Sequelae of Injuries of HeadPhase 1/2NCT05293873
Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae
A Phase 1/2 study testing autologous bone marrow-derived mononuclear cell transplantation and Rehabilitation therapy in people with Sequelae of Injuries of Head, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Sequelae of Injuries of Head
- What is being tested?
- autologous bone marrow-derived mononuclear cell transplantation and Rehabilitation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Apr 2021to 30 Jun 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: from 20 to 50 years
- Gender: either sex
- Duration after Brain trauma: 6 - 12 months
- Functional Independence Measure - FIM < 69
- Closed head injury
Who cannot join
- 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
Show all 9Show fewer
- Alcoholic
- Patient was unemployed or did not attend school before the accident.
- Severe injuries: spinal cord injury, pelvic inflammation, cardiopulmonary
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Hanoi, 100000
About this study
Official title: Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae After Traumatic Brain Injury
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
Read the 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).
- Conditions
- Sequelae of Injuries of Head
- Being tested
- autologous bone marrow-derived mononuclear cell transplantation, Rehabilitation therapy
- Keywords
- traumatic brain injury, mononuclear cell, neurological sequelae
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow-derived mononuclear cell transplantationBiological
Bm-MNC will be transplanted at baseline, and the second transplantation will be performed 6 months after the first transplantation
Rehabilitation therapyOther
Rehabilitation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: autologous bone marrow-derived mononuclear cell transplantation; Other: Rehabilitation therapy |
| Control group | Other | rehabilitation therapy Receives: Other: Rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and serious adverse events
Incidence of the adverse events or serious adverse events after transplantation
Measured: up to the 12-month period following treatment
Functional Independence Measure
Functional Independence Measure assess and grade the functional status of patient
Measured: up to the 12-month period following treatment
Extended Glasgow Outcome Scale
Extended Glasgow Outcome Scale classifies global outcome in TBI survivors
Measured: up to the 12-month period following treatment
Secondary outcomes (2)
Short Form 36
Short Form 36 items will be performed to evaluate the overall health of the patients for their quality of life
Measured: up to the 12-month period following treatment
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
Measured: up to the 12 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Apr 2021
- Primary completion30 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sequelae of Injuries of HeadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293873
- Sponsor's protocol ID
- VinmecISC1805
- Status last verified
- Sep 2024
- First submitted
- 27 Mar 2019
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30107811Nguyen 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.
PubMed 28403842Eggenberger 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.
PubMed 31692977Bansal 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.
PubMed 28296862Rosenbaum 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.
PubMed 17370477
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05293873
- Acronym / sponsor ID
- VinmecISC1805
- Conditions
- Sequelae of Injuries of Head
- Keywords
- traumatic brain injury, mononuclear cell, neurological sequelae
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene TechnologyUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (BM-MNC trasnplatation) | Experimental | Biological: autologous bone marrow-derived mononuclear cell transplantation, Other: Rehabilitation therapyAutologous 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 | Other: Rehabilitation therapyrehabilitation therapy |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: from 20 to 50 years
- Gender: either sex
- Duration after Brain trauma: 6 - 12 months
- Functional Independence Measure - FIM < 69
- Closed head injury
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous bone marrow-derived mononuclear cell transplantationBm-MNC will be transplanted at baseline, and the second transplantation will be performed 6 months after the first transplantation | Biological | Treatment (BM-MNC trasnplatation) |
| Rehabilitation therapyRehabilitation therapy | Other | Control group, Treatment (BM-MNC trasnplatation) |
Primary outcome
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
Functional Independence Measure
Time frame: up to the 12-month period following treatment
Functional Independence Measure assess and grade the functional status of patient
Extended Glasgow Outcome Scale
Time frame: up to the 12-month period following treatment
Extended Glasgow Outcome Scale classifies global outcome in TBI survivors
2 secondary outcomes
Short Form 36
Time frame: up to the 12-month period following treatment
to monitor the functional metabolic changes in the brain of the patients
Time frame: up to the 12 months after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Results publication: PubMed 30107811Nguyen 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.
- Results publication: PubMed 28403842Nguyen 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 publication: PubMed 31692977Eggenberger 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.
- Results publication: PubMed 28296862Bansal 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.
- Results publication: PubMed 17370477Rosenbaum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing autologous bone marrow-derived mononuclear cell transplantation and Rehabilitation therapy in people with Sequelae of Injuries of Head, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and serious adverse events (time frame: up to the 12-month period following treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05293873, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.