Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae
NCT ID: NCT05293873
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2021-04-01
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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
Rehabilitation therapy
Rehabilitation therapy
Control group
rehabilitation therapy
Rehabilitation therapy
Rehabilitation therapy
Interventions
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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
Rehabilitation therapy
Rehabilitation therapy
Eligibility Criteria
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Inclusion Criteria
* Gender: either sex
* Duration after Brain trauma: 6 - 12 months
* Functional Independence Measure - FIM \< 69
* Closed head injury
Exclusion Criteria
* 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
20 Years
50 Years
ALL
No
Sponsors
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Vinmec Research Institute of Stem Cell and Gene Technology
OTHER
Responsible Party
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Locations
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Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Hanoi, Vietnam
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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VinmecISC1805
Identifier Type: -
Identifier Source: org_study_id
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