequelae after traumatic brain injury

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Backpack-mediated anti-inflammatory macrophage cell therapy for the treatment of traumatic brain injury.
    Kapate N, Liao R, Sodemann RL, Stinson T, et al · · 2024 · cited 16× · PMID 38187808 · DOI 10.1093/pnasnexus/pgad434
  2. Autologous bone marrow mononuclear cell administration for neurological sequelae after traumatic brain injury: a matched control study.
    Nguyen LT, Thi Huong Ha G, Trung Nguyen K, Thanh Hoang V, et al · · 2025 · PMID 41063968 · DOI 10.1093/braincomms/fcaf361

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Other Vinmec Research Institute of Stem Cell and Gene Technology trials

Trials by the same sponsor.

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