Sequelae of Injuries of Head
Conditions
Keywords
traumatic brain injury, mononuclear cell, neurological sequelae
Brief 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).
Interventions
BIOLOGICALautologous 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
OTHERRehabilitation therapy
Rehabilitation therapy
Sponsors
Vinmec Research Institute of Stem Cell and Gene Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age: from 20 to 50 years * Gender: either sex * Duration after Brain trauma: 6 - 12 months * Functional Independence Measure - FIM \< 69 * Closed head injury
Exclusion criteria
* Neurologic impairment or neurological disease before the time of the accident. * Active infections * Tumours or failure of heart, lung, liver or kidney, respiratory distress syndrome * Anaemia, clotting disorder * Cancer * Pregnancy * Alcoholic * Patient was unemployed or did not attend school before the accident. * Severe injuries: spinal cord injury, pelvic inflammation, cardiopulmonary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and serious adverse events | up to the 12-month period following treatment | Incidence of the adverse events or serious adverse events after transplantation |
| Functional Independence Measure | up to the 12-month period following treatment | Functional Independence Measure assess and grade the functional status of patient |
| Extended Glasgow Outcome Scale | up to the 12-month period following treatment | Extended Glasgow Outcome Scale classifies global outcome in TBI survivors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form 36 | up to the 12-month period following treatment | Short Form 36 items will be performed to evaluate the overall health of the patients for their quality of life |
| to monitor the functional metabolic changes in the brain of the patients | up to the 12 months after transplantation | The PET-CT scan will be repeated to monitor the functional metabolic changes in the brain of the patients |
Countries
Vietnam
Outcome results
None listed