Medical applications · investigational
An investigational, patient-derived procedure for selected adults with a history of traumatic brain injury and persistent post-traumatic symptoms, or symptom patterns consistent with chronic traumatic encephalopathy (CTE).
This procedure is investigational. No stem cell or cellular therapy is approved by the FDA for TBI, CTE, or post-traumatic neurodegeneration. CTE is a neuropathological diagnosis that cannot be definitively confirmed during life. Read the full regulatory disclosure ↓
What it is
Boulder Biologics offers investigational autologous biologic procedures for selected individuals with a history of traumatic brain injury (TBI) and persistent post-traumatic symptoms. These procedures are also explored in patients with symptom patterns consistent with chronic traumatic encephalopathy (CTE), recognizing that CTE is a neuropathological diagnosis that cannot be definitively confirmed during life.
The approaches described on this page are experimental, based on evolving scientific evidence, and offered only after a comprehensive informed-consent process, consistent with our approach to Long COVID and intranasal biologic therapies.
Shared biological features
As with Long COVID, chronic symptoms following TBI and repetitive head injury are increasingly understood to arise from secondary injury mechanisms, rather than from just the first mechanical insult alone.
Sustained activation of microglia, astrocytes, and peripheral immune signaling pathways contributes to ongoing neuronal stress and dysfunction long after the initial injury. This immune dysregulation parallels inflammatory mechanisms described in Long COVID-associated cognitive impairment.
Refs. 7, 8Disruption of the blood–brain barrier and cerebral microvasculature impairs nutrient delivery, waste clearance, and neurovascular coupling, mechanisms now recognized in both post-traumatic and post-infectious neurological syndromes.
Refs. 2, 5, 6In individuals with repetitive head impacts, chronic inflammation, axonal injury, and abnormal protein accumulation may drive progressive cognitive, behavioral, and motor symptoms over time.
Refs. 1, 7About the biology
Mesenchymal stromal cells (MSCs) are non-hematopoietic cells present in bone marrow and other tissues. Consistent with FDA-aligned scientific consensus, their primary within the body activity is paracrine and immunomodulatory, not direct neuronal differentiation or replacement of brain tissue.
As with our Long COVID program, we emphasize that any potential benefit arises from:
Claims of routine differentiation into functional brain cells are not supported in human clinical data and are intentionally avoided.
Rationale
Preclinical and early clinical studies suggest MSC-associated biologics may reduce pro-inflammatory cytokines and influence immune cell behavior after TBI, similar to mechanisms hypothesized in Long COVID.
Refs. 6–8
Animal models demonstrate increased expression of growth factors involved in angiogenesis and neurovascular support following administration of marrow-derived stromal cells. These effects are thought to improve the biologic environment for recovery, rather than replacing damaged neurons.
Refs. 5, 6
By influencing inflammation, apoptosis pathways, and microvascular integrity, MSC-associated signaling may help limit the secondary injury processes that contribute to chronic dysfunction and neurodegeneration. Refs. 1, 5, 6
WHAT TO EXPECT
This investigational approach mirrors the framework used in our Long COVID program. No donor cells, no culture expansion, no genetic modification, no manufactured cellular products.
Full medical history, imaging review, and case conference. Symptom timeline and prior care are reviewed before any procedure is scheduled.
From the posterior superior iliac spine (PSIS) under local anesthesia and image guidance.
Bone marrow aspirate is filtered and minimally processed in our on-site lab; cellular components may be concentrated.
Intravenous (IV) delivery and, in selected cases, intranasal delivery for CNS access via olfactory / trigeminal pathways. Intranasal delivery remains investigational.
Structured neurocognitive measures and symptom tracking over time.
Safety
Current evidence
Evidence for MSC-based biologics in TBI and suspected CTE is preliminary, derived largely from animal models, small human studies, and early-phase clinical investigations. This treatment is experimental, supportive, care - not disease-modifying therapy.
Reported improvements in some patients include memory and attention, cognitive endurance, neurofatigue, and autonomic symptoms. However:
Is this you?
Eligibility is decided case by case after a multi-visit workup that includes imaging review and, where relevant, a case conference.
WE WANT TO BE CLEAR
This page aligns with FDA guidance on regenerative medicine marketing and avoids unsubstantiated claims.
Consistent with FDA guidance and current scientific consensus, we avoid claims that mesenchymal stromal cells differentiate into functional brain cells in vivo. Any potential benefit is described as paracrine signaling, immune modulation, and support for endogenous repair, consistent with the prevailing literature.
References to "stem cells" on this page reflect cellular populations contained within autologous bone marrow–derived biologic material, not manufactured or expanded stem cell products.
The FDA has raised particular concern regarding allogeneic (donor-derived) stem cell products, including umbilical cord, placental, and amniotic products, marketed outside of approved clinical trials.
At Boulder Biologics:
Participation is voluntary, and treatment is undertaken only after a comprehensive informed-consent process.
As with Long COVID-associated cognitive dysfunction, intranasal delivery is explored as a route to allow biologic signaling molecules to access the central nervous system via olfactory and trigeminal pathways. Important alignment points:
References
Related
Schedule a TBI / CTE consultation
Our team will review your injury history, imaging, and current symptoms, and tell you honestly whether this investigational approach fits your case or whether another path makes more sense.
Or call 720-550-6175