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.

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. (NCT06146062) is a Phase 2 interventional studying Traumatic Brain Injury, sponsored by Assistance Publique - Hôpitaux de Paris. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Traumatic Brain Injury and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 68 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Traumatic Brain Injury subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Mesenchymal Stromal Cells (MSC)

3 injections one week apart

DRUG

placebo

3 injections one week apart

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hôpital National d'Instruction des Armées Percy

Clamart, France

Beaujon Hospital

Clichy, France

Hôpital de la Pitié Salpêtrière - AP-HP

Paris, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06146062), the sponsor (Assistance Publique - Hôpitaux de Paris), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06146062 clinical trial studying?

Who can participate in NCT06146062?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06146062?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06146062. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06146062. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.