Informations générales (source: ClinicalTrials.gov)
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.
Interventional
Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2024
mars 2028
12 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HIA PERCY | DEGOS Vincent | 13/12/2025 07:35:49 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:35:49 | Contacter | |||
| AP-HP - Hôpital Beaujon | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital de la Pitié Salpêtrière - AP-HP - Paris - France | DEGOS Vincent | Contact (sur clinicalTrials) | |||
| Hôpital National d'Instruction des Armées Percy - Clamart - France | Mathieu BOUTONNET | Contact (sur clinicalTrials) | |||
Critères
Tous
20 healthy volunteers will be included for MRI normalization Volunteer eligibility
criteria
Inclusion criteria :
- Age 18-50 years
- ASA 1 classification (healthy patient)
Exclusion criteria :
- 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
- 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
criteria
Inclusion criteria :
- Age 18-50 years
- ASA 1 classification (healthy patient)
Exclusion criteria :
- 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
- 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