Secretome vs Exosome IV Therapy: Safety and How to Choose

Key takeaways

• Cell therapy uses living cells, stem cell secretome uses everything the cells release together with the fluid, and exosome products concentrate and purify the tiny particles within it
• Quality varies widely with the manufacturing process, so the name on the label tells you little about the contents
• In Japan, cell-free secretome and exosomes generally fall outside the law that governs cell therapies, so oversight works differently
• Searches for risks and deaths reflect real concern about safety, which makes checking the manufacturer, test records and physician set-up essential
• Sessions are often discussed as a short series spaced days to weeks apart, but the physician decides, and a three-session set at our Barcelona partner clinic costs 1,000 to 1,500 euros excluding VAT

Part 1: Stem cell vs secretome vs exosome

The names sound alike, yet what goes into the body differs greatly. Many people asking what exosome therapy is want to know how it differs from secretome, so let us separate the three.

1. Cell therapy (living stem cells)

Stem cells are taken from fat, bone marrow or other tissue, cultured, and returned to the body as living cells. The cells are expected to act inside the body, but processing and quality control must meet high standards, and in Japan this is subject to review under a dedicated law.

2. Stem cell secretome

The secretome is the culture fluid with the cells removed. It contains the many substances the cells released, including cytokines, growth factors and exosomes. There are no living cells, and the idea is to use the full combination of components.

3. Exosome products (purified particles)

Exosomes are tiny vesicles roughly tens to a little over a hundred nanometres across. They carry proteins and microRNAs and are thought to play a role in communication between cells. Exosome IV therapy generally means isolating these particles from the secretome by centrifugation or filtration, concentrating them and giving them into a vein.

Seeing the three side by side

In short, cell therapy uses the cells themselves, secretome uses the whole mixture the cells release, and an exosome product collects one particular type of particle from that mixture. The two cell-free options are thought to carry fewer cell-specific concerns, such as unexpected cell growth, but as medical products they face equally strict questions about sterility and impurities.

Why quality differs between products

For both secretome and exosome products, the contents depend on the cell source (fat, umbilical cord, dental pulp and so on), the donor, the culture medium, the length of culture, the purification method and the storage temperature. There is no common way to express exosome quantity, so products cannot be compared on numbers alone. It is safest to assume that two products both labelled exosome are not the same.

Part 2: What can be said about exosome benefits

Because exosomes carry signals between cells, their possible role in regulating inflammation and supporting tissue repair is being studied, and cell and animal studies have reported interesting results. Some argue that concentrating the particles may allow a more targeted action. Exosome IV therapy is also often offered for aesthetic or general wellbeing purposes, and clinics explain it in different ways.

Clinical research in humans remains limited, however, and there is no solid evidence that either secretome or exosome products are superior to the other. Neither is an approved treatment for any specific disease, and both remain at the research stage. Individual responses vary, and no particular outcome can be guaranteed.

Even when advertising or personal stories emphasise benefits, it helps to ask whether the evidence comes from cell studies, animal studies or clinical research in humans. The size of a study and whether it included a comparison group are also useful clues to how reliable the information is.

Part 3: Why people search for risks and deaths

Search suggestions that pair exosome IV therapy or stem cell secretome with words such as danger or death show that many people are worried about safety and are looking for information. This article cannot verify individual reports or establish cause and effect, but knowing the risks that are generally pointed out is important.

• Infection from products contaminated during manufacture or storage
• Severe allergic reactions (anaphylaxis)
• Use of products whose manufacturer or test records are unclear
• Administration in settings without a physician or equipment to handle emergencies

Any procedure given directly into a vein carries some risk, whatever the product, which is why both the product and how it is delivered need checking.

Warning signs after a session

Temporary tiredness or a low fever is sometimes reported, but if you experience breathing difficulty, widespread hives, a high fever, or pain and swelling that do not settle, tell the medical staff immediately or seek medical care. After returning home, see a doctor near you first.

Part 4: How regulation differs in Japan and Spain

In Japan, regenerative medicine using processed cells is governed by the Act on the Safety of Regenerative Medicine, which requires providers to submit plans for committee review. Cell-free secretome and exosomes, by contrast, have generally been interpreted as falling outside this law and are offered as self-funded care at the physician's discretion. As a result, much of the responsibility for checking manufacturing and quality rests with each clinic. The rules may be revised, so please check official sources for the latest position.

In the EU and Spain, medical procedures are expected to be performed by licensed physicians in facilities authorised by the health authorities, and treatments at the partner clinic are carried out following a physician's examination and judgement. Different rules in different countries do not mean safety is guaranteed anywhere, though. Wherever you go, we recommend working through the checklist below.

Part 5: A checklist for choosing a provider safely

• Who manufactures the product, and can the clinic name the facility and its country
• Can you see the lot number and the certificate of analysis
• Are sterility and endotoxin test results available
• Is temperature control documented from manufacture to administration (cold chain)
• Does a physician examine you and review your history and medication beforehand
• Are drugs, equipment and procedures ready for emergencies such as anaphylaxis
• Is there written informed consent after the risks and uncertainties are explained
• Is the price broken down in advance, with clear conditions for any extra charges

If any answer is vague, take time to ask more questions or consider other options rather than deciding on the spot. Asking your own doctor for an opinion is another good step. During the pre-consultation stage, we help you ask about the manufacturer and test records, with an interpreter present.

Part 6: How often sessions are given

How often to have exosome therapy is another common question. Rather than a single session, a short series spaced days to weeks apart is often suggested, but there is no standard yet for the best number of sessions or intervals.

More sessions are not necessarily better. The physician decides based on your condition, medical history, goals and length of stay, and for the three-session set at the partner clinic the physician sets the intervals to fit your stay. Keeping simple notes on sleep, meals and how you feel between sessions gives you useful material for discussions with the physician.

Part 7: Comparing exosome therapy prices

In Japan, secretome and exosome IV sessions are self-funded, and prices vary widely, from tens of thousands of yen to several hundred thousand yen per session. Product, concentration and clinic all make a large difference, so simple comparisons are difficult.

At our Barcelona partner, NB Science Stem Cell Clinic (surgeon Dr. A. Sergio), a three-session set of stem cell secretome IV or injection is indicatively 1,000 to 1,500 euros (about 184,000 to 276,000 yen). This excludes 21% VAT. Including VAT, it comes to about 1,210 to 1,815 euros (roughly 220,000 to 330,000 yen). Yen figures use 1 euro to 184 yen.

Travel adds flights and accommodation. Rather than judging on price alone, compare what is included, such as the examination, testing, interpretation and follow-up at home. The actual content and price are set after the physician's examination. For those who want to check their current condition first, the partner clinic also offers personal testing (blood, SNP and urine, 2,000 euros) and a same-day genetic test (600 euros), and whether to add testing can be discussed with the physician.

Summary

Cell therapy, stem cell secretome and exosome products have similar names, but what goes into the body is different. All of them remain at the research stage, and safety depends heavily on product quality and the physician's set-up, so the basics of choosing are to look beyond names and prices to the manufacturer, the test records, the examination and the emergency preparations.

Medical Bridge coordinates a free online pre-consultation with the partner clinic, where you can ask about product information and test records with an interpreter present and then decide for yourself whether to go ahead.

Photos: Zcsharp / CC BY 4.0 · René Volfík, FZU / CC BY-SA 4.0 (Wikimedia Commons)