Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae
Primary Purpose
Sequelae of Injuries of Head
Status
Recruiting
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
autologous bone marrow-derived mononuclear cell transplantation
Rehabilitation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Sequelae of Injuries of Head focused on measuring traumatic brain injury, mononuclear cell, neurological sequelae
Eligibility 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
Sites / Locations
- Vinmec Research Institute of Stem Cell and Gene TechnologyRecruiting
- Vinmec Research Institute of Stem Cell and Gene TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment (BM-MNC trasnplatation)
Control group
Arm Description
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
rehabilitation therapy
Outcomes
Primary Outcome Measures
Adverse events and serious adverse events
Incidence of the adverse events or serious adverse events after transplantation
Functional Independence Measure
Functional Independence Measure assess and grade the functional status of patient
Extended Glasgow Outcome Scale
Extended Glasgow Outcome Scale classifies global outcome in TBI survivors
Secondary Outcome Measures
Short Form 36
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
The PET-CT scan will be repeated to monitor the functional metabolic changes in the brain of the patients
Full Information
NCT ID
NCT05293873
First Posted
March 27, 2019
Last Updated
March 14, 2022
Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
1. Study Identification
Unique Protocol Identification Number
NCT05293873
Brief Title
Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae
Official Title
Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae After Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sequelae of Injuries of Head
Keywords
traumatic brain injury, mononuclear cell, neurological sequelae
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (BM-MNC trasnplatation)
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Other
Arm Description
rehabilitation therapy
Intervention Type
Biological
Intervention Name(s)
autologous bone marrow-derived mononuclear cell transplantation
Intervention Description
Bm-MNC will be transplanted at baseline, and the second transplantation will be performed 6 months after the first transplantation
Intervention Type
Other
Intervention Name(s)
Rehabilitation therapy
Intervention Description
Rehabilitation therapy
Primary Outcome Measure Information:
Title
Adverse events and serious adverse events
Description
Incidence of the adverse events or serious adverse events after transplantation
Time Frame
up to the 12-month period following treatment
Title
Functional Independence Measure
Description
Functional Independence Measure assess and grade the functional status of patient
Time Frame
up to the 12-month period following treatment
Title
Extended Glasgow Outcome Scale
Description
Extended Glasgow Outcome Scale classifies global outcome in TBI survivors
Time Frame
up to the 12-month period following treatment
Secondary Outcome Measure Information:
Title
Short Form 36
Description
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
Title
to monitor the functional metabolic changes in the brain of the patients
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liem T Nguyen, MD., PhD
Phone
(+844)39743556
Ext
1420
Email
v.liemnt@vinmec.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kien T Nguyen, Msc
Phone
(+84)386958552
Email
v.kiennt25@vinmec.com
Facility Information:
Facility Name
Vinmec Research Institute of Stem Cell and Gene Technology
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liem T Nguyen, MD., PhD
Phone
(+844)39743556
Ext
1420
Email
v.liemnt@vinmec.com
Facility Name
Vinmec Research Institute of Stem Cell and Gene Technology
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nguyễn T Liem, Prof
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27800660
Citation
Cox CS Jr, Hetz RA, Liao GP, Aertker BM, Ewing-Cobbs L, Juranek J, Savitz SI, Jackson ML, Romanowska-Pawliczek AM, Triolo F, Dash PK, Pedroza C, Lee DA, Worth L, Aisiku IP, Choi HA, Holcomb JB, Kitagawa RS. Treatment of Severe Adult Traumatic Brain Injury Using Bone Marrow Mononuclear Cells. Stem Cells. 2017 Apr;35(4):1065-1079. doi: 10.1002/stem.2538. Epub 2016 Nov 23.
Results Reference
result
PubMed Identifier
28403842
Citation
Nguyen LT, Nguyen AT, Vu CD, Ngo DV, Bui AV. Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial. BMC Pediatr. 2017 Apr 12;17(1):104. doi: 10.1186/s12887-017-0859-z.
Results Reference
result
PubMed Identifier
25628985
Citation
Sharma A, Sane H, Kulkarni P, Yadav J, Gokulchandran N, Biju H, Badhe P. Cell therapy attempted as a novel approach for chronic traumatic brain injury - a pilot study. Springerplus. 2015 Jan 17;4:26. doi: 10.1186/s40064-015-0794-0. eCollection 2015.
Results Reference
result
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Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae
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