Chief MD, Gangnam
Duk-ha Kim
The trust our patients have placed in this clinic was built on conviction and principle. We intend to hold to both, unchanged, through the next hundred years.
Seoul
Regulatory status and evidence guide
One menu word can cover very different materials — cells separated from fat, a preparation made from blood, a culture supernatant, or an exosome product — and those materials are not in the same regulatory category and do not rest on the same evidence. This page sets out what is documented in the United States, how Korea’s separate advanced regenerative medicine route is described, how early the published evidence still is, and what has been reported as harm, so that the material being offered can be identified and asked about rather than assumed.
No, and that distinction is what everything else here depends on. Cells are cells — for example the cell-containing fraction separated from fat tissue, which FDA names as stromal vascular fraction, fat-derived cells, in its patient and consumer information on regenerative medicine therapies. Exosomes are not cells: they are vesicles released by cells, and FDA states that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products. A culture supernatant — the fluid in which cells were grown — is a third thing again, and what it contains depends entirely on how it was produced and what was done to it afterwards. Promotional language collapses all of this into one word. Regulation does not, and neither does the published literature, which studies these categories separately. Asking which of them is being used is therefore not a technicality: the answer decides which rules apply and which evidence, if any, is even relevant to the conversation.
Sources: FDA — important patient and consumer information about regenerative medicine therapiesFDA — public safety notification on exosome products (2019-12-06)FDA consumer alert — regenerative medicine products including stem cells and exosomes
A narrow list, and FDA states it plainly: the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells, also known as hematopoietic progenitor cells, that are derived from umbilical cord blood. The same consumer alert states that there are currently no FDA-approved exosome products. Two limits govern how far those sentences can be carried. First, the alert does not address cosmetic or aesthetic use anywhere in it, so it makes no statement in either direction about skin menus. Second, FDA also tells consumers that if you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally — and that is FDA describing the market it regulates, which is the United States. It is not a statement about Korean law, about Korean clinics, or about any procedure performed outside the US, and repeating it as though it were would misstate both systems.
Sources: FDA consumer alert — regenerative medicine products including stem cells and exosomesFDA — important patient and consumer information about regenerative medicine therapies
Two tests, and both have to be met for the lighter category to apply. FDA’s guidance on human cells, tissues, and cellular and tissue-based products sets them out at 21 CFR 1271.10(a): the product must be minimally manipulated, meaning the processing does not alter the relevant characteristics of the tissue or the relevant biological characteristics of the cells, and it must be intended for homologous use, meaning it performs the same basic function in the recipient that it performed in the donor. Meet both and the product is regulated as a 361 HCT/P without premarket review. Fail either and it is a drug or biological product, which in the US means an investigational new drug application to study it and a biologics licence application to market it. That is why a question such as whether cells are expanded in a laboratory before use, or what function the material is said to perform in the place it is put, is a regulatory question rather than a technical aside. One scope note belongs with it: this framework governs the United States and settles nothing about Korea.
Sources: FDA guidance — HCT/Ps: minimal manipulation and homologous use
Korea operates its own system, presented through a national portal for advanced regenerative medicine. As described there, advanced regenerative medicine is carried out at designated regenerative medicine institutions, under research or treatment plans that have been through review, and the scope is described in terms of serious, rare and intractable disease. Cosmetic and aesthetic purposes are not mentioned in that description. Keeping this separate from the FDA material above matters in both directions. US documents describe what may be marketed in the United States and cannot tell you what is permitted in a clinic in Seoul; the Korean framework sets domestic requirements and says nothing about US approval status. Registration categories, permitted claims and recognised indications are decided country by country, which is exactly why a claim borrowed from one system to reassure about another should be treated as an unanswered question. If a procedure is presented to you as advanced regenerative medicine, the concrete version of that question is which institution designation and which reviewed plan it is performed under, and whether that can be shown in writing.
Sources: Korea — advanced regenerative medicine integrated management portalFDA consumer alert — regenerative medicine products including stem cells and exosomes
A short and specific list. The International Society for Stem Cell Research, in the resources it publishes for patients, describes established stem cell treatment as hematopoietic stem cell transplantation for disorders of the blood and immune system, together with skin and corneal grafts. Cosmetic and anti-ageing use does not appear among them. The same patient resources set out features that should prompt caution: one treatment presented as able to address many different conditions, claims that a procedure carries no risk, and treatments requiring large out-of-pocket payment. None of that is a verdict on any particular clinic or menu. It is a way of noticing the moment a description shifts from what has been established to what is being asserted — a distinction a listing page cannot make on your behalf, and one that becomes harder to make when the material itself has not been named.
Less than the volume of marketing suggests, and a recent review counted it directly. A PRISMA systematic review of exosomes in skin rejuvenation, published in Dermatology Practical & Conceptual in 2026, screened 1,032 records and included 21. The majority of the included work was preclinical — laboratory and animal studies — with human clinical studies numbering roughly seven to eight. The authors conclude that standardised, larger and longer-term clinical trials are still needed, and note the absence of an agreed standard for characterising extracellular vesicles, which makes findings hard to compare between studies. Set beside that is the regulatory position already noted: in the United States, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products, no exosome product is approved, and FDA issued a public safety notification in December 2019 after serious adverse events were reported in Nebraska following the use of exosome products. Early-stage evidence and unapproved status are two separate facts, and both belong in the same discussion.
Sources: Exosomes in skin rejuvenation: systematic review, Dermatol Pract Concept 2026FDA — public safety notification on exosome products (2019-12-06)FDA consumer alert — regenerative medicine products including stem cells and exosomes
A surgical question, examined in a small body of work. A PRISMA 2020 systematic review published in Cureus in 2025 looked at adipose-derived stem cell and stromal vascular fraction enrichment in fat grafting, and included 12 studies: 5 randomised controlled trials and 7 non-randomised prospective studies. The included studies reported improvement in graft retention and in measures of skin quality, and across follow-up extending to four years the review did not report increases in infection, cyst formation, fat necrosis or tumour recurrence. The authors are equally direct about the limits — methodological heterogeneity between studies, non-standardised cell processing methods, and a shortage of long-term data. Two cautions follow from that. This literature concerns cell enrichment of grafted fat in a surgical setting, so it is not evidence about an injection menu whose material has not been identified. And an absence of reported increases across 12 heterogeneous studies is a description of what those studies recorded, not a safety conclusion that transfers to a different procedure.
Sources: Adipose-derived stem cell and SVF enrichment in fat grafting: systematic review, Cureus 2025
How long the effect lasts depends entirely on which material and procedure your clinic actually names, and none of the three categories reviewed here point to a single number. For fat grafting enriched with adipose-derived cells or SVF, the 2025 Cureus review followed some study cohorts out to four years and reported improved graft retention within that window, but graft retention is a surgical outcome measured across heterogeneous protocols, not a duration figure that transfers to any other procedure on this menu. For exosome products, the 2026 systematic review found mostly preclinical work and called for standardised, longer clinical trials — evidence at that stage does not support a duration claim in either direction. Ask your clinic to name the exact material first, then ask what timepoint their own outcome data, if any, was measured at, and whether that data comes from a controlled study or from their own case series.
Sources: Adipose-derived stem cell and SVF enrichment in fat grafting: systematic review, Cureus 2025Exosomes in skin rejuvenation: systematic review, Dermatol Pract Concept 2026
They are documented, and they are serious. FDA’s patient and consumer information on regenerative medicine therapies covers unapproved products including stem cells, stromal vascular fraction — fat-derived cells — and umbilical cord blood, and lists harms reported after their use: blindness, tumour formation and infections, including bacterial infections that have been life-threatening blood infections. On 11 May 2026 FDA issued a further warning to patients and consumers about unapproved products derived from human cells or tissues, citing reports of serious harm including deaths, and stating that it has not reviewed or verified the quality, safety, purity or potency of those products. This record and the fat-grafting review in the previous section have to be held side by side rather than traded against each other: one is a body of adverse event reports concerning unapproved products marketed in the US, the other is a small, non-standardised set of clinical studies in surgical fat grafting. Neither cancels the other out, and this page does not claim to resolve which pattern would apply to a material that has not been named.
Sources: FDA — important patient and consumer information about regenerative medicine therapiesFDA — patient and consumer warning about unapproved products from human cells or tissues (2026-05-11)Adipose-derived stem cell and SVF enrichment in fat grafting: systematic review, Cureus 2025
Identify the material first, because nothing else can be assessed until that is fixed. Ask what exactly is used — cells separated from your own fat, a preparation made from your own blood, a culture supernatant, or an exosome product — and ask for that in writing rather than as a category word. Ask whether cells are used on the day they are obtained or expanded in a laboratory first, since that is precisely the kind of processing a regulatory test turns on. Ask what the volume figures refer to, whether any harvesting procedure is involved, and what that means for you as a separate procedure with its own recovery. Ask for the product name and manufacturer, and under which registration or framework the procedure is performed in the country where you are being treated — including which designation and which reviewed plan, if it is presented as advanced regenerative medicine. Ask what happens if a problem appears after you have flown home, who reviews it and how they are reached. Specific answers give you what you need in order to decide; an answer made of reassurance is, in the terms ISSCR uses with patients, a reason to slow down rather than to book.
Sources: FDA guidance — HCT/Ps: minimal manipulation and homologous useKorea — advanced regenerative medicine integrated management portalISSCR — stem cell resources for patients
This table separates categories that a single marketing word covers. It is not a ranking and not an efficacy comparison: the rows come from regulatory documents and systematic reviews that used different methods and asked different questions, and every regulatory statement in the third column describes the United States only.
| Category | What it refers to | Documented status in the United States (US only) | Evidence cited here, and what to confirm |
|---|---|---|---|
| Blood-forming stem cells from cord blood | Hematopoietic progenitor cells derived from umbilical cord blood, used in transplantation | The only stem cell products FDA describes as approved for use in the United States | ISSCR describes hematopoietic stem cell transplantation for blood and immune system disorders, with skin and corneal grafts, as established treatment; those indications are defined diseases and cosmetic use is not among them |
| Fat-derived cells (SVF, adipose-derived stem cells) | The cell-containing fraction separated from a person’s own fat tissue, with or without laboratory expansion | Named by FDA among unapproved products offered to consumers, alongside stem cells and umbilical cord blood; whether such a product falls under 361 HCT/P rules or drug and biological product rules turns on minimal manipulation and homologous use at 21 CFR 1271.10(a) | A PRISMA 2020 review of 12 studies (5 randomised, 7 non-randomised prospective) in fat grafting reported improved graft retention and skin quality measures, and no reported increase in infection, cyst formation, fat necrosis or tumour recurrence out to four years, while naming heterogeneity, non-standardised processing and missing long-term data as limits. Confirm whether cells are expanded, and whether the setting resembles the one studied |
| Exosomes and extracellular vesicles | Vesicles released by cells, not cells themselves; a culture supernatant that cells were grown in is a further, separate thing again | FDA states there are no approved exosome products, and that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products; a public safety notification followed serious adverse events reported in Nebraska in 2019 | A 2026 PRISMA review screened 1,032 records and included 21, most of them preclinical, with roughly seven to eight human clinical studies, and calls for standardised larger trials with longer follow-up in the absence of a characterisation standard. Confirm the exact product, its source material, and what documentation exists for its contents |
| This menu as listed | Listed in English as Premium Regenerative Skin Therapy and in Korean as a stem cell item, in 30 cc, 60 cc and 120 cc variants plus a one-day package; the material is not stated and the volume figures are not defined | Cannot be stated, because status follows from the material and the material has not been identified | No body of evidence can be matched to it until it is identified. Confirm the material, the processing, what the volume figures mean, the product name and manufacturer, and the framework it is performed under |
Every regulatory statement above describes the United States and is presented as such. Korea’s advanced regenerative medicine route is a separate system with its own requirements, and nothing here states what is permitted at any particular clinic. Systematic review findings describe the studies that were pooled rather than an individual outcome, and no row is a recommendation to have or to avoid a procedure.
Sources: FDA consumer alert — regenerative medicine products including stem cells and exosomesFDA — important patient and consumer information about regenerative medicine therapiesFDA — public safety notification on exosome products (2019-12-06)FDA guidance — HCT/Ps: minimal manipulation and homologous useISSCR — stem cell resources for patientsExosomes in skin rejuvenation: systematic review, Dermatol Pract Concept 2026Adipose-derived stem cell and SVF enrichment in fat grafting: systematic review, Cureus 2025Korea — advanced regenerative medicine integrated management portal
Care is provided by the medical team at the branch you select. These clinicians lead the three branches linked from this guide; confirm the doctor assigned to your visit with that branch.
Chief MD, Gangnam
The trust our patients have placed in this clinic was built on conviction and principle. We intend to hold to both, unchanged, through the next hundred years.
Chief MD, Myeongdong
I want to be thinking about how the patient feels right up to the last moment of the procedure.
Chief MD, Hongdae
I will give my best with the attentiveness to catch even the smallest change.
Listed branch medical team — not a medical-review byline for this article.
It is a category word used in marketing, not a regulatory classification, and on its own it identifies nothing. FDA uses regenerative medicine products as a consumer-facing heading that spans cell-based products and exosome products together, while the rules applying to each differ: cells may fall under 361 HCT/P rules or under drug and biological product rules depending on how they are processed and what they are used for, and FDA states exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products. So the word tells you neither the material, nor the processing, nor the registration status. The single question that resolves all three is what exactly is being injected, answered by name and in writing.
Stromal vascular fraction is the cell-containing fraction obtained when fat tissue is processed, and FDA names it as fat-derived cells in its patient and consumer information about unapproved regenerative products. Cultured means something different: cells grown and multiplied in a laboratory before they are used. That difference is not cosmetic in regulatory terms, because the US test at 21 CFR 1271.10(a) turns on whether the processing alters the relevant biological characteristics of the cells, so whether cells are expanded in culture is exactly the kind of fact that decision depends on. Ask which one applies, ask where the processing happens and by whom, and note that two menus using the same headline word can sit in different categories on this point alone.
The proposed mechanisms differ by material, and the published record is at an earlier stage than the explanations suggest. Cells are delivered as cells; exosomes are vesicles released by cells and carry signalling contents rather than being cells at all; a culture supernatant is the fluid cells were grown in. For skin, the 2026 systematic review of exosomes screened 1,032 records and included 21, most of them in vitro or animal work, with roughly seven to eight human clinical studies, and its authors note there is no agreed standard for characterising the vesicles themselves. That is a field still establishing its methods, so a mechanism described confidently at a consultation is a hypothesis under study rather than something the literature has settled in people.
They differ by category before they differ in anything else, and no cited source compares them head to head. Cells are cells, and in the US their classification depends on minimal manipulation and homologous use; exosomes are cell-derived vesicles, FDA states that none are approved, and that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products. The evidence bases are separate too: the exosome review included 21 studies, mostly preclinical, while the fat grafting review included 12 clinical studies in a surgical context with non-standardised processing. Nothing in either literature supports treating the two as interchangeable versions of one idea, and a clinic that presents them that way has not answered the question you asked.
They answer different questions, and neither substitutes for the other. FDA documents state what may be marketed in the United States: blood-forming stem cells from umbilical cord blood are described as the only approved stem cell products there, and no exosome product is approved. Korea’s advanced regenerative medicine portal describes a domestic route instead — designated institutions, research or treatment plans that have been through review, and a scope described in terms of serious, rare and intractable disease. A procedure performed in Korea is governed by Korean requirements, so FDA wording about US legality says nothing about it, and a Korean listing says nothing about US status. Ask which framework applies where you are being treated, and ask for the answer in writing rather than as a verbal assurance.
No, and sharing a word does not put two procedures in the same evidence category. ISSCR’s patient resources describe established stem cell treatment as hematopoietic stem cell transplantation for disorders of the blood and immune system, along with skin and corneal grafts — procedures with defined disease indications, done in defined clinical settings. Cosmetic and anti-ageing uses are not listed among them. ISSCR also names warning signs that are useful here: one treatment offered for many different conditions, claims that there is no risk, and large out-of-pocket payment. Those signs describe how a claim is presented, not whether a specific clinic is at fault, and they are worth applying to any description that is confident about a material it has not named.
No figure can honestly be quoted, because none of the sources cited on this page reports pain scores or downtime for an aesthetic regenerative procedure. What can be said is that the answer depends on a material and a method that have not been specified: if fat is harvested, that is a separate procedure with its own recovery, and a blood draw or an injection of a prepared product is different again. Ask the clinic to describe each step that will be performed on you, including anything done to obtain the material, and what is expected afterwards for that exact process. One specific caution from ISSCR applies to the answer you receive: a statement that a procedure carries no risk is listed there as a warning sign rather than as reassurance.
This checklist is general post-procedure safety guidance rather than a finding of the studies cited on this page. Contact the clinic promptly for spreading redness or warmth, pain that increases instead of settling, swelling, drainage or pus, fever or chills, or a lump that grows or does not settle. Seek emergency care for breathing difficulty, fainting, sudden swelling of the lips, mouth, tongue or throat, or any sudden change in vision. The reason for naming those clearly is that FDA lists blindness, tumour formation and infections including life-threatening blood infections among harms reported after unapproved regenerative products in the US. Before travelling, settle how the clinic is reached from abroad, who reviews photographs or reports after you leave, and which local clinician you would see first.
That cannot be answered from the sources here, and the reason is itself informative: no course schedule can be read from the published record for a material that has not been identified. What the listing shows is volume variants of 30 cc, 60 cc and 120 cc plus a one-day package, without stating whether those figures describe fat harvested, material processed or material injected. Ask for the plan in writing — how many visits, what is done at each, what the volume figures refer to, and what any follow-up visit is for. A plan that specifies a number of sessions before it specifies the material has answered the easier question first.
Suitability cannot be judged from a menu, and here it cannot even be framed until the material is named, so this belongs in an in-person assessment with your full history in front of the clinician. What is documented is the adverse event record for unapproved products in the US: FDA lists blindness, tumour formation and infections including life-threatening blood infections among reported harms; its 11 May 2026 warning about unapproved products derived from human cells or tissues cites reports of serious harm including deaths, and states FDA has not reviewed or verified those products’ quality, safety, purity or potency; and the December 2019 public safety notification followed serious adverse events reported in Nebraska after exosome products. Disclose any history of cancer, any immune condition, and any anticoagulant or immunosuppressant use, and ask directly which of those the clinic considers relevant and why.
No, and the two documents have to be read together rather than one used to dismiss the other. The Cureus systematic review pooled 12 studies, 5 randomised and 7 non-randomised prospective, and across follow-up extending to four years did not report increases in infection, cyst formation, fat necrosis or tumour recurrence. The same review names its own limits: methodological heterogeneity, non-standardised cell processing, insufficient long-term data. Separately, FDA lists tumour formation among harms reported after unapproved regenerative products in the US. Twelve heterogeneous studies in surgical fat grafting neither confirm nor refute those reports, and this page does not resolve the question in either direction — which is why the material, the processing and the setting need to be named before any of this evidence is applied to you.
For the United States the position is stated and narrow: FDA describes blood-forming stem cells, hematopoietic progenitor cells derived from umbilical cord blood, as the only stem cell products approved for use there, and states there are currently no approved exosome products. That alert does not address cosmetic use at all, so it should not be read as a ruling on skin menus in either direction. Beyond the US, registration categories and recognised indications are decided country by country, and this page carries no verified statement of what is authorised in Korea for the item in question. So the usable step is documentary rather than argumentative: ask for the product name, the manufacturer, and the registration or framework it is used under, in writing.
Align the material and the process before you compare any amount, because two quotes carrying the same headline word may describe different products in different regulatory categories. Establish what material each quote covers, whether cells are used the same day or expanded in a laboratory, whether harvesting is a separate procedure and whether it is billed separately, what the volume figures refer to, how many visits are included and over what period, what follow-up and management of complications are included, and what documentation you receive naming the product and its manufacturer. Until those line up, the totals are answers to different questions. A quote that cannot state the material is not yet a quote you can compare.
That is a clinical judgement made in person, and for this item it cannot even be posed until the material is identified. Two anchors frame what the sources do and do not say. ISSCR describes established stem cell treatment as confined to hematopoietic transplantation for blood and immune disorders and to skin and corneal grafts, and Korea’s advanced regenerative medicine portal describes its scope in terms of serious, rare and intractable disease — neither addresses cosmetic use. That silence is not a verdict on this menu; it means the suitability question has to be answered by the treating clinician, on the record, with the material named and the framework stated. If the answer arrives as reassurance instead of specifics, ISSCR’s warning signs are a reasonable checklist to apply before deciding.
We started in Gangnam in 2006 and the network now runs 17 branches across Korea. The line we work to is skin transformation woven into everyday life — care you can keep up with, rather than one dramatic change.
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