To learn more about regenerative and restorative stem cell therapy treatments, visit stemshealthregenerativemedicine.com or schedule a consultation at our Miami Beach clinic, located at 925 W 41st St #300A, Miami Beach, FL 33140, You can also reach us by phone at (305) 677.0565.
FULL TRANSCRIPT - Guide to Evaluating a Stem Cell Clinic
Welcome to the STEMS Health Regenerative Medicine Podcast.
Today’s episode is a patient-education guide to evaluating a stem cell clinic - focused on due diligence, safety, and informed decision-making.
Stem cell therapy is increasingly discussed as an option in regenerative medicine, especially for joint pain, musculoskeletal injuries, and degenerative conditions. At the same time, clinics offering stem cell-based treatments can vary widely in medical oversight, transparency, and standards of care.
Our purpose today is not to promote treatment or discourage it. The goal is to help patients ask better questions, recognize red flags, and understand what responsible regenerative care should include.
Let’s start with why evaluating a clinic matters.
Stem cell therapy is not a single, standardized treatment. It can involve different cell sources, processing methods, delivery techniques, and regulatory pathways. And for many conditions, applications are still considered investigational.
Because of that, clinics may differ significantly in medical oversight, provider credentials, whether they participate in clinical trials, how they explain evidence, how they handle regulatory disclosures, how they price treatment, and what follow-up care they provide.
These differences directly affect patient safety, expectations, and outcomes. A careful evaluation helps patients distinguish between evidence-informed care and marketing-driven claims.
The first place to start is medical oversight and provider credentials.
A foundational question is simple: who is making the medical decisions?
Stem cell-based care should be overseen by licensed medical providers - typically physicians - who are responsible for evaluating the patient, diagnosing the condition, determining whether regenerative therapy is appropriate, performing or supervising procedures, and managing follow-up care and complications.
As a patient, you should be able to clearly identify the licensed physician directing care, confirm that provider’s state medical license, understand their clinical role and scope of practice, and know who performs evaluations versus who is handling administrative tasks.
Clinics operating primarily as wellness centers or sales organizations - rather than medical practices - may not provide the level of oversight appropriate for biologic therapies.
That leads to an important question: who is actually making clinical decisions?
Patients should clarify whether recommendations come from a licensed physician after an evaluation, or from non-clinical staff following preset protocols.
Red flags include treatment plans presented before medical evaluation, one-size-fits-all protocols applied to all patients, and sales consultations that replace physician visits.
Medical decisions should be made by clinicians, not by marketing or administrative teams.
Next, let’s talk about clinical trials and research context.
Some stem cell clinics participate in registered clinical trials. Others offer treatments that are informed by research but not part of a trial.
These are not the same thing, and clinics should clearly explain the difference.
Clinical trial registration can support transparency, ethical oversight, and defined outcome tracking. But not all legitimate care occurs within a trial setting.
What matters most is honest disclosure of where a treatment falls on the research-to-practice spectrum.
Patients can ask: is the clinic participating in a registered clinical trial? If so, where is it registered - such as ClinicalTrials dot gov? And does the clinic’s description match what the trial listing actually says?
It’s also important to understand that registration does not guarantee effectiveness. It only indicates that the treatment is being studied under defined conditions.
Now let’s address a common language trap: “research-based” versus “research-proven.”
These terms are often used interchangeably, but they mean very different things.
Research-based usually means a treatment is informed by scientific studies - often early-stage studies.
Research-proven suggests consistent clinical evidence and broader acceptance.
A responsible clinic should be willing to explain what level of evidence exists, what is still uncertain, and how that uncertainty is communicated to patients.
Next is published data and evidence transparency.
Not all stem cell applications have extensive published data, especially for emerging uses. That’s not automatically a problem - but how a clinic discusses evidence matters.
Patients should understand the difference between peer-reviewed studies, case reports or observational data, and testimonials or anecdotes.
Testimonials can reflect individual experiences. But they are not scientific evidence.
You don’t need to be a scientist to evaluate evidence more responsibly. You can ask basic questions: was the study peer-reviewed? How many patients were included? Were outcomes measured objectively? And is the condition studied actually similar to yours?
Clinics should be transparent when published data is limited and should avoid overstating conclusions.
Next is regulatory status and legal disclosures.
Many stem cell-based procedures are considered investigational for certain conditions. That does not automatically mean unsafe - but it does mean effectiveness has not been fully established.
Clinics are responsible for explaining whether a treatment is FDA-approved, cleared, or investigational - and what that status means for the patient.
A meaningful disclosure should clearly state the regulatory status, that outcomes cannot be guaranteed, and that research is still evolving.
Caution is warranted if a clinic claims a treatment is “FDA approved” without specifics, uses vague phrases like “FDA compliant” without explaining what that means, or minimizes or avoids discussion of regulatory status altogether.
Now let’s talk about the informed consent process.
Informed consent is not just a form. It’s a process.
Patients should receive enough information to understand what is being offered, what is known and unknown, what alternatives exist, and what risks are possible.
Consent should happen before payment, with time to review and ask questions.
A responsible consent process typically includes potential risks and side effects, the investigational nature of treatment if applicable, alternative treatment options, expected recovery and follow-up, and a clear statement that results are not guaranteed.
Warning signs include pressure to sign the same day, oversimplified consent forms, or language that minimizes uncertainty or risk.
Patients should feel informed - not rushed.
Next is pricing transparency and financial practices.
Stem cell therapy pricing can vary widely based on cell source, processing, delivery method, and follow-up care.
Patients should understand what is included in the quoted price, what may cost extra - like imaging, follow-up visits, or repeat treatments - and the refund, cancellation, or rescheduling policies.
Key questions include: does pricing include evaluation and follow-up care? Are additional treatments expected or optional? And are financing arrangements involved?
Financial red flags include guaranteed results tied to payment, discounts for immediate commitment, or requests for payment before medical evaluation.
Next is follow-up care and outcome monitoring.
Follow-up is a core component of responsible regenerative medicine.
Patients should ask how often follow-up will occur, who to contact with concerns, how outcomes and complications are tracked, and whether licensed providers are available after treatment.
Follow-up care should reasonably include scheduled check-ins, monitoring for side effects or complications, and guidance on activity, rehabilitation, and recovery.
Clinics should also clearly explain how unexpected issues are handled, and how care is coordinated with a patient’s other healthcare providers if needed.
Now let’s address marketing claims and guarantees.
Stem cell therapy involves biologic variability, which means outcomes cannot be guaranteed.
Be cautious of clinics that use words like “cure” or “permanent fix,” apply the same claims to unrelated conditions, or present testimonials as proof.
Clear, educational language is generally a sign of transparency. Absolute claims are not.
So here’s a practical due-diligence checklist.
Before choosing a stem cell clinic, consider whether it provides licensed medical oversight, clear explanation of cell source and handling, honest discussion of evidence and uncertainty, regulatory and investigational disclosures, meaningful informed consent, transparent pricing, and a defined follow-up care plan.
The big takeaway is this.
Stem cell therapy should be approached as a medical process - not a consumer product. Details matter: evaluation, sourcing, handling, delivery, and follow-up.
This guide is meant to support thoughtful conversations with licensed providers and help patients make decisions grounded in evidence, transparency, and individual suitability.
Before we close, a brief disclaimer.
The information provided in this episode is for educational and informational purposes only and is not intended as medical advice. Treatments and outcomes described may not be appropriate for every individual. Always consult a licensed healthcare provider to determine the best course of care for your specific needs.
Certain regenerative medicine procedures discussed - such as stem cell therapy, exosome therapy, or other biologic treatments - may be considered investigational or not FDA-approved for all conditions. Florida law requires disclosure of this status. While these procedures may be offered in accordance with state and federal guidelines, their safety and efficacy have not been fully established by the U.S. Food and Drug Administration.
Results vary, and no guarantee of outcome is implied. All medical procedures involve potential risks, which should be discussed with your provider prior to treatment.
Thanks for listening to the STEMS Health Regenerative Medicine Podcast.
We’ll see you next time.
