ASFA Guidelines on Apheresis.

The American Society for Apheresis (ASFA) is the international medical society of reference in therapeutic apheresis, founded in 1981.

Since 1986 it has periodically published — currently every 3 years — the "Guidelines on the Use of Therapeutic Apheresis in Clinical Practice": a document classifying every published indication of therapeutic apheresis according to the quality and direction of available evidence.

The current edition is the Ninth Special Issue, published by Connelly-Smith et al. in Journal of Clinical Apheresis in 2023, and classifies more than 92 diseases. It is the guideline cited in hospital policies, insurer coverage decisions, regulatory evaluations, and clinical consensus statements worldwide.

ASFA classifies each indication into one of four evidence categories:

· Category I — apheresis accepted as first-line treatment, alone or in combination.
· Category II — accepted as second-line treatment.
· Category III — the optimal role is not established; the decision is individualized.
· Category IV — published evidence demonstrates or suggests that apheresis is ineffective or harmful; if applied, a research protocol is required.

The categories don't reflect efficacy alone — they reflect the totality of available evidence for that specific indication.

Separately from the category (I–IV), ASFA assigns each indication a recommendation grade based on an adaptation of the GRADE methodology.

· Number — strength of recommendation: 1 = strong, 2 = weak.
· Letter — quality of evidence: A = high (typically consistent randomized clinical trials), B = moderate, C = low (observational studies, case series).

For example, a 1A indication is a strong recommendation supported by high-quality evidence — the most solid clinical scenario. A 2C indication is a weak recommendation based on low-quality evidence — where individualized clinical judgment weighs more.

Classic Category I indications include:

· Thrombotic thrombocytopenic purpura (TTP) — the most solid indication, 1A evidence.
· Guillain-Barré syndrome moderate to severe (1A).
· Myasthenia gravis in crisis (1B).
· ANCA-positive rapidly progressive glomerulonephritis with acute renal failure (1A).
· Anti-glomerular basement membrane disease (Goodpasture) (1B).
· Humoral kidney transplant rejection (1B).
· CIDP — chronic inflammatory demyelinating polyneuropathy (1B).
· Neuromyelitis optica in acute attack (1B).

In these conditions, ASFA recognizes plasma exchange as standard first-line treatment supported by clinical trials.

No. ASFA classifies clinical indications where apheresis has been studied to treat a specific disease.

The application of plasma exchange as a longevity-medicine tool — biological age reduction, inflammaging modulation, PFAS or microplastic elimination — does not appear as an indication in ASFA because it is not a disease scenario classifiable under its methodology.

Evidence on TPE in longevity (Buck Institute study, Fuentealba et al., Aging Cell 2025) exists in indexed literature, but it remains outside the ASFA framework by design. This does not invalidate it — it places it in another context: clinical research and precision medicine, not approved disease treatment.

ASFA and regulators answer different questions.

ASFA asks: what does published clinical evidence say about using apheresis in this condition?

FDA, EMA, or INVIMA ask: is this device or procedure approved for this specific indication in my country?

An indication can be Category I in ASFA without the device being formally approved for it by the local regulator — and vice versa. ASFA orients evidence-based clinical practice; the regulator defines what can be commercialized and under what labeled indication. Serious clinical practice considers both.

ASFA updates its guidelines approximately every three years through a multidisciplinary writing committee made up of specialists in apheresis, hematology, neurology, nephrology, and transfusion medicine.

Each indication is systematically reviewed by at least two authors with bibliographic search updated to the editorial cutoff, application of adapted GRADE methodology, and committee consensus to assign the category and recommendation grade.

The Ninth Special Issue (2023) reviews more than 92 diseases. The tenth edition is anticipated around 2026.

The ASFA framework functions at Wellness Care as a clinical seriousness filter.

If a patient presents with a Category I or II indication — Guillain-Barré, myasthenia gravis, ANCA glomerulonephritis — that is the main conversation: TPE is solidly supported by the international guideline.

If the conversation involves a use outside ASFA — such as the application of TPE in longevity medicine — we say so explicitly: "this does not appear in ASFA; its support comes from independent, more recent literature (Buck Institute 2025, AMBAR 2020), and the decision is individualized under strict medical criteria".

The difference between a serious clinic and a marketing clinic is that the first one honestly names where each indication sits within the international evidence framework.