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.
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT06146062
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 68
- Starts
- 2024-06-25
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2024-10-16
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 18-50 years
- ASA 1 classification (healthy patient)
You may not qualify if…
- 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)
Where it is running
- Hôpital National d'Instruction des Armées Percy — Clamart, France (enrolling)
- Beaujon Hospital — Clichy, France (enrolling)
- Hôpital de la Pitié Salpêtrière - AP-HP — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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