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. - Trial NCT06146062
Access comprehensive clinical trial information for NCT06146062 through Pure Global AI's free database. This Phase 2 trial is sponsored by Assistance Publique - Hôpitaux de Paris and is currently Not yet recruiting. The study focuses on Traumatic Brain Injury. Target enrollment is 68 participants.
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Study Focus
Sponsor & Location
Assistance Publique - Hôpitaux de Paris
Timeline & Enrollment
Phase 2
Jan 02, 2024
Jun 30, 2027
Primary Outcome
effect of iterative IV injections of WJ-UC-MSC on post-traumatic neuroinflammation
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. 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06146062
Non-Device Trial