Cellular & biologic therapies
The full picture, before anything is scheduled.
Cellular & biologic therapies at Nuvira are elective, and they are not FDA-approved. This page covers what we review with you first, what treatment day involves, and where the limits are.
Candidacy is decided at consultation. Individual results vary. No outcome is promised.
In plain words
What we mean, and what we leave out
By cellular & biologic therapies, Nuvira means umbilical cord–derived biologic preparations, selected and administered under clinical supervision.
That description is short on purpose. These therapies are not FDA-approved, so we make no claims for them. What is known, and what is not yet known, is reviewed with you directly, before you decide anything.
What we can describe is everything around the therapy: what you are told, who decides, what the day involves and what follows. The rest of this page is about that.
Plainly: these therapies are elective and are not FDA-approved. Candidacy is decided at consultation. Individual results vary, and no outcome is promised.
Before anything is scheduled
Five things we review with you
None of this is held for treatment day. It comes first, while the decision is still entirely open. Your options, the risks, the evidence and the cost go into your written plan.
- 1
Sourcing and handling
Where the preparation comes from, and how it is handled on the way to you. Ask for specifics. It is a fair question to put to any clinic, this one included.
- 2
What is known, and not yet known
The evidence and its limits, in plain language. Where it runs out, we say where. We don't fill the gap with optimism.
- 3
FDA status
These therapies have not been approved by the U.S. Food and Drug Administration. The FDA publishes a list of the cellular and gene therapy products it has approved. None of Nuvira's cellular therapies is on that list.
- 4
The recognized risks
What could go wrong, including the serious possibilities, stated before you decide. If a question about risk has no settled answer yet, you hear that too.
- 5
The alternatives
Including the one that is always available: doing nothing. A plan that never mentions it is not finished.
Then, consent in writing. Before any cellular therapy you'll sign a consent form written in language you can understand. For these therapies, Utah law requires the form to cover the therapy's FDA approval status, the recognized alternatives, and the recognized serious possible risks.
Elective. Not FDA-approved. Candidacy is decided at consultation.
Utah law requires us to give you this notice
THIS NOTICE MUST BE PROVIDED TO YOU UNDER UTAH LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing a stem cell therapy.
Utah Code 58-1-512 · What this notice means
What happens, in order
Treatment day, then the weeks that follow
Here is the order of things, and who to turn to along the way.
- Before the day
No surprises on the day
By treatment day you have the written plan and the cost in writing, and a date and a place have been agreed with you. The consent form is signed before anything is administered. Nothing new is put in front of you on the day, and you can still say no.
- Treatment day
Under clinical supervision
Your clinician comes to the place agreed. The preparation selected for you is administered under clinical supervision, with monitoring. You are given aftercare instructions, and you keep the same point of contact for anything that comes up.
- The weeks after
Support with check-ins
12–16 weeks of support with check-ins. If your plan also includes a peptide program, it sits in the same written plan. Questions go to your one point of contact.
- Around day 90
A scheduled review
Included in every program. We look at where things stand and decide together what, if anything, comes next. “Nothing further” is a perfectly good answer.
There is no trip to plan. We come to you, at a date and a place agreed in advance. Which setting is appropriate is your clinician's call. How visits work
Elective. Not FDA-approved. Candidacy is decided at consultation. Individual results vary, and no outcome is promised.
Honest limits
What we can't tell you
A page like this could make its promises here. We would rather mark where our knowledge, and our role, stops.
- How it will turn out for you. Nobody can promise that honestly, so we don't. These therapies are elective and not FDA-approved. Individual results vary, and no outcome is promised.
- Whether you're a candidate. Not from a web page. Candidacy is decided at consultation by the treating clinician, and the answer can be no.
- That every question is settled. Some aren't. What is not yet known is part of the review, and “we don't know” is an answer you will hear from us.
- That we can stand in for your doctor. We can't. Nuvira is a complement to your own physician, never a replacement. The written plan is yours to share with them.
Questions
Asked plainly, answered plainly
Is this FDA-approved?
No. These therapies are elective and have not been approved by the U.S. Food and Drug Administration. You read that here, you hear it at consultation, and it is in the consent form you sign before any cellular therapy.
Who decides whether I'm a candidate?
The treating clinician, at consultation. Not this page, and not a quiz, so please keep health details out of the website. If a therapy isn't appropriate for you, we'll tell you directly.
Should I talk to my own doctor first?
Yes. Utah's notice encourages you to talk with your primary care provider first. So do we. Go through the written plan with them before you decide.
What does it cost?
Pricing is individualized, so there is no price list to publish. It is discussed at consultation and given to you in writing before anything is scheduled.
The first step
Start with a conversation.
One conversation. No pressure, no pitch. If we're not the right fit, we'll say so.
Elective wellness services. Not FDA-approved to treat any condition. Individual results vary.