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

Vinmec Research Institute of Stem Cell and Gene Technology50 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sequelae of Injuries of Head

Interventions

autologous bone marrow-derived mononuclear cell transplantationBIOLOGICAL

Bm-MNC will be transplanted at baseline, and the second transplantation will be performed 6 months after the first transplantation

Rehabilitation therapyOTHER

Rehabilitation therapy

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Hanoi, Vietnam

Outcomes

Primary Outcomes

Adverse events and serious adverse events

Incidence of the adverse events or serious adverse events after transplantation

Time frame: up to the 12-month period following treatment

Functional Independence Measure

Functional Independence Measure assess and grade the functional status of patient

Time frame: up to the 12-month period following treatment

Extended Glasgow Outcome Scale

Extended Glasgow Outcome Scale classifies global outcome in TBI survivors

Time frame: up to the 12-month period following treatment

Secondary Outcomes

Short Form 36

Short Form 36 items will be performed to evaluate the overall health of the patients for their quality of life

Time frame: 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

Time frame: up to the 12 months after transplantation

Data from ClinicalTrials.gov

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