EV (extracellular vesicle) is a collective name for the small particles that cells release outside themselves. The "exosome" name or the particle count quoted in advertising does not, on its own, reveal the source, the donor background, or the quality documents. A physician explains the items whose source and quality records can be confirmed, separates clearly what is known from what is not yet known, and helps you organize things so you can decide by data rather than by a name. The lead times for iPS-derived EV and personal iPS-derived EV are confirmed within the same framework.
Entry point: a consultation on EV eligibility and quality (physician assessment) / fees presented individually at the physician consultation (self-pay care) / source, lot, and quality documents confirmed / shareable before your visit by LINE or email.
An exosome (EV) cannot be chosen by its name or research background alone. A physician confirms the source, the contents, and the quality documents one item at a time. Even if you do not have all the documents, you can begin a records consultation by LINE or WhatsApp with whatever you can send.
It is fine if you do not have all the documents. You can begin a records consultation by LINE or WhatsApp with whatever you can send.
We review source, particle count, purification process, sterility and so on in the documents. We do not judge a medical outcome from numbers or a name alone.
We confirm whose cells it comes from and whether it can be traced. Material of unknown origin, from multiple donors, or whose documents cannot be confirmed is not taken as a premise.
We explain it separately from care that is widely standardized in Japan. We treat it as a field still at the stage of research and practical development.
We separate what is known from what is not yet known. We do not assume an outcome.
Based on the documents, a physician organizes which options should be considered.
Even under the same labels—"exosome," "EV / extracellular vesicle"—which cell it came from, through which process, and as which lot it was made can differ greatly from one product to another. It is less widely known than you might expect, but easy-looking information such as a name or a particle count does not reveal the source, the donor background, the controls against contamination, or the checks performed before release.
That is exactly why we want to confirm the origin (source and donor), the quality records (lot, sterility, endotoxin, mycoplasma and so on), and the physician's explanation. EV / exosome material of unknown origin, from multiple donors, or for which quality records cannot be confirmed calls for particular caution. At our clinic, a physician explains the items whose origin and quality records can be confirmed, and we clearly separate what is still not known and keep it stated as not known.
This is not a claim that "EV is dangerous." It is a starting point for reading the records and your body's condition together, so that nothing is decided on a name alone. The items below are how we organize that.
With EV, "which cell did it come from" and "how was it confirmed" are checked not by the name alone but with documents.
See the research background and papers →
In academic terms, the small membrane particles that cells release outward are broadly called EV—extracellular vesicles. "Exosome" is a well-known word. In practice, however, vesicles and particles other than exosomes can be mixed in, and the way something was made or its source cannot always be stated with full certainty after the fact. So rather than putting the name front and center, our clinic values an explanation that confirms origin and quality records as an EV.
EV is the collective name for extracellular vesicles. It is used as a broad term covering particles of differing source and size, including exosomes and microvesicles.
Even when something is called an "exosome," the product and its records may include other vesicles, proteins, or medium components.
Particle count is a rough measure of quantity, but it does not stand in for source, purity, components, lot-to-lot variation, storage and transport, or the explanation to the body.
MSC-derived, iPS-derived, conditioned-medium-derived—an EV's meaning changes with "what it came from." When cells from multiple donors are used, we also confirm the donor background, the state of the cells, the culture conditions, and the approach to mixing and lot management. As long as the origin stays vague, what is being explained to the patient does not become clear either.
EV content can change with the environment the living cells were in, the culture conditions, the collection method, the purification method, and the storage conditions. Rather than judging quality or results by a high particle count alone, we look at the per-lot quality records, particle and protein information, residual cells, sterility, endotoxin, and mycoplasma.
EVs are small particles released by cells. The dots in the diagram are an image of particles; the name alone does not show the contents or the source.
We confirm whether that EV is from multiple donors, of unknown origin, or traceable as patient-derived / single-source.
Records of collection, purification, filtration, storage, and transport are confirmed separately from the product name.
Particle count, size distribution, sterility, endotoxin, mycoplasma, residual cells or fragments, and lot information are confirmed with documents.
These are review items before physician consultation, not proof of clinical effect.
EV / exosomes are very small particles. From appearance or name alone, you cannot tell what they were made from, which process they passed through, or as which lot they were shipped. Overseas, serious adverse events have been reported for material supplied as unapproved exosome products, and regulators have issued warnings. This is not a claim that "EV is dangerous." It is the point that without the origin, the way it is made, the steps that prevent contamination, the pre-release checks, and the physician's explanation, the patient finds it hard to judge.
Contamination means the mixing-in of microorganisms, components, cell fragments and the like that should not be there. That is exactly why we confirm sterility, endotoxin, mycoplasma, residual cells / fragments, and storage and transport conditions with quality records.
For MSC-derived or conditioned-medium-derived material, the explanation changes with whether it is single-donor or multiple-donor and with which cells were managed how. For multiple-donor material, confirming lot management, mixing conditions, and donor background is important.
Personal iPS-derived EV is explained as a flow that makes the material from the patient's own cells, so the confirmation points differ from a multiple-donor product. We confirm whose cells it came from, when it was made, and as which lot it was shipped.
The manufacturing and supplying company is responsible for product quality—manufacturing records, pre-release checks, lots, and storage and transport records. Even for a large company, a quality problem is a serious matter affecting continuity of supply and the trust of the whole organization. The clinic side is responsible for reviewing the documents, the physician's explanation, individual judgment, and follow-up.
Some EV-related products circulate as research reagents or raw materials. If you receive an explanation about use in the body, confirm whether it is a reagent, which documents are supplied to a medical institution, and the cost and the fact that it is unapproved.
Rather than asserting that contamination is "absolutely never present," we confirm with documents the steps taken to prevent it and how it was judged before release. To the patient, we separate which items can be explained as confirmed and what is still not known.
We confirm which cell it is derived from, whether single-donor or multiple-donor, and how the donor and cell background are managed.
What was extracted from the conditioned medium and what was removed. We look at this including things that can mix in, such as proteins and medium components.
We look at the items confirmed before release: sterility, endotoxin, mycoplasma, residual cells, and storage and transport conditions.
Particle count, protein amount, and size distribution are informative, but they are not the basis for judging quality or action on their own.
When several donors or cell lots are involved, whose cells they are, under which conditions they were cultured, and how lot-to-lot differences were managed become the center of the explanation.
Even when something is explained as patient-derived / single-source, risk is not eliminated. We confirm how far it can be traced—through collection, manufacture, storage, and pre-release checks.
Collection, purification, and filtration steps matter for reducing unwanted contamination. But beyond the step names, we confirm the pre-release judgment items with documents.
* For EV / exosomes, a physician organizes the product quality records, the route of supply, the unapproved area, the cost, the risks, the alternatives, and the consent explanation at the time of examination. Rather than deciding on your own, we confirm the records and your body's condition together.
Personal iPS-derived EV is a commissioned flow in which iPS cells are first created and stored from your own cells, and then the manufacture of iPS-derived EV is discussed. Rather than choosing by the name of an off-the-shelf product, we confirm the method of manufacture, the timeframe, the quality records, and the storage and release conditions, one by one.
As a guide, creating personal iPS takes roughly six months, and manufacturing iPS-derived EV takes roughly two additional months. When creating these from scratch, allow roughly eight months overall, with the specifics confirmed individually after your inquiry.
Detailed manufacturer information is confirmed with documents after your inquiry. On this public page, we organize the process, costs, required documents, and the points to check on how to use it, that a patient should understand before consultation.
We organize existing records and your wishes, and summarize the points to confirm before discussing personal iPS-derived EV.
A flow that creates and stores iPS cells from your own cells. The guide time is roughly six months.
Allow roughly two additional months for manufacturing iPS-derived EV, with quality records, storage, and release conditions confirmed.
Feasibility, cost, risks, and unconfirmed points are explained individually with the documents and the examination.
This flow is an arrangement to understand before consultation. The actual feasibility and content of the explanation are confirmed individually with the documents and the examination.
Even if you are interested in EV / exosomes, the first thing to look at is not the product name alone. We confirm, one by one and separately, the source, the manufacturer, the lot, the donor background, the particle count, the protein amount, the confirmation as a cell-free preparation, sterility, endotoxin, mycoplasma, the unapproved area, the cost, and the risks.
Product quality is confirmed with the maker's and supplier's documents, while medical judgment, explanation, and follow-up are the clinic's responsibility. This division of responsibility, too, is organized at the time of examination.
Having your imaging records, medical history, current treatment history, medications, and the symptoms that concern you ready makes it easier for the physician to organize the points to explain during the examination.
Imaging tests or blood results
Current treatment history and medications
Symptoms that concern you
The costs and risks you want to confirm
In a LINE or pre-examination consultation, we do not confirm a diagnosis or feasibility; we organize the information the physician needs for the explanation.
Organize the symptoms that concern you, your imaging records, medical history, current treatment history, medications, and the questions you want to ask—then we connect you to a physician consultation.
EV is the collective name for the small membrane particles that cells release outward, and an exosome is one part of that. Even when something is labeled "exosome," in practice other vesicles or medium components may be included. At our clinic, we value an explanation that confirms source and quality records as an EV, not by the name alone.
Not just the product name or particle count, but the quality records: source, donor background, lot, separation and purification process, sterility, endotoxin, mycoplasma, and storage and transport conditions. Material of unknown origin, from multiple donors, or for which quality records cannot be confirmed calls for particular caution; our clinic has a physician explain items whose origin and quality records can be confirmed.
Particle count can be a rough measure of quantity, but it does not stand in for source, purity, components, lot-to-lot variation, storage and transport, or the explanation to the body. A high particle count alone is not the basis for judging quality or results; a physician explains it together with the quality records.
The emphasis of the confirmation differs. For multiple-donor material, donor background, lot management, and mixing conditions become the center of the explanation. Even when something is explained as patient-derived / single-source, risk is not eliminated; we confirm with documents how far it can be traced—through collection, manufacture, storage, and pre-release checks.
No. We confirm your imaging records, medical history, current treatment history, medications, and the symptoms that concern you, and a physician organizes the product quality records, route of supply, unapproved area, cost, risks, alternatives, and consent explanation at the time of examination. Feasibility is judged individually by a physician.
For MSC, which is also discussed as a source of EV, we organize the confirmation points for quality and the provision framework.
We explain in detail the manufacturing process, timeframe, and confirmation items for iPS-derived EV that traces back to your own cells.
A consultation on autologous NK cell therapy under a Type 3 regenerative-medicine provision plan.
An overview of MSC, NK, and knee MSC eligibility review, in the order of tests, filing, and physician judgment.
We organize the approach to confirming the origin and quality records of cells and EVs before treatment.
We confirm particle count, size, cargo, the cardiac / joint / nasal routes, and CNS research, in each context.
Gather your imaging records, medical history, medications, and the symptoms that concern you, and we connect you to a physician consultation.
