Why a checklist matters more than a brochure
The international stem cell market is a wide spectrum — at one end, hospital-affiliated regenerative medicine departments with peer-reviewed publications and decades of follow-up data; at the other end, sales rooms in shopping malls that quote cell counts over WhatsApp. Both call themselves clinics. Both publish testimonial videos. Both will tell you that they are "the best". The only thing that reliably separates them is what they will put in writing before you pay.
What follows is not a marketing checklist. It is the same set of questions an internal compliance officer would ask if they were auditing a new partner laboratory — translated into language a patient and their family can use. Every question has three parts: what to ask, what an acceptable answer looks like in writing, and the red flag that should make you walk away.
Bring this checklist to every consultation, including ours. We would rather lose a patient who got better answers somewhere else than treat a patient who chose us without doing this homework.
Question 1 — Is the clinic regulated, and by whom?
Every legitimate stem cell clinic operates under a national health authority. In Mexico that is COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios). In the United States, the FDA. In Switzerland, SwissMedic. In the European Union, the EMA together with the national competent authority of each member state. The agency does not matter as much as the clinic's ability to produce, in writing, the specific authorization number that proves the regulator has reviewed the establishment.
Ask: "What is your operating-notice number, and where can I verify it?" In Mexico the answer should be a long alphanumeric Aviso de Funcionamiento — ours is 2323025036X00098 — plus an Aviso de Publicidad authorizing health-related marketing. In the US, expect a facility registration or IRB-approved trial number. The clinic should publish the number on a dedicated regulatory page and welcome verification.
Red flag: vague phrasing such as "COFEPRIS regulated" or "FDA compliant" with no number, or marketing copy that references a regulator the clinic cannot legally claim alignment with. Operating in regulatory gray areas ("international zone", "private practice exemption") is a category of risk that no patient should absorb without explicit, written disclosure.
Question 2 — Who are the actual doctors, by name?
Every cell injection, infusion, and follow-up exam should be performed by a licensed physician — not a nurse, not a sales representative, not a "wellness specialist". The clinic should be able to name, in writing, the physician who will personally administer your protocol, plus the medical director who supervises the program.
Ask: "Who is the treating physician? What is their cédula profesional (Mexico) or state license number (US)? Are they board certified, and in which specialty? How long have they been practicing regenerative medicine specifically?" Every cédula in Mexico is verifiable for free at cedulaprofesional.sep.gob.mx. Every US license is verifiable at the relevant state medical board. Specialist board certifications (orthopedics, internal medicine, sports medicine, regenerative medicine fellowships) are independently verifiable through the issuing board.
Red flag: a website with no named physicians, only "our medical team" stock copy and unattributed headshots. A clinic that will not name its doctors in writing has structural reasons to stay anonymous. Walk away.
Question 3 — What cell types do they offer, and from where?
There is no single "stem cell" — the product varies dramatically by source and processing. The most common clinical preparations are mesenchymal stem cells (MSCs) derived from umbilical cord tissue (Wharton's jelly), placenta, adipose tissue, or bone marrow. Each source has different cell counts, expansion characteristics, and regulatory profiles. Some clinics offer autologous (your own) cells; others use allogeneic (donor) cells. Both are legitimate when properly processed, but the documentation looks completely different.
Ask: "What type of stem cell is in my protocol? Autologous or allogeneic? What tissue source? Where are the cells processed? How are they preserved and shipped to your facility?" A serious clinic answers each in one sentence and follows up with documentation. A clinic that uses MSCs from umbilical cord tissue should be able to name the donor screening protocol and the laboratory that performs the expansion.
Red flag: branded but unspecified products ("Stem-X cells", "our proprietary blend") with no underlying cell type or source disclosed. Branded names are marketing; cells have a biological identity that any patient is entitled to know.
Question 4 — Lab accreditation and certificate of analysis
The laboratory that processes the cells is the single most under-discussed safety variable in regenerative medicine. The infusion clinic is downstream of the lab — if the lab cuts corners on donor screening, sterility testing, or cell characterization, no amount of clinical skill at the bedside will undo that.
Ask: "Which laboratory processes your cells? Is the lab a member of ISCT (International Society for Cell and Gene Therapy) or ISBT (International Society of Blood Transfusion)? Is it COFEPRIS-registered (Mexico) or FDA-registered (US)? Will you give me a Certificate of Analysis (CoA) for the specific lot I will receive?" The CoA should list cell viability (typically ≥85% post-thaw for MSCs), surface marker characterization (CD90+/CD73+/CD105+ for MSCs, CD45− for absence of hematopoietic contamination), sterility results, endotoxin level, and donor screening summary.
Red flag: "the lab is our own" with no separate accreditation, no ISCT/ISBT membership disclosed, and no CoA available before infusion. A lab that cannot produce a lot-specific CoA is not running a real release-testing program.
Question 5 — Dose disclosure (cells/kg, viability %, route)
Dosing in regenerative medicine is not yet standardized the way pharmacology is for, say, an antibiotic — but a serious clinic still quotes specific, repeatable numbers. The two metrics that matter most are the absolute cell count delivered (typically expressed in millions of cells) and the cells-per-kilogram of patient body weight (a common range for systemic MSC infusion is 1–2 million cells/kg, though indications vary). Viability percentage at time of infusion is the third number — a fresh, well-thawed MSC preparation should be ≥85% viable.
Ask: "How many cells are in my dose? What is the cells-per-kilogram number for my body weight? What is the viability at the time of infusion? What is the route of administration (intravenous, intra-articular, intrathecal, etc.) and the volume? Will this be documented in my chart?" Every number should be in writing before the day of treatment.
Red flag: cell counts that change between quotes, or quotes that talk about "high-dose protocols" without specifying numbers. If the clinic cannot quote viability or cells/kg, the dose is being marketed, not measured.
Question 6 — Clinical evidence for YOUR condition
Mesenchymal stem cell therapy has accumulated a substantial peer-reviewed literature for some indications (osteoarthritis of the knee, certain autoimmune conditions, graft-versus-host disease, ARDS), a modest literature for others, and very little for many of the indications a sales page might promise to treat. The honest answer for any specific patient is conditional on the indication.
Ask: "What is the published evidence for using MSCs in my specific condition? Can you send me three peer-reviewed citations? What is the realistic expected response rate, and what is the realistic non-response rate?" A clinic with a serious medical leadership keeps a citations folder ready and will share it; a sales-led clinic will produce vague "thousands of patients treated" claims with no underlying data.
Red flag: "cure-all" framing where the same protocol treats arthritis, autism, anti-aging, Alzheimer's, and erectile dysfunction. No cellular preparation has equivalent evidence across that range of indications, and a clinic that markets it as if it did is signaling unfamiliarity with the literature.
Question 7 — Honest candidate evaluation
A clinic that has never declined a patient is a clinic with a sales-driven intake, not a medical one. Genuine regenerative medicine has contraindications: active malignancy (or recent history), uncontrolled infection, pregnancy, certain blood disorders, and certain immune-modulating medications can all make a patient temporarily or permanently ineligible. The candidacy decision is medical and should be made by a physician after reviewing the patient's history and recent labs.
Ask: "Have you turned patients away in the last 12 months, and if so, for what reasons? What is your medical-evaluation process? Will I see a physician before I am quoted a price?" An honest clinic will speak openly about the indications they decline. A clinic that says "we treat everyone who applies" is telling you that the medical evaluation is downstream of the sale.
Red flag: a treatment quote arriving before any physician review of records. A protocol that is sold before it is medically indicated is, by definition, not personalized.
Question 8 — Transparent pricing in writing
Pricing in regenerative medicine varies legitimately — protocols differ in cell count, number of sessions, ancillary therapies (IV, hyperbaric, PRP, peptides), and the cost of the supplying lab. What does not vary is the patient's right to a complete, written, all-inclusive quote before any payment, with line items for every cost.
Ask: "Can you send me an itemized written quote, in my preferred language, that lists every cost — consultation, labs, cells, administration, ancillary therapies, follow-up visits, and any unforeseen costs the patient might incur? Is the price all-inclusive or are there add-ons I will be asked to approve once I am there?" A serious clinic provides the quote in writing on the same day. A sales-driven clinic begins with a low number and adds costs after a non-refundable deposit.
Red flag: "limited-time pricing", "if you decide today" discounts, or pressure to lock in a deposit before written documentation arrives. Genuine medical pricing is documented, not auctioned.
Question 9 — Recovery and follow-up protocol
Stem cell therapy is not a one-and-done event — the biological response unfolds over weeks to months. A serious clinic structures recovery and follow-up explicitly: post-infusion instructions (activity restrictions, anti-inflammatory medication management, monitoring), scheduled check-ins at standard intervals (typically 1 month, 3 months, 6 months, and 12 months), and a protocol for repeat dosing if clinically indicated.
Ask: "What does your follow-up program look like? Who manages it after I return home? Can I message a physician or nurse if I have post-treatment questions, and what is the typical response time? Will my outcomes be tracked in writing and shared with me at each check-in?" The follow-up program is where most clinics betray whether they treat patients as one-time customers or long-term medical relationships.
Red flag: "you can call us if you have questions" with no scheduled follow-up calendar, no outcomes tracking, and no defined post-treatment care team. The absence of structure is the structure.
Question 10 — The composite red-flag list
Some warning signs are not single questions but patterns visible across the whole patient experience. If three or more of the following are present, the clinic should be considered a high-risk choice regardless of how attractive the price or the marketing.
No physician names on the website. "Cure-all" claims that treat unrelated conditions with the same protocol. No published outcomes data. Pressure to pay a deposit before a physician consultation. Cell counts and viability not disclosed in writing. No Certificate of Analysis from the supplying lab. No COFEPRIS/FDA/SwissMedic/EMA authorization number. Sales conversations led by non-medical staff over WhatsApp. "Limited-time" pricing tactics. Refusal to put quotes, protocols, or consent forms in writing. Testimonial videos that name no doctors and disclose no outcomes data. A medical director with no public bio or verifiable license.
Each of these alone is a yellow flag. Three or more together is a red flag — meaning a patient walking through the door is statistically more likely to have a bad experience than a good one, regardless of how positive the brochure feels.
How Regeneris answers each of these 10 questions
We hold ourselves to the checklist before we ask any patient to. Here is the short version, with links to the underlying proof pages so you can verify each one independently.
- 1
Regulator
COFEPRIS · Aviso de Funcionamiento 2323025036X00098 · Aviso de Publicidad 2323022002A00053
- 2
Doctors (named, with cédulas)
Dr. Misael González Montenegro · Cédula 13226492. Dra. Marian Tufano · Cédula 12353680. Dra. Claudia Labastida Salazar · Cédula 12128801. Every cédula is verifiable at cedulaprofesional.sep.gob.mx.
- 3
Cell types disclosed
Allogeneic mesenchymal stem cells from umbilical cord tissue (Wharton's jelly), processed at a COFEPRIS-registered laboratory with full donor screening.
- 4
Lab accreditation
Supplying laboratory registered with COFEPRIS; ISCT-aligned characterization protocol (CD90+/CD73+/CD105+, CD45−). Lot-specific Certificate of Analysis available before infusion.
- 5
Dose disclosure
Cell count, cells-per-kg, and post-thaw viability are documented in writing in the medical chart before infusion. Standard adult systemic dose range: 1–2 million cells/kg.
- 6
Clinical evidence
Indication-specific citations folder maintained by the medical team and shared on request. Conditions outside our evidence base are declined or referred elsewhere.
- 7
Honest candidate evaluation
Every patient is reviewed by a physician before a quote is issued. Patients with active malignancy, uncontrolled infection, pregnancy, or certain other contraindications are declined.
- 8
Transparent pricing
Itemized written quote on the same day as your free consultation. All-inclusive structure with no day-of upsells.
- 9
Follow-up protocol
Scheduled check-ins at 1, 3, 6, 12, and 24 months. Direct messaging access to the medical team between visits.
- 10
Red-flag audit
Doctors named publicly. No "cure-all" claims. Outcomes published. No deposits before physician review. CoA provided. COFEPRIS authorizations published. No sales-led WhatsApp protocol quoting.
Take this checklist with you
We deliberately built this page to read like a printable PDF. To save it, use your browser's Print menu and select "Save as PDF" — the layout collapses to a single column with the ten questions, the acceptable-answer language, and the red flags on one document. Bring it to every consultation, including ours. If a clinic objects to you asking these questions, that is itself an answer.
Frequently asked questions
Every legitimate clinic publishes its authorization number on a dedicated regulatory page. In Mexico, that is the COFEPRIS Aviso de Funcionamiento (and Aviso de Publicidad for advertising claims). In the US, the FDA facility registration. You can independently verify Mexican authorizations through gob.mx/cofepris and any cédula profesional at cedulaprofesional.sep.gob.mx. If the clinic refuses to provide the number in writing, treat that as a definitive red flag.
Revisado por Dra. Claudia Labastida Salazar · 2026-05-27
A CoA is the laboratory-issued document that accompanies a specific lot of cellular product. It lists cell viability at thaw, surface marker characterization (CD90+/CD73+/CD105+ for MSCs), sterility test results, endotoxin level, and donor screening summary. Asking for a lot-specific CoA before infusion is the single most reliable way to confirm the lab is running a real release-testing program. A clinic that cannot produce a CoA is either downstream of an under-regulated lab or not actually receiving lot-specific documentation.
Revisado por Dra. Claudia Labastida Salazar · 2026-05-27
No. A medical clinic that will not name the treating physicians in writing is structurally anonymous, which is incompatible with informed consent and with any regulator's expectations. Every cédula in Mexico is a matter of public record — there is no legitimate confidentiality reason to withhold a doctor's name. Anonymity in this context is a warning signal, not a privacy practice.
Revisado por Dra. Claudia Labastida Salazar · 2026-05-27
Ask for three peer-reviewed citations supporting the use of stem cells in your specific condition. A medically-led clinic keeps a citations folder organized by indication and will share it. A sales-led clinic produces "thousands of patients treated" framing with no underlying papers. PubMed (pubmed.ncbi.nlm.nih.gov) and ClinicalTrials.gov are free, and any patient can verify a citation directly. If the cited trials are uncontrolled case series with small numbers, that is a legitimate finding — but it is not the same as a randomized trial, and an honest clinic will say so.
Revisado por Dra. Claudia Labastida Salazar · 2026-05-27
There is no single "fair price" — costs vary legitimately with cell count, number of sessions, indication, and ancillary therapies. The right question is not "how cheap is the protocol?" but "is the price documented, all-inclusive, in writing, before any deposit?" A protocol that is $5,000 with hidden add-ons can be more expensive than a $12,000 all-inclusive program with full follow-up. Compare written quotes side by side, line item by line item.
Revisado por Dra. Claudia Labastida Salazar · 2026-05-27
Yes — though with a caveat. Mesenchymal stem cells have legitimate paracrine and immunomodulatory effects that span several indications (osteoarthritis, autoimmune conditions, certain inflammatory states), so a clinic treating multiple conditions is not inherently suspect. The question is whether the protocol is identical across all indications, or whether dose, route, and follow-up vary by condition based on the underlying biology. A one-size-fits-all protocol that treats arthritis, Alzheimer's, autism, and anti-aging identically is suspect; an indication-specific menu where each condition has a documented evidence base and a tailored protocol is normal.
Revisado por Dra. Claudia Labastida Salazar · 2026-05-27
Information for educational purposes only. This checklist does not constitute medical advice and does not replace evaluation by a licensed physician. Outcomes vary by patient, indication, and prior medical history. Consult our medical team for individualized guidance.