- Protect your practice.
- Support your patients.
- Prove your credibility — without adding to your workload.
Meet Regulatory Expectations
Regenerative and cellular therapies are under more regulatory and public scrutiny than ever. State expectations around informed consent and adverse event tracking are rising, and providers offering therapies outside FDA-approved indications are increasingly expected to show organized, documented oversight — not an ad hoc approach.
R3 Stem Cell Research now gives you a straightforward way to meet that moment: the first IRB-approved, multi-site, international observational safety database built specifically for regenerative therapies. Your patients still receive their procedures exactly as they do today, on an out-of-pocket basis — the only difference is the structured, documented framework now standing behind every case.
Ready to Join?
Find out today if your practice qualifies to participate in R3 Stem Cell Research’s IRB-approved observational safety database — the only study of its kind. Contact us for a brief conversation.
How It Works
We evaluate whether your practice is a fit, and if so, our research team handles the heavy lifting from there — informed consent, structured follow-up, and adverse event tracking are all managed by R3, not added to your staff’s plate.
- Approved consent and follow-up forms — prepared and provided by our team
- Ongoing patient check-ins on a regular, structured basis — patients consistently tell us they appreciate it
- Rapid notification to your practice if any concern arises
- Your procedures and pricing stay exactly the same — patients still receive care as usual, out of pocket
R3 Research Publications
Ready to Join?
Find out today if your practice qualifies to participate in R3 Stem Cell Research’s IRB-approved observational safety database — the only study of its kind. Contact us for a brief conversation.
FAQS
R3 Stem Cell Research — Frequently Asked Questions
What is the R3 Stem Cell Research observational safety database?
It’s an IRB-approved, multi-site, international observational study (Protocol R3-GOSD-001) built specifically for regenerative and cellular therapy providers. It gives participating practices a structured, documented framework for informed consent, patient follow-up, and adverse event tracking, and contributes de-identified data to a broader multi-national safety dataset and publication program.
What does "IRB-approved" actually mean here?
An Institutional Review Board has reviewed and approved the study protocol, consent materials, and data collection procedures to ensure they meet accepted standards for observational human-subjects research. IRB oversight is a formal, ongoing layer of review — not a one-time approval — and provides documented, third-party evidence that patient safety monitoring is being handled systematically.
Does joining change how I treat patients or what I charge?
No. Procedures, clinical decision-making, and pricing all stay exactly as they are today, and patients continue to receive care on an out-of-pocket basis. Participation adds a documented research and safety-monitoring layer behind the care you’re already providing — it does not change the care itself.
What does R3 handle versus what does my practice handle?
R3’s research team prepares and provides the approved consent and follow-up forms, manages structured patient check-ins, and handles adverse event tracking and rapid notification back to your practice if a concern arises. Your staff isn’t asked to take on additional administrative work to participate.
Which practices should prioritize joining?
Any regenerative medicine practice can apply, but participation is especially relevant for practices in states where IRB oversight or documented adverse event reporting is becoming a statutory or regulatory expectation, since it gives those practices a ready-made, third-party-reviewed framework to point to.
Does participation mean my treatments are FDA-approved?
No. As noted in our site disclaimer, stem cell therapy is regulated by the FDA but is not FDA-approved, and it’s considered experimental. Participation in this observational safety database does not change that regulatory status — it provides a documented oversight and monitoring framework around procedures that remain investigational and out-of-pocket.
What happens if an adverse event is reported?
R3’s research team tracks adverse events as part of the structured follow-up process and rapidly notifies your practice if a concern arises, so you can respond promptly and the event is captured as part of the documented safety record.
How is patient data collected and protected?
Data collection follows the IRB-approved protocol, with patient consent obtained using the approved forms R3 provides. Business associate agreements and structured data-handling procedures are part of the program’s infrastructure, and patient information contributes to the aggregate, multi-site safety dataset rather than being shared individually outside that framework.
Can my practice contribute to publications or research findings?
Yes. Participating practices have access to opportunities connected to the multi-national safety dataset and R3’s peer-reviewed publication program, alongside the broader body of regenerative medicine research R3 shares publicly.
What does it cost to participate, and how do I get started?
Costs and specific requirements depend on your practice and location, since not every site will be the same fit. The first step is a brief conversation with R3 Stem Cell Research to see whether your practice qualifies to participate.
Disclaimer: Stem cell therapy is considered experimental and is regulated by the U.S. Food and Drug Administration (FDA), but it is not FDA-approved. No statements here have been evaluated or approved by the FDA. This content is for informational purposes only and is not medical advice.
Contact us
Find out today if your practice qualifies to participate in R3 Stem Cell Research’s IRB-approved observational safety database — the only study of its kind. Contact us for a brief conversation.
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