Status:
RECRUITING
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.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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 e...
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 e...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06146062
Start Date
June 25 2024
End Date
March 31 2028
Last Update
October 16 2024
Active Locations (3)
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1
Hôpital National d'Instruction des Armées Percy
Clamart, France
2
Beaujon Hospital
Clichy, France
3
Hôpital de la Pitié Salpêtrière - AP-HP
Paris, France