NCT05293873

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

Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae After Traumatic Brain Injury

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in 25 patients with neurological sequelae after traumatic brain injury compared with 25 patients in control group (no intervention) at the time points of baseline, 3rd month (D90), 6th month (D180), and 12th month (D360).

Conditions

• Sequelae of Injuries of Head

Interventions

Type	Name	Description
BIOLOGICAL	autologous bone marrow-derived mononuclear cell transplantation	Bm-MNC will be transplanted at baseline, and the second transplantation will be performed 6 months after the first transplantation
OTHER	Rehabilitation therapy	Rehabilitation therapy

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-03-30
• Completion: 2023-06-30
• First posted: 2022-03-24
• Last updated: 2024-10-01

Locations

1 site across 1 country: Vietnam