Regulatory Status: What Is Approved, What Is Not, and Where This Treatment Sits

The treatment offered here is not FDA-approved. This page explains precisely why, what category it falls into, and how to check any cell therapy's status yourself.

Verification note: FDA approval details below were retrieved from the FDA's own product labelling via the openFDA API on 29 July 2026. Regulatory status changes — verify before relying on anything here.

The Two US Pathways, and Which One This Is

Human cells and tissues are regulated under 21 CFR Part 1271³. There are two routes.

Section 361 — the narrow exemption

An HCT/P is regulated solely under section 361 (no premarket approval required) only if it meets all four criteria in 21 CFR 1271.10(a):

1. Minimally manipulated — processing must not alter the relevant biological characteristics
2. Intended for homologous use only — it performs the same basic function in the recipient that it performed in the donor
3. Not combined with another article, with narrow exceptions
4. Either it has no systemic effect and is not dependent on the metabolic activity of living cells, or it does, and is autologous, for a first- or second-degree blood relative, or for reproductive use

⚠️ *Note what is not on that list.* "Same-day procedure" is not a criterion. "Autologous" alone is not sufficient — an autologous product can still be a 351 biologic if it is culture-expanded or used non-homologously.

Section 351 — the drug pathway

Anything failing any one of those criteria is a biological drug. It requires:

• An Investigational New Drug (IND) application before it can lawfully be studied in people
• Clinical trials
• A Biologics License Application (BLA) approved before it can be marketed

⛔ Where the treatment offered here sits

The product used by Sterling-certified partner clinics is umbilical cord-derived mesenchymal stromal cells, culture-expanded, allogeneic, administered intravenously for systemic indications.

Against the four criteria:

It fails at least three of the four. It is a 351 biologic.

In the United States it could lawfully be given only under an IND, in a clinical trial. It is not FDA-approved, and we are not going to describe it as anything else.

What Is Actually Approved

RYONCIL — the first and only approved MSC product

Retrieved from the FDA's approved labelling¹:

Approved in December 2024, it is described in the literature as the first approved cellular therapy for steroid-refractory acute GVHD, with roughly 70% response rates and ~70% six-month survival in the supporting data².

⚠️ Read this in both directions, because both matter.

⭐ It proves the 351 pathway is passable. A culture-expanded allogeneic MSC product went through IND, trials and a BLA, and now holds a licence⁹. Cell therapy is not categorically unapprovable.

⛔ And it shows how narrow approval is when it comes. One product. One indication. Paediatric patients with steroid-refractory GVHD. Not osteoarthritis, not COPD, not autoimmune disease generally, not anti-ageing, not any wellness indication. Approval of one MSC product for one condition is not approval of MSC therapy as a category, and anyone implying otherwise is misrepresenting it.

Other approved cell products

Several cord blood-derived haematopoietic progenitor cell (HPC) products hold BLAs for use in haematopoietic reconstitution in specified disorders. These are established transplant products, not the same category as cultured MSC therapy.

In the European Union

Cell therapies are regulated as Advanced Therapy Medicinal Products (ATMPs)⁴, requiring a marketing authorisation. Approved products include:

• Holoclar — limbal stem cells for corneal damage from eye burns
• Alofisel (darvadstrocel) — complex perianal fistulas in Crohn's disease. ⚠️ Its confirmatory trial did not meet its primary endpoint and its authorisation status has been subject to review — verify current status before relying on this entry
• Strimvelis — a gene therapy for ADA-SCID

How to Check Any Product's Status Yourself

This is the part worth learning, because it settles arguments.

1. FDA's approved cellular and gene therapy products list — search FDA approved cellular and gene therapy products. If a product is not on that list, it is not FDA-approved. There is no second list
2. openFDA label search — api.fda.gov/drug/label.json?search=openfda.brand_name:"NAME" returns the approved labelling, including the BLA number and the exact approved indication
3. Ask any provider for the BLA or IND number. An approved product has a BLA. A lawful US investigational product has an IND and a corresponding registered trial. A provider who has neither is offering something outside both pathways
4. Check the indication, not just the product. Approval is always for a specific condition in a specific population. "It's FDA-approved" without an indication is not a meaningful statement

⚠️ Terms that are not approvals

We hold ISO 9001:2015 certification and our partner laboratories operate to GMP standards. Both are real and both are worth having. Neither is an approval, and we are not going to present them as one.

Thailand — and what we could not verify

Sterling-certified partner clinics operate in Thailand.

⚠️ We are not able to give you a properly sourced account of Thai cell therapy regulation, and we would rather say that than assert something we cannot support.

What we can say: Thailand has a Food and Drug Administration under the Ministry of Public Health, and our partner facilities hold licences issued under Thai law. What we cannot currently point you to is a public, citable Thai regulatory instrument setting out how cell therapy products are classified and what those licences permit. One peer-reviewed 2026 commentary describes Thailand's framework for advanced therapy medicinal products as "emerging"⁵ — which is a weaker statement than "established", and is the strongest independent characterisation we could find.

What follows from that, honestly stated:

• A licence to operate a facility is not an evaluation of a therapy. The two are different things in every jurisdiction
• A different regulatory regime is not the same as a more permissive verdict on the same evidence. Countries regulate differently for many reasons; that a treatment is available somewhere does not mean anyone has concluded it works
• ⚠️ Be sceptical of any specific claim about legal protections for international patients, including from us. Recourse across jurisdictions is genuinely limited and varies — assume less protection than at home, not more, and get it in writing if it matters to you

Questions worth asking any overseas provider:

1. Under what specific licence or authorisation is this product supplied, and can I see it?
2. What is the product's regulatory classification in this country?
3. Has any regulator, anywhere, evaluated this product for my condition?
4. What happens if something goes wrong, and under whose law?

US Enforcement

The FDA has taken action against clinics marketing unapproved cell products, including warning letters and court proceedings seeking injunctive relief. Independent surveys have documented a large direct-to-consumer stem cell industry operating outside the approval pathways⁶, and the tension between medical innovation and unproven commercial treatment has been debated in the literature for over fifteen years⁷.

⚠️ We are not going to summarise specific enforcement actions we have not individually verified. If enforcement history matters to your decision — and it reasonably might — the FDA publishes warning letters in a searchable public database, and it is worth reading them directly.

Legal Considerations for International Patients

Legal

• Travelling abroad for medical treatment
• Receiving treatment lawfully provided in that country
• Paying for it

Generally not legal

• Importing cell products into the US for personal use. The FDA restricts import of biological products; do not attempt to bring cells back
• Marketing an unapproved therapy to US residents as though approved

Understand before you go

• This treatment is not FDA-approved. It is not approved in the EU, the UK, Canada or Australia either
• Insurance generally does not cover out-of-country or experimental treatment. Some policies cover complications — check yours specifically, in writing
• Legal recourse may be limited. Different legal system, different standards, different practical ability to pursue a claim from abroad
• Aftercare is on you. Your own doctor may not have been consulted and may not be willing or able to manage complications from a treatment they did not recommend

Red Flags

Warning signs of a substandard or unregulated operation:

• "FDA approved" when it is not — check the FDA list; there is no ambiguity
• Agency logos or seals in marketing material. No regulator endorses commercial clinics, and reproducing an agency's mark does not make it so
• Award-style badges or "certification" seals that no named body issues
• ISO or GMP certification presented as evidence the treatment works
• Cure claims, or claims of efficacy across many unrelated conditions
• No visible licences, no documentation, cash-only
• "No questions asked" eligibility — a provider who will treat anyone is not assessing anyone
• Refusal or inability to give you a BLA number, an IND number, or a regulatory classification

What We Do and Do Not Claim

We do claim:

• Our partner facilities hold licences issued under Thai law and operate to GMP standards
• We hold ISO 9001:2015 certification
• Every treatment is supplied with a Certificate of Analysis documenting the specific batch
• We disclose the regulatory status of what we offer

We do not claim:

• ⛔ That this treatment is FDA-approved, EMA-approved, or approved by any regulator anywhere
• ⛔ That ISO or GMP certification indicates the treatment is effective
• ⛔ That any regulatory body has endorsed it
• ⛔ That operating lawfully in one jurisdiction constitutes evidence of efficacy

Frequently Asked Questions

Is stem cell therapy FDA-approved?

One MSC product is: RYONCIL, for steroid-refractory acute GVHD in children¹. Several cord blood HPC products are approved for haematopoietic reconstitution. Nothing else. The treatment offered here is not approved, in the US or anywhere else.

Why isn't it approved if it's used so widely?

Because approval requires trials demonstrating benefit in a specific condition, and for most indications those trials have not been done or have not shown a clear enough result. Widespread commercial availability and regulatory approval are independent of each other.

Is it legal for me to receive treatment in Thailand?

Travelling for treatment and receiving lawfully provided care abroad is legal for US residents. ⚠️ What we cannot fully source is the detail of Thai cell therapy regulation — see above. Ask the provider directly for their licence and the product's classification.

Can I bring cells back to the US?

Generally no. The FDA restricts import of biological products for personal use.

Is your facility certified?

Our partner facilities hold Thai licences and ISO 9001:2015 certification. ⚠️ Neither is an approval of the treatment, and we would be misleading you if we implied otherwise.

What does "351" mean for me practically?

It means the product would be regulated as a drug in the US, that it has not completed the approval process for your condition, and that you are receiving something whose benefit has not been established to a regulator's satisfaction. That may still be a decision you want to make. It should be an informed one.

Resources

Regulatory bodies: FDA (fda.gov) · EMA (ema.europa.eu) · MHRA (gov.uk/mhra) · PMDA (pmda.go.jp) · Thai FDA (fda.moph.go.th)

Check a product: FDA approved cellular and gene therapy products list · openFDA (api.fda.gov) · FDA warning letter database

Find a trial: ClinicalTrials.gov · WHO ICTRP · EU CTIS

Guidance: ISSCR Guidelines for Stem Cell Research and Clinical Translation⁸ — including its patient-facing material on evaluating claims