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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (BM-MNC trasnplatation) | Experimental | 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 |
|
| Control group | Other | rehabilitation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinmec Research Institute of Stem Cell and Gene Technology | Hanoi | Hanoi | 100000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30107811 | Result | Nguyen TL, Nguyen HP, Nguyen TK. The effects of bone marrow mononuclear cell transplantation on the quality of life of children with cerebral palsy. Health Qual Life Outcomes. 2018 Aug 14;16(1):164. doi: 10.1186/s12955-018-0992-x. | |
| 28403842 | Result | 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. |
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| Rehabilitation therapy | Other | Rehabilitation therapy |
|
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 |
| 31692977 | Result | Eggenberger S, Boucard C, Schoeberlein A, Guzman R, Limacher A, Surbek D, Mueller M. Stem cell treatment and cerebral palsy: Systemic review and meta-analysis. World J Stem Cells. 2019 Oct 26;11(10):891-903. doi: 10.4252/wjsc.v11.i10.891. |
| 28296862 | Result | Bansal H, Verma P, Agrawal A, Leon J, Sundell IB, Koka PS. A Short Study Report on Bone Marrow Aspirate Concentrate Cell Therapy in Ten South Asian Indian Patients with Autism. J Stem Cells. 2016;11(1):25-36. |
| 17370477 | Result | Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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