Medical applications · investigational
An investigational, patient-derived procedure for selected adults with pulmonary, cardiac, gastrointestinal, or neurological conditions where persistent inflammation, immune dysregulation, or impaired tissue repair are believed to contribute to ongoing symptoms.
This procedure is investigational. No stem cell or cellular therapy is FDA-approved for pulmonary, cardiac, gastrointestinal, or neurological diseases. Approaches described here are experimental and offered only after individual evaluation and informed consent. Read the full regulatory disclosure ↓
What it is
Boulder Biologics offers investigational autologous biologic procedures for selected patients with conditions where persistent inflammation, immune dysregulation, or impaired tissue repair are believed to contribute to ongoing symptoms.
No stem cell or cellular therapy is approved by the U.S. Food and Drug Administration (FDA) for the treatment of these conditions. The approaches described on this page are experimental, grounded in evolving translational and early clinical research, and offered only following comprehensive evaluation and informed consent.
Shared biology
Across diverse organ systems, many chronic conditions share overlapping biological mechanisms.
Chronic elevation of inflammatory cytokines, altered T-cell and NK-cell activity, and impaired immune resolution are common features in pulmonary, cardiac, gastrointestinal, and neurological disorders. Sustained immune activation is increasingly recognized as a driver of ongoing symptoms rather than a bystander process.
Refs. 1–3Rather than complete tissue destruction, many conditions involve dysfunctional repair signaling, endothelial injury, microvascular compromise, or abnormal extracellular matrix remodeling that limits recovery.
Refs. 1, 2In systemic disease states, peripheral inflammation can influence neural signaling, autonomic function, fatigue, and cognition. These mechanisms overlap with those described in post-viral and post-injury neurological conditions.
Refs. 1, 3Conditions under investigation
Each system has its own evidence base, and each is treated as investigational. Eligibility is decided case by case after evaluation.
Chronic inflammatory lung and cardiovascular conditions often involve endothelial dysfunction and immune dysregulation. MSC-associated signaling has been studied for its potential to support vascular integrity and modulate inflammation, though definitive clinical benefit remains unproven.
In inflammatory bowel disease (e.g., ulcerative colitis), immune dysregulation and epithelial barrier dysfunction are central pathophysiologic features. Reviews of MSC-based approaches describe potential immunomodulatory and reparative effects, while also highlighting ongoing challenges and inconsistent outcomes.
Refs. 3, 4Peripheral neuropathies and central nervous system disorders frequently involve neuroimmune interactions rather than isolated neuronal loss. MSC-associated biologics are being explored for their ability to modulate inflammatory signaling and support neurovascular function, rather than for direct neuronal replacement.
Refs. 1, 2If your condition isn't listed but involves chronic inflammation, immune dysregulation, or impaired tissue repair, the only honest answer is "let's evaluate." We'll review your records, tell you where the evidence stands, and either propose a path or refer you to a more appropriate one.
About the biology
Mesenchymal stromal cells (MSCs) are non-hematopoietic cells found in bone marrow and other tissues. In line with current scientific consensus and FDA-aligned language, their primary activity in the body is paracrine and immunomodulatory, rather than direct differentiation into mature organ-specific cells.
Claims that MSCs reliably transform into functional cardiomyocytes, neurons, hepatocytes, or other mature cells in humans are not supported by clinical evidence and are intentionally avoided.
WHAT TO EXPECT
This investigational approach is consistent with our CNS and Long COVID programs. No donor cells, no culture expansion, no genetic modification, no manufactured cellular products.
Full medical history, records review, and outside-cause workup. We'll tell you up front whether this is the right path or whether another clinic or trial fits better.
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 neurological contexts, intranasal delivery via olfactory / trigeminal pathways. Intranasal delivery remains investigational and is not FDA-approved for neurological disease.
Outcome-specific tracking with symptom instruments appropriate to the condition under treatment.
Safety considerations
Current evidence
Evidence for MSC-based biologics across these organ systems is preliminary and varies condition by condition, derived largely from laboratory work, small human studies, and reviews that also note inconsistent outcomes. This treatment is experimental supportive care, not disease-modifying therapy.
The strength of the evidence differs from one condition to the next. As a general matter:
Is this you?
Because the conditions here span multiple organ systems, eligibility is decided one case at a time after a full evaluation.
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 organ-specific cells in vivo. Any potential benefit is described as paracrine signaling, immune modulation, and support for endogenous repair.
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 marketed outside of approved clinical trials. At Boulder Biologics:
Participation is voluntary, and treatment is undertaken only after a comprehensive informed-consent process.
Intranasal delivery is explored as a potential route for biologic signaling molecules to access the central nervous system via the olfactory and trigeminal pathways. This route is investigational and not FDA-approved for the treatment of neurological disease.
References
Related
Schedule a medical-applications consultation
Dr. Glowney reviews your records, history, and current symptoms, and tells you honestly whether this investigational approach fits your case or whether another path makes more sense.
Or call 720-550-6175