Autologous Biologic Therapy for Other Medical Conditions

Boulder Biologics offers investigational autologous biologic procedures for selected patients with pulmonary, cardiac, gastrointestinal, and neurological 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 Biological Features Across Chronic Medical Conditions

Across diverse organ systems, many chronic conditions share overlapping biological mechanisms, including:

1. Persistent Inflammation and Immune Dysregulation: 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. (1-3)

2. Impaired Tissue Repair Environments: Rather than complete tissue destruction, many conditions involve dysfunctional repair signaling, endothelial injury, microvascular compromise, or abnormal extracellular matrix remodeling that limits recovery. (1,2)

3. Neuroimmune and Neurovascular Involvement: In systemic disease states, peripheral inflammation can influence neural signaling, autonomic function, fatigue, and cognition. These mechanisms overlap with those described in post-viral syndromes and post-injury neurological conditions. (1,3)

About Mesenchymal Stromal Cell–Containing Autologous Biologics

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 in vivo activity is paracrine and immunomodulatory, rather than direct differentiation into mature organ-specific cells. (1,2)

Well-described properties include:

  • Modulation of innate and adaptive immune responses

  • Release of anti-inflammatory and trophic signaling molecules

  • Support of endothelial and stromal repair environments

  • Interaction with local tissue and immune 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.

Rationale for Autologous Biologic Use Across Organ Systems

Immune System Modulation: Preclinical and early clinical studies demonstrate that MSC-associated biologics can influence immune signaling by:

  • Reducing pro-inflammatory cytokines

  • Increasing anti-inflammatory mediators such as IL-10

  • Modulating T-cell and NK-cell activity

These effects are central to why MSC-containing biologics are being explored across inflammatory and immune-mediated diseases. (1-3)

Support of Tissue Repair Environments: Rather than replacing damaged cells, MSC-derived paracrine factors may:

  • Support endothelial and microvascular recovery

  • Improve stromal and extracellular matrix signaling

  • Create a biologic environment more permissive to endogenous repair

This framework is consistent across pulmonary, cardiac, gastrointestinal, and neurological research domains. (1,2)

Selected Clinical Contexts Under Investigation

Pulmonary and Cardiac Conditions: 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.

Gastrointestinal Conditions: 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. (3,4)

Neurological and Neuropathic Conditions: Peripheral 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. (1,2)

Autologous Bone Marrow–Derived Biologic Procedure (Investigational)

This investigational approach is consistent with your CNS and Long COVID programs and involves:

  1. Bone marrow aspiration from the posterior superior iliac spine (PSIS)

  2. Filtration and minimal processing of bone marrow aspirate

  3. Optional concentration of cellular components

  4. Autologous administration, which may include:

    • Intravenous (IV) delivery

    • Intranasal delivery in selected neurological contexts

No donor cells, culture expansion, genetic modification, or manufactured cellular products are used.

Intranasal Delivery: 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.

Safety Considerations

  • Autologous biologics reduce the immune rejection risks associated with donor-derived products

  • Published studies suggest acceptable short-term safety, but long-term efficacy is unknown (1-4)

  • Clinical response is variable, and some patients may experience no benefit

At Boulder Biologics:

  • Only autologous material is used

  • Patients are carefully screened

  • Therapy is presented as experimental supportive care, not curative treatment

FDA Regulatory Disclosure

  • No stem cell or cellular therapy is FDA-approved for pulmonary, cardiac, gastrointestinal, or neurological diseases

  • The procedures described are investigational

  • No claims are made regarding cure, organ regeneration, or disease modification

  • Outcomes vary; no benefit is guaranteed

This page aligns with FDA guidance on regenerative medicine marketing and avoids unsubstantiated claims.

References

1.     Mesenchymal Stem Cell – Overview. ScienceDirect Topics. https://www.sciencedirect.com/topics/engineering/mesenchymal-stem-cell

2.     Chen FH, Song L, Mauck RL, Li WJ, Tuan RS. Mesenchymal stem cells. In: Principles of Tissue Engineering. 3rd ed. Academic Press; 2007:823–843. doi:10.1016/B978-012370615-7/50059-7

3.     Hosseini-Asl SK, Mehrabani D, Karimi-Busheri F. Therapeutic effect of mesenchymal stem cells in ulcerative colitis: achievements and challenges. J Clin Med. 2020;9(12):3922. doi:10.3390/jcm9123922

4.     Guo G, Tan Z, Liu Y, et al. Therapeutic potential of stem cell-derived exosomes in ulcerative colitis and colorectal cancer. Stem Cell Res Ther. 2022;13:138. doi:10.1186/s13287-022-02811-5