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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Sequelae of Injuries of Head

Intervention / Treatment
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* Biological: autologous bone marrow-derived mononuclear cell transplantation
* Other: Rehabilitation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (BM-MNC trasnplatation)<br>Autologous bone marrow-derived mononuclear cell will transplant at baseline, and the second transplantation will be performed 6 months after the first transplantation and combination with rehabilitation therapy | Biological: autologous bone marrow-derived mononuclear cell transplantation<br>* Bm-MNC will be transplanted at baseline, and the second transplantation will be performed 6 months after the first transplantation<br>Other: Rehabilitation therapy<br>* Rehabilitation therapy<br>|
| Other: Control group<br>rehabilitation therapy | Other: Rehabilitation therapy<br>* Rehabilitation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and serious adverse events | Incidence of the adverse events or serious adverse events after transplantation | up to the 12-month period following treatment | 
| Functional Independence Measure | Functional Independence Measure assess and grade the functional status of patient | up to the 12-month period following treatment | 
| Extended Glasgow Outcome Scale | Extended Glasgow Outcome Scale classifies global outcome in TBI survivors | up to the 12-month period following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36 | Short Form 36 items will be performed to evaluate the overall health of the patients for their quality of life | up to the 12-month period following treatment | 
| to monitor the functional metabolic changes in the brain of the patients | The PET-CT scan will be repeated to monitor the functional metabolic changes in the brain of the patients | up to the 12 months after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury, mononuclear cell, neurological sequelae