Persistent organ dysfunction.
Lasting problems in the heart, lungs, or blood vessels after the infection, which can show up as:
- Dyspnea or exercise intolerance
- Palpitations or autonomic instability
- Reduced diffusion capacity or imaging abnormalities
Medical applications · investigational
Autologous biologic therapy and Long COVID.
Bone marrow concentrate (BMAC), made from your own bone marrow, is an investigational procedure we offer to selected adults with persistent post-COVID symptoms. It is given by IV and, in some cases, through the nose.
Persistent fatigue
Brain fog / cognitive symptoms
Exercise intolerance
Autonomic instability
Post-viral inflammation
This procedure is investigational. No stem cell or cellular therapy has been approved by the U.S. Food and Drug Administration for Long COVID or post-COVID conditions. Treatment is offered only after individual evaluation and informed consent. Read the full regulatory disclosure
What it is
A patient-derived approach to post-COVID conditions.
Boulder Biologics offers an investigational procedure, made from your own bone marrow, for selected adults who still have symptoms months after a COVID-19 infection (often called Long COVID). The idea being studied is that signals from these cells may calm an overactive immune response. The cells do not replace damaged tissue, and whether the procedure helps Long COVID is not yet known.
Post-COVID conditions remain an active area of scientific investigation. While no cellular therapy has been approved by the U.S. Food and Drug Administration (FDA) for Long COVID, emerging translational and early clinical literature support further study of autologous mesenchymal stromal cell–containing biologics in this context. See the selected literature
Biological features of post-COVID conditions
Several causes, three common features.
Current evidence suggests Long COVID is a heterogeneous syndrome with several recurring biological features, rather than a single disease entity.
Immune dysregulation & chronic inflammation.
Long COVID is frequently associated with:
- Persistent elevation of inflammatory cytokines (e.g., IL-6)
- Altered T-cell and NK-cell activity
- Features of immune exhaustion or autoinflammatory signaling
Neurological & cognitive dysfunction.
Recent neurobiological studies demonstrate:
- Blood–brain barrier (BBB) disruption
- Ongoing neuroinflammation
- Altered glial and vascular signaling
About the biology
Mesenchymal stromal cell (MSC)–containing biologics.
Mesenchymal stromal cells (MSCs) are cells found in bone marrow and other tissues that are not blood-forming cells. Researchers now think any effect they have comes mainly from the signals they release, which can adjust the immune system. They don't turn into new organ cells.
Proposed mechanismParacrine signaling · immune modulation
Studied effect 1Immunomodulation of T cells, NK cells, macrophages
Studied effect 2Anti-inflammatory signaling
Studied effect 3Support of tissue repair environments
Studied effect 4Endothelial & microvascular support
Rationale
Why investigators are studying MSC-containing biologics.
Immune system modulation.
Multiple experimental and early clinical studies suggest that MSC-containing biologics can down-regulate pro-inflammatory cytokines, increase anti-inflammatory mediators such as IL-10, and modulate overactive T-cell and NK-cell responses. These effects were seen in people with severe acute COVID-19, and researchers think they may be relevant to Long COVID. Most of these studies used donor or lab-grown MSCs, which differ from the same-day concentrate made from your own marrow that we use.
Refs. 4–7
Tissue repair signaling.
Signals released by MSCs may help repair the lining of blood vessels and support the body's own tissue recovery. They do not replace damaged cells.
Refs. 3, 4
Neurological considerations & intranasal delivery.
Animal studies suggest that cells given through the nose may reach the brain along the nerves for smell and facial sensation, without passing through the bloodstream first (ref. 8). We use this route for neurological and cognitive symptoms only as investigational care, and its effect in people with Long COVID is unknown.
What to expect
How the procedure works.
An investigational, in-clinic procedure. No donor cells, no genetic modification, no culture expansion.
Step 01
Consultation
Symptom timeline, longitudinal labs, imaging review, and outside-cause exclusion before any procedure.
Step 02
Bone marrow aspiration
From the posterior superior iliac spine (PSIS) under local anesthesia and image guidance.
Step 03
Filtration & minimal processing
Bone marrow aspirate is filtered and minimally processed in our on-site lab; cellular components may be concentrated.
Step 04
Administration
Intravenous (IV) infusion and, in selected cases, intranasal atomization for CNS access via olfactory / trigeminal pathways.
Step 05
Follow-up
6 and 12 weeks; longer follow-up where indicated.
Safety
What we tell patients about safety.
- Autologous biologics reduce the risks of immune rejection seen with donor-derived products.
- Published studies in COVID-19 populations report acceptable short-term safety profiles, though data remain limited.
- Using your own cells avoids the risk of rejection that comes with donor products. It does not make the procedure risk-free.
- Patients undergo careful screening.
Current evidence
Outcome expectations.
Clinical evidence for MSC-based biologics in Long COVID is preliminary and the treatment is investigational. However:
- Not all patients improve.
- Controlled Long COVID–specific trials are still ongoing.
Talking it through
A consultation is how we figure that out.
We work out together, case by case, whether this makes sense for you. The list below is a starting point.
What we look at together
- Persistent post-COVID symptoms ≥ 3 months after infection
- Documented infection history and symptom timeline
- Outside causes worked up and excluded
- Comfortable with a multi-visit workup pace and investigational framing
- Willing to engage in longitudinal follow-up and outcome tracking
- Realistic expectations: investigational supportive care, not a cure
WE WANT TO BE CLEAR
FDA Regulatory Disclosure.
The procedures described on this page involve autologous biologic products.
Regulatory status and FDA position
The U.S. Food and Drug Administration (FDA) has stated that no stem cell or cellular therapy has been approved to treat COVID-19, Long COVID, or post-COVID conditions. This includes therapies marketed for immune modulation, neurological recovery, fatigue, cardiopulmonary symptoms, or "regeneration."
The biologic procedures described on this page involve autologous human cells and tissues and are provided as investigational medical interventions, not as FDA-approved drugs or biologics. These procedures are offered based on physician judgment, emerging scientific evidence, and individualized patient evaluation.
The FDA has specifically cautioned patients and providers about clinics that:
- Claim stem cells can cure or reverse COVID-19 or Long COVID
- Claim injected cells replace damaged organs or brain tissue
- Market stem cells as "proven," "approved," or "guaranteed" treatments
Boulder Biologics does not make these claims.
Terminology and scientific accuracy
Consistent with FDA guidance and current scientific consensus:
- We avoid claims that mesenchymal stromal cells differentiate into functional lung, heart, or brain cells in vivo.
- We do not claim tissue regeneration, organ replacement, or cure of Long COVID.
- Any potential benefit is described as signaling, immune modulation, and support for the body's own repair processes, as in the published research.
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.
Autologous vs donor-derived cells
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:
- Only autologous (patient-derived) cellular material is used
- No donor cells are administered
- No culture expansion, genetic modification, or manufacturing of cells occurs
Investigational nature and informed consent
The FDA emphasizes that investigational cellular therapies must be presented transparently. Accordingly:
- Patients are informed that this approach is experimental.
- Clinical response is variable and unpredictable.
- Some patients may experience no benefit.
- Long-term efficacy data for Long COVID are not yet established.
Participation is voluntary, and treatment is undertaken only after a comprehensive informed-consent process.
Safety framing
While published studies in acute COVID-19 populations suggest that autologous and MSC-based cellular therapies have acceptable short-term safety profiles, the FDA cautions that:
- "Safe" does not mean "effective."
- Absence of short-term harm does not establish long-term benefit.
- Adverse events, including infection, thrombosis, immune effects, or lack of benefit, remain possible.
For this reason, safety is discussed conservatively, and no statements of "minimal risk" or "risk-free" therapy are made.
How this differs from non-compliant stem cell clinics
Boulder Biologics' approach differs from non-compliant stem cell marketing in that we:
- Do not advertise stem cells as FDA-approved.
- Do not claim disease modification, cure, or regeneration.
- Do not use donor-derived perinatal tissues.
- Do not imply endorsement by the FDA.
- Do not claim universal effectiveness.
FDA consumer guidance (for patient reference)
The FDA encourages patients considering cellular therapies to:
- Ask whether a treatment is FDA-approved
- Be skeptical of claims that sound "too good to be true"
- Understand the difference between clinical research and established therapy
Patients are encouraged to review FDA consumer resources on regenerative medicine and stem cell therapies.
References
Selected literature.
- Centers for Disease Control and Prevention. Post-COVID Conditions. cdc.gov.
- Greene C, Connolly R, Brennan D, et al. Blood–brain barrier disruption and sustained systemic inflammation in individuals with long COVID–associated cognitive impairment. Nature Neuroscience. 2024;27(3):421–432.
- Galipeau J, Sensébé L. Mesenchymal stromal cells: clinical challenges and therapeutic opportunities. Cell Stem Cell. 2018;22(6):824–833.
- Shi L, Wang L, Xu R, et al. Mesenchymal stem cell therapy for severe COVID-19. Signal Transduction and Targeted Therapy. 2021;6(1):339.
- Leng Z, Zhu R, Hou W, et al. Transplantation of ACE2- mesenchymal stem cells improves the outcome of patients with COVID-19 pneumonia. Aging and Disease. 2020;11(2):216–228.
- Song N, Wakimoto H, Rossignoli F, et al. Mesenchymal stem cell immunomodulation: in pursuit of controlling COVID-19 related cytokine storm. Stem Cells. 2021;39(6):707–722.
- Beghini DG, Horita SI, Henriques-Pons A. Mesenchymal stem cells in the treatment of COVID-19, a promising future. Cells. 2021;10(10):2588.
- Galeano C, Qiu Z, Mishra A, et al. The route by which intranasally delivered stem cells enter the central nervous system. Cell Transplantation. 2018;27(3):501–514.
- Phetsouphanh C, Darley DR, Wilson DB, et al. Immunological dysfunction persists for 8 months following initial mild-to-moderate SARS-CoV-2 infection. Nature Immunology. 2022;23(2):210–216.
- Klein J, Wood J, Jaycox JR, et al. Distinguishing features of long COVID identified through immune profiling. Nature. 2023;623(7985):139–148.
- Davis HE, McCorkell L, Vogel JM, Topol EJ. Long COVID: major findings, mechanisms and recommendations. Nature Reviews Microbiology. 2023;21(3):133–146.
Related
Where Long COVID fits in our medical applications work.
Schedule a call
Tell us about your case.
Dr. Glowney reviews your infection timeline, prior workup, and current symptoms, and tells you honestly whether this investigational approach fits your situation or whether another path makes more sense.
720-550-6175