Cord Tissue Stem Cells Enter a Trial for CTE – the Brain Injury Linked to Repeated Head Knocks

Key details

• A first-of-its-kind trial: A US biotech, TriCelX, has taken a stem cell therapy into an early-stage clinical trial for chronic traumatic encephalopathy (CTE) - the progressive brain condition caused by repeated knocks to the head. There has never been an approved treatment for it.[1][2]
• Cord tissue stem cells: The therapy, called XytriX, is made from mesenchymal stem cells (MSCs) taken from donated umbilical cord tissue -the very same type of cell families set aside when they store their baby’s cord tissue.[2][3]
• Aimed at athletes and veterans: CTE has been found in former footballers, boxers and military personnel exposed to blast injury. This trial is designed for adults living with confirmed or probable CTE.[2]
• Early days: This is a small Phase 1/2 safety study, not an approved treatment – but it is a notable step for cord tissue stem cells in brain medicine.

A trial for a condition with no treatment

Chronic traumatic encephalopathy, or CTE, is a brain disease linked to repeated head impacts over many years. It has been found in the brains of former American football players, boxers and other contact-sport athletes, as well as in military personnel exposed to blast injury. It tends to develop slowly, affecting memory, mood and thinking, and at present it can only be confirmed with certainty after death. Until now, doctors have had nothing to offer beyond managing the symptoms.[2]

That is the gap a Texas-based company, TriCelX, is hoping to address. In May 2026 it filed a Phase 1/2 application with the US Food and Drug Administration to begin testing its stem cell therapy, XytriX, in adults with CTE, and specialist pharmaceutical press reported in June that the regulator had authorised the trial to proceed.[1][2] It is described as the first treatment of its kind to reach this stage for CTE.

What is being tested?

XytriX is an “off-the-shelf” cell therapy made from mesenchymal stem cells (MSCs) found in Wharton’s jelly - the soft, cushioning tissue inside a donated umbilical cord. Unlike some cell therapies that require patient-specific cell collection or matching, XytriX is designed as an off-the-shelf, donor-derived product that does not require HLA matching.[2][3]

The study is a Phase 1/2, open-label, dose-escalation trial enrolling approximately 24 adults, with an optional expansion to around 36 participants, all with confirmed or probable CTE. Participants receive the cells over three treatment cycles and are followed for two years, with cognitive outcomes assessed using standardised neuropsychological tests including the Neuropsychological Assessment Battery – a set of tests that evaluate cognitive, executive, and sensory/motor function. It is running at a single site, the Baylor Scott & White Sports Therapy & Research Center in Frisco, Texas.[2]

How could stem cells help the brain?

Mesenchymal stem cells are not expected to simply replace damaged brain cells. Their value also lies in what they release - a mixture of signalling molecules that could reduce inflammation, support surviving cells and encourage the body’s own repair processes. The company reports that the cells travel towards damaged areas and release protective factors.[2]

This builds on earlier work using MSCs in traumatic brain injury, where studies have suggested the approach is reasonably safe and may bring some benefit. In December 2024, the US Food and Drug Administration (FDA) approved Ryoncil®, the first FDA-approved allogeneic MSC product, establishing a regulatory and safety benchmark for the class.[4]

What this means for parents who store cord tissue

The therapy being trialled is built from mesenchymal stem cells from umbilical cord tissue - the same cells preserved when you bank cord tissue with Cells4Life.

Cord tissue is one of the richest sources of these cells, and they feature in a growing number of regenerative-medicine studies worldwide, from joint and tissue repair to inflammation and, now, conditions affecting the brain.[5][6][7] The cells in this trial come from donors, and the therapy is a US research programme. While still in the trial phase, it’s a first step towards potential future therapies for conditions such as CTE. The trial also highlights how seriously cord tissue stem cells are being explored in efforts to address some of medicine’s challenging conditions.

To learn more about the regenerative potential of cord blood and cord tissue stem cells, and how to store your baby’s at birth, request your free Cells4Life Welcome Pack.

References

[1] FirstWord Pharma. “FDA Clears First-in-Indication Cell Therapy Trial for Chronic Traumatic Encephalopathy.” 15 June 2026. https://firstwordpharma.com/story/7593626

[2] TriCelX, Inc. “TriCelX Files FDA IND for XytriX™ in Chronic Traumatic Encephalopathy (CTE).” 18 May 2026 (via The National Law Review / EIN Presswire). https://natlawreview.com/press-releases/tricelx-files-fda-ind-xytrixtm-chronic-traumatic-encephalopathy-cte

[3] TriCelX, Inc. “TriCelX Receives FDA Study May Proceed Letter for XytriX™” (knee osteoarthritis programme; describes the cord-tissue MSC product). 23 April 2026. https://natlawreview.com/press-releases/tricelx-receives-fda-study-may-proceed-letter-xytrixtm

[4] U.S. Food and Drug Administration. FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease. 18 December 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host

[5] Lanzoni, G., et al. (2021). Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: a double-blind, phase 1/2a, randomized controlled trial. Stem Cells Translational Medicine, 10(5), 660-673. https://doi.org/10.1002/sctm.20-0472

[6] Comparative Analysis of Human Mesenchymal Stem Cells from Bone Marrow, Adipose Tissue, and Umbilical Cord Blood as Sources of Cell Therapy (2013). International Journal of Molecular Sciences, 14(9), 17986-18001. https://www.mdpi.com/1422-0067/14/9/17986

[7] Raposo, L., Lourenço, A. P., Nascimento, D. S., Cerqueira, R., Cardim, N., & Leite-Moreira, A. (2021). Human umbilical cord tissue-derived mesenchymal stromal cells as adjuvant therapy for myocardial infarction: a review of current evidence focusing on pre-clinical large animal models and early human trials. Cytotherapy, 23(11), 974–979. https://doi.org/10.1016/j.jcyt.2021.05.002