DFPP

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Why I flew to Germany for a treatment that still isn’t FDA approved

I just finished two rounds of INUSpheresis in Dresden, Germany, a specialized form of double-filtration plasmapheresis (DFPP) that isn’t yet FDA approved in the U.S.

Some of you may be familiar with standard TPE / plasmapheresis, which removes your plasma and replaces it with donor albumin or plasma. By contrast, INUSpheresis is a double filtration process that separates your plasma, then runs it through a second, ultra-fine filter that removes autoantibodies, inflammatory proteins, and oxidized lipids, then returns your own cleaned plasma. No donor blood products needed, which in theory carries a lower infection/reaction risk than FDA-approved treatments like standard TPE / plasmapheresis and intravenous immunoglobulins (IVIG).

I had two treatments in Dresden. The first was with the INUS-30 filter, and the second was with the TKM58 filter. After the first session, I was wiped out for the rest of the day and most of the next day. Session two was more tolerable, and I definitely felt some weight lift off me when it was over.

The treatments were a success in terms of significantly lowering several biomarkers. However, I was told my longstanding 3+ year neurological and autonomic symptoms of orthostatic tachycardia (elevated heart rate), brain fog, PEM, and heat sensitivity will still be present for a short while — but so far, the “brain on fire” sensation has somewhat improved. Rather than an instant difference, my treating apheresis doctors told me to expect significant improvements within 3-4 weeks, as my body’s microvasculature needs to gradually adjust to the sudden removal of autoantibodies and toxins that were distressing the vessel wall linings for the last 3 years and 4 months.

Aside from its medical uses, the INUSpheresis treatment’s TKM58 filter is very effective at removing environmental toxins, PFAS, and heavy metals. This may explain why I suddenly felt lighter after the second treatment.

My lab results after treatment speak for themselves and are really impressive. The medical team at the apheresis unit in Dresden took pre- and post-treatment labs for each session. They also sent out CellTrend autoantibody labs, with results still pending. Comparing my labs before treatment #1 to after treatment #2:

• Total cholesterol: lowered 60.0%
• LDL cholesterol: lowered 62.0%
• Lipoprotein(a): lowered 79.5%
• Fibrinogen: lowered 63.3%
• IgG: lowered 50.5%
• IgM: lowered 73.2%
• IgA: lowered 62.4%

Fibrinogen and Lp(a) are important because they correlate with blood viscosity, red cell clumping, and potential microclots. Lowering fibrinogen sharply, even temporarily, is thought to immediately improve blood flow through the smallest vessels. Immunoglobulins (IgG, IgM, IgA) carry the body’s antibody arsenal, including potentially the autoantibodies implicated in a range of autoimmune and post-viral conditions. Reducing immunoglobulins has been shown to reduce autoantibodies in circulation. However, the reduction isn’t permanent, since apheresis only removes circulating autoantibodies, not the plasma cells that keep making them, so IgG and IgM levels naturally rebuild over the following weeks. For people with medical conditions, the purpose of the treatment is to create a temporary low-autoantibody window to prevent GPCRs from being targeted — the receptors that regulate heart rate, blood vessel constriction, and autonomic functions. During that window, the blood vessel lining and autonomic nerve pathways get a chance to recover from the sustained dysregulation the autoantibodies were causing.

My treating apheresis doctors in Dresden, Dr. Bornstein and Dr. Tselmin, are absolutely world-class and were co-authors on the May 2023 study in Molecular Psychiatry (Achleitner et al., doi:10.1038/s41380-023-02084-1) that followed 27 post-COVID patients through this exact protocol and found significant drops in autoantibodies, lipids, and inflammatory markers (CRP, IL-6, IL-1β) that tracked with patient-reported improvement. When I asked them about a larger follow-up trial, they said one is planned eventually, but there are no larger controlled studies yet.

Many people have been treated with INUSpheresis for longevity and environmental detoxification across Germany, Austria, Switzerland, Cyprus, and Japan. However, it’s cash-pay for these purposes, including for post-COVID symptoms. Even in Germany, only standard TPE / plasmapheresis and lipoprotein apheresis are covered by insurance, and only for established conditions like Guillain-Barré syndrome, myasthenia gravis, or severe lipid disorders. INUSpheresis is cash-pay across the board, and most protocols call for at least two sessions, so it can get pricey.

It isn’t yet FDA-approved in the U.S., and no one seems to know when that will change. I am in the process of writing to members of Congress, the NIH, the FDA, and health advocacy groups, requesting fast-track FDA approval for INUSpheresis / DFPP and compassionate-use pathways for non-approved apheresis treatments. INUSpheresis has proven effective for longevity, detoxification, and serious medical conditions for people across Europe, yet it remains completely out of reach for the vast majority of Americans dealing with similar conditions.

I will be closely tracking my symptoms and posting another update in a few weeks from now, based on my treating physicians’ guidance that it can take a few weeks to notice significant improvements.

As I await symptomatic improvements, I will be advocating at the doors of Congress and our health institutions on behalf of myself and the millions of Americans who need effective solutions, especially those that are already proving to work for patients overseas.


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