Clinical trial NCT05293873: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sequelae of Injuries of Head
Keywords: traumatic brain injury
mononuclear cell
neurological sequelae
Lead sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Adverse events and serious adverse events
timeFrame: up to the 12-month period following treatment
measure: Functional Independence Measure
timeFrame: up to the 12-month period following treatment
measure: Extended Glasgow Outcome Scale
timeFrame: up to the 12-month period following treatment
Secondary outcomes:
measure: Short Form 36
timeFrame: up to the 12-month period following treatment
measure: to monitor the functional metabolic changes in the brain of the patients
timeFrame: up to the 12 months after transplantation
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
References:
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.