Provider Challenge Sheet
Twelve questions to bring into the room.
Print this. Bring it to the consult. A vague answer is still an answer.
Print · Bring · Ask
Use this sheet after the score reveal. Ask every question in order and document vague answers in writing.
1
What is the exact name of the product you propose to administer, and who is the manufacturer?
Good AnswerSpecific product name, trade name, cell type, and named manufacturer with a verifiable public presence. Offered without hesitation.
Bad Answer"Stem cells," "regenerative therapy," "our proprietary formula," vague source description without a manufacturer name, or "we make it ourselves" without GMP documentation offered.
2
Can I see the Certificate of Analysis for the specific lot to be administered to me?
Good AnswerYes, here it is — with lot number, viability percentage, sterility result, endotoxin result, and release date. Or: I will have it to you before your procedure date.
Bad Answer"Patients don't receive COAs," "it's proprietary," "we test everything in-house," or simply changing the subject. A COA is a standard document. Its absence means there is no verifiable quality control.
3
Is this therapy FDA-approved for my specific condition? If not, is it part of a registered clinical trial?
Good AnswerYes, FDA-approved — here is the BLA number. Or: No, it is experimental — here is the NCT number for the registered trial, and here is the informed consent form that explains the risks and your rights as a research participant. You will not be charged for trial participation.
Bad Answer"FDA registered" (registration ≠ approval), "FDA compliant," "we follow FDA guidelines," charging for trial participation, or "the FDA doesn't approve things like this because of big pharma."
4
What peer-reviewed clinical trial evidence exists for this specific cell type and this specific condition?
Good AnswerA specific journal citation with a DOI or NCT number, published in a peer-reviewed journal, for your condition and this cell type — not animal studies, not general MSC research, not case reports.
Bad AnswerPatient testimonials, before/after photos, "we have over X successful patients," general claims about stem cell potential, animal study citations, or mechanism explanations without human trial data.
5
What baseline measurements will you take before treatment, and how will you define success?
Good AnswerSpecific validated measurement instruments (VAS pain scale, WOMAC for orthopedic, specific imaging or lab values), a defined threshold for what counts as improvement, and a structured follow-up timeline with defined checkpoint dates.
Bad Answer"You'll feel the difference," "most patients report improvement," "we track everything," vague quality-of-life language with no defined scale, or no mention of baseline measurement at all.
6
How is the product shipped and stored — what is the cold chain protocol?
Good AnswerSpecific temperature requirements, temperature-monitoring system during transit, maximum transport time, storage conditions at the clinic, and what happens if a temperature excursion occurs before administration.
Bad Answer"We handle it," "it's very stable," "our supplier takes care of that," or simply no information offered. Cellular products are alive. Temperature excursions can kill them or compromise sterility without any visible sign.
7
What is the route of administration, and will image guidance be used?
Good AnswerSpecific route named (intra-articular, intrathecal, intramuscular, etc.) with a clear biological rationale for why that route makes sense for your condition. Image guidance confirmed for any structural or targeted injection.
Bad AnswerIV administration for an orthopedic or structural condition (cells administered IV do not home to specific joints), no image guidance mentioned for structural procedures, or route described vaguely as "injection."
8
What is the adverse event protocol — what happens if something goes wrong during or after treatment?
Good AnswerNamed emergency contact, hospital transfer arrangement or affiliation, written adverse event protocol provided in advance, and clarity on who manages care if a complication arises at home after you've left the facility.
Bad Answer"The only risk is it doesn't work," "it's completely safe," "we've never had a problem," or no mention of an adverse event protocol. Every biologic has a risk profile. Claiming zero risk reflects ignorance or dishonesty.
9
If treatment is abroad: what is my recourse if something goes wrong, and what does my insurance cover?
Good AnswerClear explanation of the malpractice framework in the destination country, confirmation of what your travel insurance covers (or honest acknowledgment that it probably doesn't cover unapproved biologics), and a plan for managing complications at home after return.
Bad AnswerNo discussion of legal recourse, assumption that your insurance covers experimental procedures abroad, no home physician follow-up arranged, or dismissal of the question as hypothetical.
10
Can you provide references to patients I can speak with — and your documented outcomes data?
Good AnswerWillingness to connect you with former patients (with their consent), access to aggregate outcomes data including both positive and negative results, and transparency about the range of outcomes rather than curated success stories only.
Bad AnswerTestimonials only, video testimonials only, refusal to share data ("confidential"), or data that shows only successful outcomes with no adverse events or non-responders. No medical intervention works for everyone. A 100% success rate is a claim, not data.
11
Have you asked for full payment before providing any documentation?
Good AnswerNo. All documentation — COA, procedure plan, adverse event protocol, informed consent — is provided before any financial commitment. A small scheduling deposit is standard. Full payment before documentation is not.
Bad AnswerFull payment or a large deposit is required before the COA, procedure plan, or adverse event protocol are provided. This pattern has been documented in FDA warning letters against specific stem cell clinics. It is a consumer fraud signal, not a business policy quirk.
12
Is anyone pressuring me to decide quickly?
Good AnswerNo. The provider has given you time to review documentation, consult your home physician, seek a second opinion, and decide without urgency. You have been explicitly told there is no deadline.
Bad Answer"This offer expires Friday," "we only have one slot left," "the price increases next week," "you really should start treatment as soon as possible." ISSCR explicitly states that patients should not be rushed or financially incentivized to make treatment decisions. Any urgency pressure is a reason to slow down, not speed up.