Neurological sequelae after traumatic brain injury impair motor and behavioural functions, imposing a heavy burden on patients and society. Traditional treatments show limited efficacy, highlighting the need for advanced therapies. This study evaluated the safety and efficacy of intrathecal administration of bone marrow mononuclear cells for treating these sequelae. A matched control clinical trial was conducted on 50 patients. The intervention group received two intrathecal infusions of bone marrow mononuclear cells, 6 months apart, combined with rehabilitation therapy, while the control group received rehabilitation therapy only. Safety was assessed through adverse events and serious adverse events. Effectiveness was measured via the Functional Independence Measure, Short Form-36 Quality of Life Questionnaire and Glasgow Outcome Scale-Extended. MRI and PET-CT imaging monitored brain changes in the intervention group. No serious adverse events were reported during 12 months of follow-up. Mild adverse events, such as pain at the aspiration site and dizziness, were self-limiting. The intervention group showed significant improvements in motor scores (+4.3 points; P = 0.02) and cognitive scores (+1.7 points; P = 0.009). Quality of life scores in physical and mental domains improved significantly (P < 0.05). MRI revealed structural improvements, while PET-CT indicated enhanced metabolic activity in the brain. Intrathecal administration of bone marrow mononuclear cells is safe and effective in improving motor function and quality of life in patients with neurological sequelae after traumatic brain injury. This therapy is recommended as a complementary treatment alongside rehabilitation therapy.
