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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05293873
Recruitment Status : Recruiting
First Posted : March 24, 2022
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Vinmec Research Institute of Stem Cell and Gene Technology

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

Condition or disease Intervention/treatment Phase
Sequelae of Injuries of Head Biological: autologous bone marrow-derived mononuclear cell transplantation Other: Rehabilitation therapy Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae After Traumatic Brain Injury
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
Experimental: Treatment (BM-MNC trasnplatation)
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
Bm-MNC will be transplanted at baseline, and the second transplantation will be performed 6 months after the first transplantation

Other: Rehabilitation therapy
Rehabilitation therapy

Control group
rehabilitation therapy
Other: Rehabilitation therapy
Rehabilitation therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05293873


Contacts
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Contact: Liem T Nguyen, MD., PhD (+844)39743556 ext 1420 v.liemnt@vinmec.com
Contact: Kien T Nguyen, Msc (+84)386958552 v.kiennt25@vinmec.com

Locations
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Vietnam
Vinmec Research Institute of Stem Cell and Gene Technology Recruiting
Hanoi, Vietnam, 100000
Contact: Liem T Nguyen, MD., PhD    (+844)39743556 ext 1420    v.liemnt@vinmec.com   
Vinmec Research Institute of Stem Cell and Gene Technology Recruiting
Hanoi, Vietnam, 100000
Contact: Nguyễn T Liem, Prof         
Sponsors and Collaborators
Vinmec Research Institute of Stem Cell and Gene Technology
Publications of Results:
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Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT05293873    
Other Study ID Numbers: VinmecISC1805
First Posted: March 24, 2022    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vinmec Research Institute of Stem Cell and Gene Technology:
traumatic brain injury
mononuclear cell
neurological sequelae
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Nervous System Diseases
Trauma, Nervous System