Download: Printable checklist for your consultations
What This Checklist Can and Cannot Do
These questions test a clinic's process, transparency and accountability. They can tell you
whether an operation documents what it does, whether it will put its claims in writing, and what
happens to you if something goes wrong.
They cannot tell you whether the treatment works. That is a separate question, and the honest
answer for most stem cell treatments sold commercially is that it has not been established. A clinic
can answer every question below impeccably and still be selling something with no demonstrated
benefit for your condition. Keep the two questions apart, and ask both.
Three things worth knowing before you start.
One: these cells probably do not do what the brochure implies. Mesenchymal stromal cells do not
engraft, replace your tissue, or become new organs in any meaningful quantity after an intravenous
infusion. The researcher who named them has argued at length that "stem cell" is the wrong word and
that they act mainly as signalling cells, secreting factors that modulate the local environment
before being cleared within days. [1]The broader literature describes them the same way — as cells
that home to injured tissue and modulate inflammatory and immune responses, rather than rebuilding
it. [12]
Two: the field's advanced trials have largely underdelivered. A 2018 review in Cell Stem Cell
put it directly: *"the outcomes of advanced clinical trials have fallen short of expectations raised
by encouraging pre-clinical animal data in a wide array of disease models."* [2]The same review notes
that the field still lacks agreed potency assays — meaning there is often no validated way to
establish that one batch of cells is better than another. [3]**Any clinic telling you the science is
settled is telling you something the field's own literature does not.**
Three: know what an approved product actually looks like. As of this writing the only
FDA-approved mesenchymal stromal cell product in the United States is RYONCIL (remestemcel-L-rknd),
licensed under BLA 125706 for one narrow indication: steroid-refractory acute graft-versus-host
disease in paediatric patients two months and older. [4]It is worth knowing its properties, because
several of them contradict what commercial clinics commonly present as quality markers:
If a clinic tells you that frozen cells are a red flag, that shipped cells are a red flag, or that
centrally manufactured cells are a red flag, note that **the one product that cleared FDA review is
all three.**
Part 1 — Regulation and Legal Status
1. Is this product approved by a regulator for my condition — and if not, under what legal basis are you providing it?
Why it matters: This is the first question, and most clinics are never asked it. Approval means an
agency has reviewed manufacturing, safety and efficacy data. Almost no commercially sold stem cell
treatment has it. That is not automatically disqualifying, but you are entitled to know which
situation you are in.
A good answer contains: A direct statement — approved, or not approved. If not approved, the
specific legal mechanism: a clinical trial with a registered protocol, a named regulatory exemption,
or a national framework with a document you can be shown.
A bad answer sounds like: "It's fully legal here." "Regulations are different in this country."
"It's not FDA-approved because the FDA is slow." Deflection to another country's rules without naming
the rule.
How to verify: Ask for the authorisation in writing, with a number. Approvals and licences have
identifiers. Then check the identifier with the issuing agency directly, not through the clinic.
2. What is the regulatory status of this specific product in the country where I will be treated?
Why it matters: "Legal to provide" and "reviewed for efficacy" are different things in every
jurisdiction. A clinic may operate lawfully while its product has never been assessed for whether it
works.
A good answer contains: The name of the regulator, the category the product falls into, and what
that category does and does not require.
A bad answer sounds like: "We're fully licensed." (Licensed by whom, to do what?) "The clinic is
government-approved." (A clinic licence is not a product authorisation — these are different
documents.)
How to verify: Ask which document the clinic holds — a facility licence or a product
authorisation — and request a copy of each. Confirm with the named agency.
3. Is this treatment part of a registered clinical trial? If so, which one?
Why it matters: If it is a trial, there is a protocol, oversight, and usually no charge. **If you
are paying, it is generally not a trial** — and a clinic that uses trial language while charging you
is blurring a distinction that matters legally and medically.
A good answer contains: A registry identifier — an NCT number, ISRCTN, or national equivalent —
or a clear statement that this is not a trial.
A bad answer sounds like: "It's an ongoing study." "We're collecting data." "It's part of our
research programme." Research-flavoured language with no identifier.
How to verify: Look the number up yourself at clinicaltrials.gov or the relevant registry. Check
that the record's condition, phase, sponsor and recruitment status match what you were told. A
registry number that resolves to a different study, or does not resolve at all, ends the conversation.
Part 2 — Evidence
4. What is the evidence for this treatment in my specific condition?
Why it matters: Evidence in one disease does not transfer to another. Nor does evidence in mice
transfer to people, or evidence in severely ill patients transfer to well ones.
A good answer contains: Named studies, in your condition, in humans, that you can go and read.
A bad answer sounds like: "There are thousands of studies." "The research is very promising."
Papers in unrelated diseases. Animal studies presented without saying they are animal studies.
How to verify: Ask for the citations in writing. For each one check four things: **is it in
humans, is it in my condition, how many patients, and was there a comparison group?** You do not need
a science background — those four facts are usually in the abstract, free to read.
5. Is there a comparator arm anywhere in the evidence you have shown me?
Why it matters: This is the single most powerful question on this page, and the one clinics are
least prepared for. Without a control group you cannot tell a treatment effect from natural recovery,
regression to the mean, or placebo. Many conditions improve on their own; nearly everyone feels
better after attentive care in a pleasant setting.
A good answer contains: "Yes — here is the randomised trial." Or an honest "No, the data we have
is uncontrolled, so it cannot establish that the treatment caused the improvement."
A bad answer sounds like: "Our patients improve — that's the evidence." "It would be unethical to
withhold treatment." "Every patient is different, so trials don't apply."
How to verify: In the papers you were given, look for the words randomised, placebo,
control, or sham. If none appear in any of them, the clinic has no evidence that the treatment
caused anything.
6. Has anyone published outcomes from this clinic? Where can I read them?
Why it matters: Testimonials are selected. Published outcomes are not. A clinic treating large
numbers over several years and publishing nothing has made a choice about scrutiny.
A good answer contains: A citation, a preprint, a registry submission — something with an author
list and a date that exists outside the clinic's own website.
A bad answer sounds like: "We have thousands of satisfied patients." "We're preparing a
publication." "Our results are confidential." Video testimonials offered in place of data.
How to verify: Search the clinic name and the physicians' names in PubMed and Google Scholar. Both
are free. Absence of results is itself an answer.
7. What outcome are we trying to change, how will we measure it, and when?
Why it matters: Without a pre-agreed endpoint, any result can be described as success afterwards.
A measurement decided in advance is a commitment; one decided afterwards is a narrative.
A good answer contains: A specific, measurable outcome with a timeframe — walking distance,
range of motion, a validated symptom score, a lung function value — recorded before treatment and at
defined intervals after.
A bad answer sounds like: "You'll feel more energy." "Most people notice improvements in
6–12 weeks." "We track biomarkers." Improvement in a blood marker is not improvement in your life.
How to verify: Ask for the measurement plan in writing before you pay, and ask who does the
measuring. Ask what result would count as failure — a clinic that has no failure criterion cannot
report one.
Part 3 — The Product
8. What exactly is being administered — cell type, tissue source, and how it was processed?
Why it matters: "Stem cells" covers products that are not comparable. Tissue source, isolation
method and culture expansion all change what you receive, and cells from different sources differ
measurably in expansion potential and differentiation. [5]
A good answer contains: The cell type, the tissue of origin, whether cells were culture-expanded,
how many passages, and whether the product is a cell suspension or a cell-free preparation.
A bad answer sounds like: "Stem cells." "A proprietary formulation." "Our own protocol." Any
answer where the product is a trade secret.
How to verify: Ask for the product specification in writing. Note that **umbilical cord blood and
umbilical cord tissue are different products** with different cells — if a clinic uses the terms
interchangeably, that is informative.
9. What dose will I receive, and what is that based on?
Why it matters: More is not better, and this is where marketing and evidence diverge most sharply.
In the two published trials of MSC infusion for aging frailty, the 100-million dose improved
physical performance and the 200-million dose did not. [6][7]A survey of 914 MSC trials found
effective doses clustering at *100–150 million, with lower and higher* intravenous doses less
effective.** [8]The approved product doses by body weight and repeats, rather than delivering one large
headline number. [4]
A good answer contains: A specific dose, and a stated rationale linked to published dose-finding
data or to body weight.
A bad answer sounds like: "The highest dose available." "More cells, better results." "Up to X
million." A number offered as a premium upgrade.
How to verify: Ask which study the dose comes from, then read it. **If a clinic offers you a
larger dose for more money, ask them to show you the evidence that larger is better.** On current
published data, they cannot.
10. Are the cells fresh or cryopreserved — and why does your answer matter clinically?
Why it matters: This is frequently sold as a quality differentiator in both directions, and the
evidence is weaker than the marketing. Controlled cryopreservation in clinical-grade medium recovers
about 95% of cells as live cells, and in the same study **proliferation was not compromised and
was even enhanced**, surface markers were unchanged, and differentiation matched unfrozen parallel
cultures. [9]**The one FDA-approved MSC product is cryopreserved and shipped frozen in liquid
nitrogen.** [4]
A good answer contains: A factual description of the process, and an acknowledgement that both
approaches are used in legitimate practice.
A bad answer sounds like: "Fresh cells are always superior — frozen cells are damaged." "Anyone
using frozen cells is cutting corners." Confident claims in either direction presented as settled.
How to verify: Ask for the release criteria — viability threshold, sterility, endotoxin — and who
signs them off. The process controls matter; the freshness marketing mostly does not.
11. What is the cell viability at release, what is your release threshold, and who verifies it?
Why it matters: Viability is a real, measurable release criterion and worth asking about. But be
clear about what it tells you: **there is no established evidence that viability above standard
release thresholds predicts your clinical outcome.** It is a manufacturing quality control, not a
predictor of benefit. A clinic presenting a high viability percentage as a proxy for efficacy is
overstating what the number means.
A good answer contains: A threshold, the assay used, the timing relative to administration, and
an external or independent verification step.
A bad answer sounds like: "Industry standard." "Very high." A percentage with no assay named. A
guaranteed number — biological products vary, and a guarantee is a marketing claim.
How to verify: Ask for a batch Certificate of Analysis and ask who issues and countersigns it.
A CoA produced by the same operation that sells you the product is not independent verification.
12. What donor screening was performed, and can I see the screening panel?
Why it matters: For allogeneic (donor) cells this is a genuine safety issue — infectious disease
transmission through cell products is a documented risk, not a theoretical one.
A good answer contains: The specific infectious disease panel, the testing intervals, and the
donor eligibility criteria.
A bad answer sounds like: "All donors are fully screened." "Rigorous screening protocols."
Screening described without a single test named.
How to verify: Ask for the panel list in writing and compare it against your own country's tissue
donor standards. Note that donor age is a separate question from donor screening — donor age
affects cell properties in the laboratory, [10]but screening is what protects you from infection.
Part 4 — The People and the Process
13. Who is my treating physician — name, qualifications, and registration number?
Why it matters: This is the most verifiable question you can ask, and therefore one of the most
useful. A named, registered physician can be checked in minutes.
A good answer contains: A full name, a medical registration or licence number, the issuing body,
and the specialty.
A bad answer sounds like: "Our medical team." "A medical coordinator will look after you." A
physician named only on arrival. Credentials described but not evidenced.
How to verify: Look up the registration number with the national medical council of the country
where you will be treated. Ask before you travel, not after. A clinic that will not name your
physician before you pay has answered the question.
14. Who administers the treatment, and what happens if I react during the infusion?
Why it matters: Intravenous cell infusions can cause acute reactions. What matters is who is in
the room and what is available.
A good answer contains: The clinical qualification of the person administering, resuscitation
equipment on site, and a named escalation pathway to a hospital.
A bad answer sounds like: "It's a very simple procedure." "Reactions don't happen here." Any
answer that does not name a nearby hospital.
How to verify: Ask which hospital, how far, and whether there is a transfer agreement in writing.
15. What would make me not a candidate — and what proportion of enquiries do you decline?
Why it matters: This is the question that reveals the most, because it asks the clinic to describe
its own limits. **An operation that treats nearly everyone who enquires is a sales process with a
medical procedure attached.**
A good answer contains: Specific exclusion criteria — active malignancy, active infection,
immunosuppression, pregnancy, uncontrolled comorbidity — and a rough decline rate the clinic is
willing to state.
A bad answer sounds like: "Almost everyone is a candidate." "We can help most conditions." An
exclusion list that contains only administrative items.
How to verify: Ask what they told the last person they turned away. Ask whether anyone reviews
candidacy who is not paid on conversion.
16. Will you send my full records to my own doctor?
Why it matters: Continuity of care is a basic standard and a reliable integrity signal. If
something happens weeks later, at home, your own physician needs to know what you received.
A good answer contains: Yes, unprompted, within a defined period, including the product
specification, batch identifier, dose and any adverse events.
A bad answer sounds like: "You'll receive a summary." "We can provide records on request."
Reluctance to communicate with your regular doctor at all.
How to verify: Give them your doctor's details at consultation and ask for confirmation when the
records are sent. Tell your own doctor beforehand that you are considering this — the reaction of
a clinic to that sentence is informative.
Part 5 — Safety, Harm and Recourse
17. What is your adverse event rate — over how many patients, and how do you know?
Why it matters: A rate without a denominator is not a rate. The question is not whether
complications occur; it is whether the clinic counts them systematically.
A good answer contains: A number, a denominator, a defined follow-up period, and a description of
how events are captured — who asks, when, and what happens to the answer.
A bad answer sounds like: "We've never had a complication." (Statistically implausible, and it
means they are not counting.) "Complication rates are consistent with published literature." (This is
the same evasion as "industry standard" — it contains no number.) "Completely safe."
How to verify: Ask how a patient who developed a problem three weeks after flying home would
appear in their statistics. If there is no mechanism, the rate is a guess.
What the published safety data actually says, so you have a benchmark: the most-cited systematic
review of intravascular MSC therapy identified 36 studies with 1,012 participants, of which **8
were randomised trials enrolling 321 participants. Meta-analysis found no association** with acute
infusional toxicity, organ system complications, infection, death or malignancy — **and a significant
association with transient fever (OR 16.82, 95% CI 5.33–53.10)**. [11]The authors concluded the therapy
appears safe on present evidence and called for larger controlled trials with more rigorous adverse
event reporting.
Note the size. That is 1,012 people, most with serious illness, mostly followed for months. It is
a reassuring short-term signal and it is not a basis for claims of long-term safety in healthy people
receiving repeated infusions.
18. What happens if I am harmed — who is liable, what insurance is in place, and what is my recourse?
Why it matters: Most people never ask, and it is the question with the largest financial and legal
consequence. Treatment abroad frequently means limited recourse: your home health insurance is
unlikely to cover complications from an unapproved treatment received overseas, and litigation across
jurisdictions is slow, expensive and often impractical.
A good answer contains: The name of the insurer, the coverage limit, what the policy covers, which
legal entity carries liability, and which country's courts have jurisdiction.
A bad answer sounds like: "That has never happened." "You'll sign a consent form." "We're fully
insured." A consent form that is really a liability waiver.
How to verify: Ask for the certificate of insurance and the name of the contracting legal entity.
Read the consent form before you travel, and note whether it asks you to waive rights. Ask your
own insurer, in writing, whether complications would be covered.
19. Which risks are you obliged to disclose, and what does the consent process involve?
Why it matters: Consent is a process, not a signature collected on arrival after a non-refundable
payment.
A good answer contains: Written material in advance, time to consider, an opportunity to ask
questions of a clinician who is not selling, and an explicit statement of uncertainty about benefit.
A bad answer sounds like: Consent forms presented on the day. Risk described only verbally.
Documents you cannot take away.
How to verify: Ask for the consent documents before you book. A clinic that will not send them
in advance has told you how the process runs.
Part 6 — Money
20. What does the quoted price include — itemised, in writing?
Why it matters: Medical tourism pricing is often bundled in ways that make comparison impossible.
Itemisation makes it possible.
A good answer contains: A written, itemised quote separating the treatment from travel,
accommodation, consultations, imaging, follow-up and any repeat doses.
A bad answer sounds like: "All-inclusive." "The package covers everything." A verbal price. A
figure that changes after assessment.
How to verify: Get it in writing, then ask what is not included. Ask specifically what happens
to the price if the assessment recommends a different protocol.
21. Are follow-up or booster treatments required, at what cost — and what is the refund policy if I am declined or decline?
Why it matters: Loss-leader pricing is a real pattern: an attractive initial quote followed by
"booster" treatments framed as necessary. A fair refund policy is also a genuine integrity signal,
because it prices the clinic's own confidence in its screening.
A good answer contains: A clear statement of whether follow-ups are clinically required or
optional, their cost, and written cancellation terms including what happens if the clinic determines
you are not a candidate on arrival.
A bad answer sounds like: "Results require maintenance." Pressure to book follow-ups before the
first treatment. "All sales final." No stated policy.
How to verify: Get the cancellation terms in writing before paying a deposit. Ask what proportion
of the total is non-refundable at each stage, and what happens if you are declined after travelling.
Understanding Common Evasion Tactics
Downloadable Checklist
Print this and take it to every consultation. Record the answer, then record whether you were able
to verify it. The verification column is the important one — an answer you cannot check is not
information.
┌───────────────────────────────────────────────────────────────────────────┐
│ STEM CELL CLINIC EVALUATION CHECKLIST │
├───────────────────────────────────────────────────────────────────────────┤
│ Clinic: ___________________ Country: ___________ Date: ___________ │
│ VERIFIED? │
│ (doc / no) │
│ REGULATION │
│ 1. Approved for my condition? Legal basis? ______ ☐ doc ☐ no │
│ 2. Regulatory status where I'm treated? ______ ☐ doc ☐ no │
│ 3. Registered trial? Which number? ______ ☐ doc ☐ no │
│ │
│ EVIDENCE │
│ 4. Evidence in MY condition, in humans? ______ ☐ doc ☐ no │
│ 5. Is there a comparator arm? ______ ☐ doc ☐ no │
│ 6. Published outcomes from this clinic? ______ ☐ doc ☐ no │
│ 7. What outcome, measured how, when? ______ ☐ doc ☐ no │
│ │
│ THE PRODUCT │
│ 8. Cell type, source, processing? ______ ☐ doc ☐ no │
│ 9. Dose, and based on what evidence? ______ ☐ doc ☐ no │
│ 10. Fresh or cryopreserved? Release criteria? ______ ☐ doc ☐ no │
│ 11. Viability threshold, assay, who verifies? ______ ☐ doc ☐ no │
│ 12. Donor screening panel? ______ ☐ doc ☐ no │
│ │
│ PEOPLE AND PROCESS │
│ 13. Physician name + registration number? ______ ☐ doc ☐ no │
│ 14. Who administers? Emergency pathway? ______ ☐ doc ☐ no │
│ 15. What would disqualify me? Decline rate? ______ ☐ doc ☐ no │
│ 16. Records sent to my own doctor? ______ ☐ doc ☐ no │
│ │
│ SAFETY AND RECOURSE │
│ 17. Adverse event rate + denominator + method? ______ ☐ doc ☐ no │
│ 18. Liability, insurer, jurisdiction? ______ ☐ doc ☐ no │
│ 19. Consent documents in advance? ______ ☐ doc ☐ no │
│ │
│ MONEY │
│ 20. Itemised written quote? ______ ☐ doc ☐ no │
│ 21. Follow-ups required? Refund terms? ______ ☐ doc ☐ no │
│ │
│ NOTES: ________________________________________________________________ │
│ ______________________________________________________________________ │
│ │
│ How many answers came with a document I could check? ______ of 21 │
└───────────────────────────────────────────────────────────────────────────┘There is no score to total and no threshold to clear. Anyone offering you one — including a
checklist — is inviting you to substitute arithmetic for judgement. What matters is the pattern: which
questions produced documents, which produced assurances, and which produced discomfort.
How to Use This Guide
Before your consultation
- Send questions 1, 2, 3, 13, 18 and 19 by email, in advance. Written answers are evidence;
spoken answers are not.
- Tell your own doctor you are considering this, and ask what they would want to know.
- Read the clinic's own published material and note which claims carry citations.
During your consultation
- Ask every question, including the uncomfortable ones — 5, 6, 15, 17 and 18 are the ones that
distinguish operations.
- Write answers down verbatim. Ask for documents rather than descriptions.
- Notice who answers. Clinical questions answered by sales staff is itself a finding.
After your consultation
- Verify independently: registration numbers with medical councils, trial numbers with registries,
publications in PubMed.
- Compare written quotes, not verbal ones.
- Wait a week before deciding. **Urgency is a sales technique, and no legitimate clinic loses
patience with a person taking time over an elective decision.**