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Completed

NCT Number: NCT05293873

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

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

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Key information

Conditions

Sequelae of Injuries of Head Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous bone marrow-derived mononuclear cell transplantation

Biological

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

Rehabilitation therapy

Other

Rehabilitation therapy

Primary outcomes

  1. Adverse events and serious adverse events

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

    Incidence of the adverse events or serious adverse events after transplantation

  2. Functional Independence Measure

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

    Functional Independence Measure assess and grade the functional status of patient

  3. Extended Glasgow Outcome Scale

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

    Extended Glasgow Outcome Scale classifies global outcome in TBI survivors

Secondary outcomes

  1. Short Form 36

    Time frame: 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

  2. to monitor the functional metabolic changes in the brain of the patients

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2022
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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