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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Mesenchymal Stromal Cells for Traumatic Brain Injury

MATRIx: MesenchymAl Stromal Cells for Traumatic bRain Injury

Mesenchymal Stromal Cells for Traumatic Brain Injury (NCT06163833) is a Phase 2 interventional studying Traumatic Brain Injury With Loss of Consciousness, sponsored by Fondazione IRCCS San Gerardo dei Tintori. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Traumatic Brain Injury (TBI) is an alteration of brain function caused by an external force. Long-term mortality in TBI is substantial, TBI survivors can develop chronic progressive disabilities and have a life expectancy shortened by 6 years. Treatment consists in supportive therapy directed at prevention of second insults, but no neuroprotective therapy is available. Given the multifaceted nature of TBI, mesenchymal stromal cells (MSCs) are an ideal candidate: they release multiple soluble factors shown to ameliorate the injury microenvironment through immunomodulatory, protective, reparative and regenerative processes. Preclinical data across a range of different TBI models and injury severities show that human MSCs improve outcome through pleiotropic mechanisms of protection and repair. Thus, data indicate MSCs as strong therapeutic candidate and support a clinical study in TBI. Aim: the study is designed to assess the safety and the efficacy of the MSCs, intravenously administered in severe TBI patients within 48h from injury. The study will be conducted in a stepwise manner. Step 1 will enroll 36 patients (randomized 1:1:1 in arms 80 x 10\^6 MSCs vs 160 x 10\^6 MSCs vs placebo) to define safety, and will allow to select the most promising dose. Step 2 will enroll 30 patients (1:1 in arms MSCs selected dose vs placebo) to define the MSC activity based on the quantification of the plasmatic levels of the neurofilament light (NFL) at 14 days, as biomarker of neuronal damage. Secondary objectives are aimed to assess: 1. brain injury evolution and white matter damage by longitudinal neuroimaging (at 4 days and 14 days post-TBI and at 6 months) 2. brain immunomodulatory changes by temporal profiling of circulating biomarkers of brain damage and neuroinflammation (daily for 3 days after TBI, at day 7 and 14, and at 1, 6 and 12 months) 3. clinical outcome by a structured clinical and neuropsychological assessment at both 6 and 12 months Methods: a multicenter, double blind, randomized, placebo-controlled, adaptive phase II dose finding study. Duration of the study: 36 months (24 of enrolment and 12 of follow up). Funding: Fondazione Regionale per la ricerca Biomedica, FRRB (Call "Unmet medical needs", proposal number 3440227) and Italian Ministry of health (Ministero della Salute, Bando di Ricerca Finalizzata 2021; proposal number RF-2021-12372642).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Traumatic Brain Injury With Loss of Consciousness 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 78 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 With Loss of Consciousness 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)

Who May Qualify: - Age: 18-70 years - Clinical frailty index (CFI) \< 5 - Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (Marshall's CT Classification \>1) - Feasibility of study drug (MSC/placebo) administration within 48 hours from TBI - GCS ≤ 8 at recruitment and at least one pupil reactive to light - ICP monitoring already inserted or planned for clinical indications - Weight \< 100 Kg and \> 40 kg Who Should NOT Join This Trial: - Motor GCS \> 5 at recruitment - High likelihood (\> 85%) of death in the first 48 h calculated by IMPACT calculator on early admission data - Bilateral mydriasis - Opening ICP \> 40 mmHg - Known history of prior brain injury, psychiatric disorder, neurological impairment and/or deficit - Brain penetrating injury - Spinal cord injury - Previous epilepsy requiring anti-convulsant therapy - Severe organ failure (including PaO2/FiO2\<200 and shock) - Recent serious infectious process - Cancer - Immunosuppression - Human weakened immune system virus - Positive urine pregnancy test or nursing - Known risk/history of coagulopathy and thromboembolism - Pre-existing and severe: - lung disease (such as asthma, chronic obstructive pulmonary disease), - heart dysfunction (as heart failure and reduced cardiac output), - liver insufficiency (as cirrhosis) - kidney insufficiency - and other organ severe abnormalities - Known hypersensitivity to excipients used in the formulation (Dimethyl sulfoxide (DMSO), Citrate-dextrose solution (ACD)) - Participation in a concurrent interventional study 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
Inclusion Criteria: * Age: 18-70 years * Clinical frailty index (CFI) \< 5 * Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (Marshall's CT Classification \>1) * Feasibility of study drug (MSC/placebo) administration within 48 hours from TBI * GCS ≤ 8 at recruitment and at least one pupil reactive to light * ICP monitoring already inserted or planned for clinical indications * Weight \< 100 Kg and \> 40 kg Exclusion Criteria: * Motor GCS \> 5 at recruitment * High likelihood (\> 85%) of death in the first 48 h calculated by IMPACT calculator on early admission data * Bilateral mydriasis * Opening ICP \> 40 mmHg * Known history of prior brain injury, psychiatric disorder, neurological impairment and/or deficit * Brain penetrating injury * Spinal cord injury * Previous epilepsy requiring anti-convulsant therapy * Severe organ failure (including PaO2/FiO2\<200 and shock) * Recent serious infectious process * Cancer * Immunosuppression * Human immunodeficiency virus * Positive urine pregnancy test or nursing * Known risk/history of coagulopathy and thromboembolism * Pre-existing and severe: * lung disease (such as asthma, chronic obstructive pulmonary disease), * heart dysfunction (as heart failure and reduced cardiac output), * liver insufficiency (as cirrhosis) * kidney insufficiency * and other organ severe abnormalities * Known hypersensitivity to excipients used in the formulation (Dimethyl sulfoxide (DMSO), Citrate-dextrose solution (ACD)) * Participation in a concurrent interventional study

Treatments Being Tested

DRUG

Mesenchymal stromal cell low dosage-80*10^6 cells

MSCs have to be administered at the dosage of 80\*10\^6. MSCs have to be administered by intravenous infusion via an in situ venous catheter within 15 minutes from the preparation and within 48 hours from TBI. They have to be diluted 1:2 in a saline solution for a total of 36mL.

DRUG

Mesenchymal stromal cell low dosage-160*10^6 cells

MSCs have to be administered at the dosage of 160\*10\^6. MSCs have to be administered by intravenous infusion via an in situ venous catheter within 15 minutes from the preparation and within 48 hours from TBI. They have to be diluted 1:2 in a saline solution for a total of 36mL.

OTHER

Placebo-storage solution

Placebo has to be administered by intravenous infusion via an in situ venous catheter within 15 minutes from the preparation and within 48 hours from TBI. It has to be diluted 1:2 in a saline solution for a total of 36mL.

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.

Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, Italy
ASST Ospedale Papa Giovanni XXIII Bergamo
Bergamo, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milano
Milan, Italy

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06163833), the sponsor (Fondazione IRCCS San Gerardo dei Tintori), 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 NCT06163833 clinical trial studying?

Traumatic Brain Injury (TBI) is an alteration of brain function caused by an external force. Long-term mortality in TBI is substantial, TBI survivors can develop chronic progressive disabilities and have a life expectancy shortened by 6 years. Treatment consists in supportive therapy directed at prevention of second insults, but no neuroprotective therapy is available. Given the multifaceted nature of TBI, mesenchymal stromal cells (MSCs) are an ideal candidate: they release multiple soluble factors shown to ameliorate the injury microenvironment through immunomodulatory, protective, reparativ… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06163833?

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 NCT06163833?

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 NCT06163833. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06163833. 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.