Traumatic Brain InjuryPhase 2TRAUMACELLNCT06146062
Effects of Intravascular Administration of Mesenchymal Stromal Cells Derived from Wharton's Jelly of the Umbilical Cord on Systemic Immunomodulation and Neuroinflammation After Traumatic Brain Injury.
A Phase 2 study testing Mesenchymal Stromal Cells (MSC) in people with Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Traumatic brain injuries (TBI) are one of the leading causes of death and disability worldwide. These patients are burdened by physical, cognitive, and psychosocial deficits, leading to an important economic impact for society. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Mesenchymal Stromal Cells (MSC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 3 sitesFrance
- Study dates
- 25 Jun 2024to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years
- ASA 1 classification (healthy patient)
Who cannot join
- Lack of written consent
- Neurological history likely to alter the image (epilepsy, transient ischaemic attack, meningitis, head trauma)
- Vulnerable person according to article L1121-6 of the CSP
- Protected adult person
- No affiliation to a social security regime
- Pregnancy
Show all 52Show fewer
- Contraindication for MRI and PET-MRI
- patients with Pacemaker and defibrillator
- MR-incompatible prosthetic heart valve
- Metallic intraocular, intra cerebral or intra medullary foreign bodies
- Implantable neurostimulation systems
- Cochlear implants/ear implant
- Metallic fragments such as bullets, shotgun pellets, and metal shrapnel
- Cerebral artery aneurysm clips
- Ventriculo peritoneal shunt with metallic component generating significant artefacts on the MR sequence
- Catheters with metallic components (Swan-Ganz catheter)
- Patient unable to remain supine and motionless during the duration of the examination
- 68 severe TBI patients with the following inclusion and exclusion criteria will be included"
- Patient Inclusion criteria
- Age 18-50 years
- Severe TBI defined by:
- Glasgow score <12 within the 48 first hours,
- Brain traumatic lesion on CT scan,
- Need for intracranial pressure monitoring
- No other significant organ trauma (AIS <2)
- Unresponsive to verbal commands 5 days after sedation discontinuation, for whom, after usual clinical and paraclinical evaluation there has been no decision to interrupt active therapies within 10 days after sedation discontinuation
- Written consent signed by the close relative
- Patient Exclusion criteria
- History of disease or treatment impairing current or previous year immunity function ( hematologic disease (leukemia, myeloma), viral disease affecting immunity (like HIV), immunological treatment (corticoid, anti rejection medication, anti TNFα, chemotherapy)
- History of severe neurological or psychiatric disease likely to alter neurological assessment
- HTAP > grade III OMS/WHO
- Ongoing uncontrolled infection with organ failure (septic shock, ARDS) including those due to severe COVID-19
- Platelets <100 G/L or <100000/μL, Hb <8 g/dL, lymphocytes count <1.5 G/L or 1500 μL , neutrophils count < 2.5G/L or <2500/μL, , creatinin > 100 μmol/L
- Liver function abnormalities (bilirubin> 2.5mg / dL or transaminases> 5x the ULN). Patients with Gilbert's disease are eligible if liver tests are normal excluding bilirubinemia
- Known HIV seropositivity
- Neoplasia ongoing or treated in the 3 years before screening
- Bone marrow transplant recipient
- History of transfusion reaction or hypersensitivity
- Pregnancy
- Contraindication for MRI and PET-MRI:
- Patient with Pacemaker and defibrillator
- MR-incompatible prosthetic heart valve o Metallic intraocular, intra cerebral or intra medullary foreign bodies
- Implantable neurostimulation systems o Cochlear implants/ ear implant
- Metallic fragments such as bullets, shotgun pellets, and metal shrapnel
- Cerebral artery aneurysm clips
- Ventriculo peritoneal shunt with metallic component generating significant artefacts on the MR sequence
- Catheters with metallic components (Swan-Ganz catheter)
- Patient unable to remain supine and motionless during the duration of the examination
- Participation in another interventional clinical trial of an investigational therapy within 30 days of consent
- No affiliation to a social security regime
- Vulnerable person according to article L1121-6 of the CSP
- Protected adult person
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hôpital National d'Instruction des Armées Percy
Clamart
Mathieu BOUTONNET
BOUTONNET Mathieu
- Recruiting
Beaujon Hospital
Clichy
Stéphanie SIGAUT
- Recruiting
Hôpital de la Pitié Salpêtrière - AP-HP
Paris
DEGOS Vincent
About this study
Traumatic brain injuries (TBI) are one of the leading causes of death and disability worldwide. These patients are burdened by physical, cognitive, and psychosocial deficits, leading to an important economic impact for society. Treatments for TBI patients are limited and none has been shown to provide prolonged and long-term neuroprotective or neurorestorative effects. TBI related disability is linked to the severity of the initial injury but also to the following neuroinflammatory response which may persist long after the initial injury.
Moreover, a growing body of evidence suggests a link between TBI-induced neuro-inflammation and neurodegenerative post traumatic disorders. Consequently, new therapies triggering immunomodulation and promoting neurological recovery are the subject of major research efforts.
Read more
In this context, mesenchymal cell-based therapies are currently investigated to treat various neurological disorders due to their ability to modulate neuroinflammation and to promote simultaneous neurogenesis, angiogenesis, and neuroprotection.
Clinical trials using intravenous MSC have been conducted for various pathologies, all these studies showing a good safety profile.
The hypothesis of the study is that intravenous repeated treatment with MSC derived from Wharton's Jelly of the umbilical cord may be associated with a significant decrease of post-TBI neuroinflammation and improvement of neuroclinical status.
The main objective of the study is to evaluate the effect of iterative IV injections of MSC on post-traumatic neuroinflammation measured in corpus callosum by PET-MRI at 6 months in severe brain injured patients unresponsive to simple verbal commands 5 days after sedation discontinuation.
Read the detailed description
Traumatic brain injuries (TBI) are one of the leading causes of death and disability worldwide. These patients are burdened by physical, cognitive, and psychosocial deficits, leading to an important economic impact for society. Treatments for TBI patients are limited and none has been shown to provide prolonged and long-term neuroprotective or neurorestorative effects. TBI related disability is linked to the severity of the initial injury but also to the following neuroinflammatory response which may persist long after the initial injury.
Moreover, a growing body of evidence suggests a link between TBI-induced neuro-inflammation and neurodegenerative post traumatic disorders. Consequently, new therapies triggering immunomodulation and promoting neurological recovery are the subject of major research efforts.
In this context, mesenchymal cell-based therapies are currently investigated to treat various neurological disorders due to their ability to modulate neuroinflammation and to promote simultaneous neurogenesis, angiogenesis, and neuroprotection. Indeed, several experimental studies have reported that human umbilical cord-derived mesenchymal stromal cells (MSC) have the ability to improve neurological outcomes and recovery in cerebral injury animal models, including TBI.
Clinical trials using intravenous MSC have been conducted for various pathologies, all these studies showing a good safety profile. In TBI, small clinical trials using different modalities for administration of mesenchymal cells are available but none about MSC derived from Wharton's Jelly of the umbilical cord.
The hypothesis of the study is that intravenous repeated treatment with MSC derived from Wharton's Jelly of the umbilical cord may be associated with a significant decrease of post-TBI neuroinflammation and improvement of neuroclinical status.
The main objective of the study is to evaluate the effect of iterative IV injections of MSC on post-traumatic neuroinflammation measured in corpus callosum by PET-MRI at 6 months in severe brain injured patients unresponsive to simple verbal commands 5 days after sedation discontinuation.
- Conditions
- Traumatic Brain Injury
- Being tested
- Mesenchymal Stromal Cells (MSC), placebo
- 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.
Mesenchymal Stromal Cells (MSC)Drug
3 injections one week apart
placeboDrug
3 injections one week apart
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Final product is a MSC solution at the concentration of 2.10^6/kg in 150 mL of NaCl 0.9% and human albumin 0.5%, conditioned aseptically and identified for IV administration.
3 injections one week apart. Receives: Drug: Mesenchymal Stromal Cells (MSC) |
| control | Placebo comparator | The placebo will be a solution of NaCl 0.9% 3 injections one week apart. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of iterative IV injections of WJ-UC-MSC on post-traumatic neuroinflammation
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in corpus callosum (Region of Interest, ROI) measured by dynamic PET-MRI
Measured: 6 months after the last injection
Secondary outcomes (27)
radiological markers from PET-MRI_1
The regional fractional anisotropy (FA) from DTI acquisition of PET-MRI
Measured: 6 months after the last injection
radiological markers from PET-MRI_2
The mean diffusibility (MD) from DTI acquisition of PET-MRI
Measured: 6 months after the last injection
Treatment feasibility
number of treatments administrated to the patient
Measured: at the third injection
Neurological clinical Score M6
Glasgow Outcome Scale-Extended
Measured: 6 months after the last injection
Neurological clinical Score M12
Glasgow Outcome Scale-Extended
Measured: 12 months after the last injection
cognitive assessment M6
MOCA scale
Measured: 6 months after the last injection
cognitive assessment M12
MOCA scale
Measured: 12 months after the last injection
short term Tolerance D10
Common Terminology Criteria for Adverse Events
Measured: 10 days after the last injection
long term Tolerance M6
Common Terminology Criteria for Adverse Events
Measured: 6 months after the last injection
long term Tolerance M12
Common Terminology Criteria for Adverse Events
Measured: 6 months after the last injection
neuroinflammation of pericontusional
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in pericontusional
Measured: 6 months after the last injection
neuroinflammation of grey matter
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in grey matter
Measured: 6 months after the last injection
neuroinflammation of white matter
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in white matter
Measured: 6 months after the last injection
neuroinflammation of frontal area
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in frontal area
Measured: 6 months after the last injection
neuroinflammation of parietal area
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in parietal area
Measured: 6 months after the last injection
neuroinflammation of occipital area
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in occipital area
Measured: 6 months after the last injection
neuroinflammation of hippocampus
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in hippocampus,
Measured: 6 months after the last injection
neuroinflammation of thalamus
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in thalamus,
Measured: 6 months after the last injection
neuroinflammation of mesencephalus
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in mesencephalus
Measured: 6 months after the last injection
neuroinflammation of cerebellum
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in cerebellum
Measured: 6 months after the last injection
Cytokine and chemokine levels in plasma
Luminex magnetic beads technology
Measured: 6 months after the last injection
PBMC profile
High-dimensional characterization of immune reprogramming during the treatment by single-cell RNA-sequencing of PBMC.
Measured: 6 months after the last injection
Transcriptomics and regulatory epigenomics of circulating monocytes and lymphocytes 1.
H3K27ac
Measured: 6 months after the last injection
Transcriptomics and regulatory epigenomics of circulating monocytes and lymphocytes 2.
H3K4me3
Measured: 6 months after the last injection
Transcriptomics and regulatory epigenomics of circulating monocytes and lymphocytes 3.
ChIP-seq
Measured: 6 months after the last injection
Transcriptomics and regulatory epigenomics of circulating monocytes and lymphocytes 4.
ATAC-seq
Measured: 6 months after the last injection
Genome-wide single-nucleotide polymorphism (SNP) genotype.
DNA sample
Measured: After 1 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start25 Jun 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent DEGOS, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146062
- Sponsor's protocol ID
- APHP211509
- Other IDs
- 2021-006873-50
- Acronym
- TRAUMACELL
- Status last verified
- Oct 2024
- First submitted
- 17 Nov 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sigaut S, Tardivon C, Jacquens A, Bottlaender M, Gervais P, Habert MO, Monsel A, Roquilly A, Boutonnet M, Galanaud D, Cras A, Boucher-Pillet H, Florence AM, Cavalier I, Menasche P, Degos V, Couffignal C. Effects of intravascular administration of mesenchymal stromal cells derived from Wharton's Jelly of the umbilical cord on systemic immunomodulation and neuroinflammation after traumatic brain injury (TRAUMACELL): study protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Dec 31;14(12):e091441. doi: 10.1136/bmjopen-2024-091441.
PubMed 39740941
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravascular Administration of Mesenchymal Stromal Cells Derived from Wharton's Jelly of the Umbilical Cord on Systemic Immunomodulation and Neuroinflammation After Traumatic Brain Injury.
- ClinicalTrials.gov ID
- NCT06146062
- Acronym / sponsor ID
- TRAUMACELL / APHP211509
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Nov 2023 (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.
Traumatic brain injuries (TBI) are one of the leading causes of death and disability worldwide. These patients are burdened by physical, cognitive, and psychosocial deficits, leading to an important economic impact for society. Treatments for TBI patients are limited and none has been shown to provide prolonged and long-term neuroprotective or neurorestorative effects. TBI related disability is linked to the severity of the initial injury but also to the following neuroinflammatory response which may persist long after the initial injury.
Moreover, a growing body of evidence suggests a link between TBI-induced neuro-inflammation and neurodegenerative post traumatic disorders. Consequently, new therapies triggering immunomodulation and promoting neurological recovery are the subject of major research efforts.
In this context, mesenchymal cell-based therapies are currently investigated to treat various neurological disorders due to their ability to modulate neuroinflammation and to promote simultaneous neurogenesis, angiogenesis, and neuroprotection.
Clinical trials using intravenous MSC have been conducted for various pathologies, all these studies showing a good safety profile.
The hypothesis of the study is that intravenous repeated treatment with MSC derived from Wharton's Jelly of the umbilical cord may be associated with a significant decrease of post-TBI neuroinflammation and improvement of neuroclinical status.
The main objective of the study is to evaluate the effect of iterative IV injections of MSC on post-traumatic neuroinflammation measured in corpus callosum by PET-MRI at 6 months in severe brain injured patients unresponsive to simple verbal commands 5 days after sedation discontinuation.
Detailed description
Traumatic brain injuries (TBI) are one of the leading causes of death and disability worldwide. These patients are burdened by physical, cognitive, and psychosocial deficits, leading to an important economic impact for society. Treatments for TBI patients are limited and none has been shown to provide prolonged and long-term neuroprotective or neurorestorative effects. TBI related disability is linked to the severity of the initial injury but also to the following neuroinflammatory response which may persist long after the initial injury.
Moreover, a growing body of evidence suggests a link between TBI-induced neuro-inflammation and neurodegenerative post traumatic disorders. Consequently, new therapies triggering immunomodulation and promoting neurological recovery are the subject of major research efforts.
In this context, mesenchymal cell-based therapies are currently investigated to treat various neurological disorders due to their ability to modulate neuroinflammation and to promote simultaneous neurogenesis, angiogenesis, and neuroprotection. Indeed, several experimental studies have reported that human umbilical cord-derived mesenchymal stromal cells (MSC) have the ability to improve neurological outcomes and recovery in cerebral injury animal models, including TBI.
Clinical trials using intravenous MSC have been conducted for various pathologies, all these studies showing a good safety profile. In TBI, small clinical trials using different modalities for administration of mesenchymal cells are available but none about MSC derived from Wharton's Jelly of the umbilical cord.
The hypothesis of the study is that intravenous repeated treatment with MSC derived from Wharton's Jelly of the umbilical cord may be associated with a significant decrease of post-TBI neuroinflammation and improvement of neuroclinical status.
The main objective of the study is to evaluate the effect of iterative IV injections of MSC on post-traumatic neuroinflammation measured in corpus callosum by PET-MRI at 6 months in severe brain injured patients unresponsive to simple verbal commands 5 days after sedation discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Mesenchymal Stromal Cells (MSC)Final product is a MSC solution at the concentration of 2.10^6/kg in 150 mL of NaCl 0.9% and human albumin 0.5%, conditioned aseptically and identified for IV administration. 3 injections one week apart. |
| control | Placebo comparator | Drug: placeboThe placebo will be a solution of NaCl 0.9% 3 injections one week apart. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-50 years
- ASA 1 classification (healthy patient)
Key exclusion criteria (52 listed)
- Lack of written consent
- Neurological history likely to alter the image (epilepsy, transient ischaemic attack, meningitis, head trauma)
- Vulnerable person according to article L1121-6 of the CSP
- Protected adult person
- No affiliation to a social security regime
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 |
|---|---|---|
| Mesenchymal Stromal Cells (MSC)3 injections one week apart | Drug | Intervention |
| placebo3 injections one week apart | Drug | control |
Primary outcome
effect of iterative IV injections of WJ-UC-MSC on post-traumatic neuroinflammation
Time frame: 6 months after the last injection
[18F]-DPA-714 Standard Uptake Value ratio (SUVr) in corpus callosum (Region of Interest, ROI) measured by dynamic PET-MRI
27 secondary outcomes
radiological markers from PET-MRI_1
Time frame: 6 months after the last injection
radiological markers from PET-MRI_2
Time frame: 6 months after the last injection
Treatment feasibility
Time frame: at the third injection
Neurological clinical Score M6
Time frame: 6 months after the last injection
Neurological clinical Score M12
Time frame: 12 months after the last injection
cognitive assessment M6
Time frame: 6 months after the last injection
cognitive assessment M12
Time frame: 12 months after the last injection
short term Tolerance D10
Time frame: 10 days after the last injection
long term Tolerance M6
Time frame: 6 months after the last injection
long term Tolerance M12
Time frame: 6 months after the last injection
neuroinflammation of pericontusional
Time frame: 6 months after the last injection
neuroinflammation of grey matter
Time frame: 6 months after the last injection
neuroinflammation of white matter
Time frame: 6 months after the last injection
neuroinflammation of frontal area
Time frame: 6 months after the last injection
neuroinflammation of parietal area
Time frame: 6 months after the last injection
neuroinflammation of occipital area
Time frame: 6 months after the last injection
neuroinflammation of hippocampus
Time frame: 6 months after the last injection
neuroinflammation of thalamus
Time frame: 6 months after the last injection
neuroinflammation of mesencephalus
Time frame: 6 months after the last injection
neuroinflammation of cerebellum
Time frame: 6 months after the last injection
Cytokine and chemokine levels in plasma
Time frame: 6 months after the last injection
PBMC profile
Time frame: 6 months after the last injection
Transcriptomics and regulatory epigenomics of circulating monocytes and lymphocytes 1.
Time frame: 6 months after the last injection
Transcriptomics and regulatory epigenomics of circulating monocytes and lymphocytes 2.
Time frame: 6 months after the last injection
Transcriptomics and regulatory epigenomics of circulating monocytes and lymphocytes 3.
Time frame: 6 months after the last injection
Transcriptomics and regulatory epigenomics of circulating monocytes and lymphocytes 4.
Time frame: 6 months after the last injection
Genome-wide single-nucleotide polymorphism (SNP) genotype.
Time frame: After 1 injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 39740941Sigaut S, Tardivon C, Jacquens A, Bottlaender M, Gervais P, Habert MO, Monsel A, Roquilly A, Boutonnet M, Galanaud D, Cras A, Boucher-Pillet H, Florence AM, Cavalier I, Menasche P, Degos V, Couffignal C. Effects of intravascular administration of mesenchymal stromal cells derived from Wharton's Jelly of the umbilical cord on systemic immunomodulation and neuroinflammation after traumatic brain injury (TRAUMACELL): study protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Dec 31;14(12):e091441. doi: 10.1136/bmjopen-2024-091441.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
Vincent DEGOS principal investigator
APHP
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal Stromal Cells (MSC) in people with Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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 2 inclusion and 52 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: looking for participants now, as of the sponsor's last update on 16 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 3 sites in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent Degos (142163761 ext. 33, vincent.degos@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of iterative IV injections of WJ-UC-MSC on post-traumatic neuroinflammation (time frame: 6 months after the last injection). 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 NCT06146062, which also lists 1 linked publication.
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 16 Oct 2024.