Medical applications · investigational

Autologous biologic therapy and Long COVID.

Autologous bone marrow concentrate is an investigational, patient-derived biologic procedure for selected adults with persistent post-COVID symptoms. Delivered intravenously and, in selected cases, intranasally, BMAC may help alleviate symptoms of Long COVID.

Persistent fatigue Brain fog / cognitive symptoms Exercise intolerance Autonomic instability Post-viral inflammation

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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 investigational autologous biologic procedures for selected individuals experiencing persistent symptoms following SARS-CoV-2 infection, commonly referred to as Post-COVID Conditions or Long COVID. These procedures are intended to support recovery through immunomodulatory and reparative signaling mechanisms, rather than through direct tissue replacement.

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

Multiple Causes, but three common features.

Current evidence suggests Long COVID is a heterogeneous syndrome with several recurring biological features, rather than a single disease entity.

01 · Cardiopulmonary

Persistent organ dysfunction.

Lingering cardiopulmonary, vascular, or endothelial abnormalities following acute infection, which may manifest as:

Dyspnea or exercise intolerance
Palpitations or autonomic instability
Reduced diffusion capacity or imaging abnormalities

Ref. 1

02 · Immune

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

Refs. 1, 4–7

03 · Neurological

Neurological & cognitive dysfunction.

Recent neurobiological studies demonstrate:

Blood–brain barrier (BBB) disruption
Ongoing neuroinflammation
Altered glial and vascular signaling

Ref. 2

About the biology

Mesenchymal stromal cell (MSC)–containing biologics.

Mesenchymal stromal cells (MSCs) are non-hematopoietic cells found in bone marrow and other tissues. Importantly, current scientific consensus emphasizes that their clinical activity is primarily mediated by paracrine signaling and immune modulation, rather than by differentiation into organ-specific cells.

MechanismParacrine signaling · immune modulation

Property 1Immunomodulation of T cells, NK cells, macrophages

Property 2Anti-inflammatory signaling

Property 3Support of tissue repair environments

Property 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 have been observed in severe acute COVID-19 and are hypothesized to be relevant to post-acute immune dysregulation.

Refs. 4–7

Tissue repair signaling.

Rather than replacing damaged cells, MSC-derived paracrine factors may support endothelial repair, improve microvascular signaling, and promote a more permissive environment for endogenous tissue recovery.

Refs. 3, 4

Neurological considerations & intranasal delivery.

Preclinical and translational studies demonstrate that intranasal delivery of autologous cellular products can allow biologic signals to access the central nervous system via olfactory and trigeminal pathways, bypassing systemic circulation. This route is being investigated for neurological and cognitive symptoms, though it remains investigational. Ref. 8

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.

Pre-treatment

Step 02

Bone marrow aspiration

From the posterior superior iliac spine (PSIS) under local anesthesia and image guidance.

~30-60 min

Step 03

Filtration & minimal processing

Bone marrow aspirate is filtered and minimally processed in our on-site lab; cellular components may be concentrated.

~1-2 hrs

Step 04

Administration

Intravenous (IV) infusion and, in selected cases, intranasal atomization for CNS access via olfactory / trigeminal pathways.

Same-visit

Step 05

Follow-up

6 and 12 weeks; longer follow-up where indicated.

6 & 12 wks

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.
Despite only autologous materials being used, this approach is not 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. Early reports and small studies suggest possible improvement in fatigue, autonomic symptoms, and cognitive complaints. However:

Not all patients improve.
Controlled Long COVID–specific trials are still ongoing.
These therapies should be viewed as experimental supportive interventions, not established treatments.

Is this you?

A consultation is how we figure that out.

Eligibility is decided case by case. The list below is a starting point, not a checklist.

✓ Likely worth a conversation

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 paracrine signaling, immune modulation, and support for endogenous repair processes, consistent with the prevailing literature and FDA-accepted scientific framing.

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.

This page is intended to inform, not to promote unproven claims.

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;27:421–432.
Mesenchymal Stem Cell, Overview. ScienceDirect Topics.
Shi L, Wang L, Xu R, et al. Mesenchymal stem cell therapy for severe COVID-19. Signal Transduction and Targeted Therapy. 2021;6:339.
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, Wakao S, Hanibuchi M, et al. Mesenchymal stem cell immunomodulation in COVID-19–related cytokine storm. Stem Cells. 2021.
Beghini DG, Horita SI, Henriques-Pons A. Mesenchymal stem cells in the treatment of COVID-19. 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.

Where Long COVID fits in our medical applications work.

Schedule a Long COVID consultation

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.

Or call 720-550-6175