NCT06146062 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.
| NCT ID | NCT06146062 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 68 participants in total. It began in 2024-06-25 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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-Ga
Frequently Asked Questions
Who can join the NCT06146062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06146062 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06146062 currently recruiting?
Yes, NCT06146062 is actively recruiting participants. Visit ClinicalTrials.gov or contact Assistance Publique - Hôpitaux de Paris to inquire about joining.
Where is the NCT06146062 trial being conducted?
This trial is being conducted at Clamart, France, Clichy, France, Paris, France.
Who is sponsoring the NCT06146062 clinical trial?
NCT06146062 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 68 participants.