Our standards, in writing.
What we require of every product we supply, every clinic in our network, and ourselves.
Every product
Product standards
What every product supplied through RegenerateLife must come with before it reaches a clinic.
Processed by an FDA-registered U.S. laboratory
Registration is a facility requirement. It is not FDA approval of any product.
Donor screening and infectious-disease testing
Documented for every donation before processing.
A Certificate of Analysis for every lot
Release testing results, shipped with the product.
Cold-chain shipping
Cryopreserved, with temperature records for the journey.
Traceability from donor to clinic
Lot records that let a clinic, or a regulator, trace any vial.
Recall and adverse-event procedure
A written process and a line to report a problem the same day.
Every partner clinic
Partner clinic standards
What a clinic must meet, and keep meeting, to be introduced to patients through RegenerateLife.
Licensed providers and a named medical director
Licenses verified before a clinic joins and reviewed regularly.
Practice within scope and state law
Each clinic attests to compliance with the laws where it practices.
Written informed consent
Including the product’s regulatory status, risks and alternatives.
Correct storage, thawing and handling
With lot records kept for every product used.
Adverse-event reporting and complaints
Reported promptly, and a clear way for patients to raise concerns.
Written prices, no pressure
A price in writing before any decision, and no high-pressure tactics.
Ourselves
Our own standards
The rules RegenerateLife holds itself to, as a navigator and a supplier.
No medical advice from navigators
Navigators inform and connect. Clinicians advise.
No fees to patients, no per-referral fees
We are paid as a supplier, never per patient introduced.
No paid or invented reviews
We do not publish testimonials we cannot stand behind.
Privacy first
Details shared with a clinic only with your permission, and never sold.
Honest about regulatory status
We say plainly what is and is not FDA-approved.
Standards reviewed
We review these standards, and our partners, on a regular schedule.
Regulatory status
No fine print on the hard part.
The stem cell, Muse cell and exosome products referenced on this site are not approved by the FDA to diagnose, treat or prevent any disease. “FDA-registered” describes the laboratory’s facility registration only.
Products are supplied only to verified, licensed healthcare providers, who are responsible for deciding whether and how a product is used, within their scope of practice and the laws that apply to them.
Questions about our standards?
Ask a care navigator, or, if you run a licensed practice, ask our partner desk.