Legal Disclosure — Utah Code § 58-1-512

Stem Cell Therapy
Legal Disclosure & Notices

Required under Utah State Law. Please read carefully before undergoing stem cell therapy at Joint Regeneration Center of Utah.

Back to Stem Cell Therapy

Mandatory Utah Law Notice

The following notice is required by Utah Code § 58-1-512 and must be provided to every patient before stem cell therapy is performed. It is also displayed prominently in 40-point type at the entrance of our clinic.

 Required Notice — Utah Law

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.

What Are the Stem Cells We Use?

At Joint Regeneration Center of Utah, "stem cells" refers specifically to postnatal, human mesenchymal stem cells (MSCs) — cells that remain in the umbilical cord and placenta after a healthy live birth by local Utah mothers.

These stem cells ARE:

  • Postnatal, afterbirth placental and umbilical cord-derived cells from healthy, live Caesarian births
  • First-generation, growth factor-containing cells purified from umbilical cord blood
  • Specialized human "signaling" cells that contain growth factors and cytokines involved in human growth and development
  • Carefully isolated, processed, and tested for contaminants
  • Authorized for use under Utah State Law (Utah Code § 58-1-512)

These stem cells ARE NOT:

  • Not embryonic stem cells
  • Not lab-grown stem cells
  • Not derived from aborted fetal tissue
  • Not your own body's aging stem cells
  • Not FDA-approved for the treatment of joint conditions

What Stem Cells Are NOT Designed To Do

  • Stem cell therapy is not designed to have stem cells attach and grow into new tissue, cartilage, muscle, skin, or neurons
  • Stem cells are not programmed to become new tissue, cartilage, muscles, skin, or neurons
  • We cannot guarantee any specific outcome — every body responds differently
  • These treatments are not FDA-approved for joint conditions

What Stem Cells ARE Known To Do

  • Deliver growth factors and protein molecules to the site of your injury or inflammation
  • Move to sites of inflammation or tissue injury and secrete growth factors (trophic agents)
  • Release cytokines (immunomodulatory agents) that help control the immune response
  • Support the body's natural healing process in a positive, beneficial way

Research shows that stem cells move to sites of inflammation or tissue injury and secrete growth factors and cytokines — immune system modulators that help control the immune system and immune response. Growth factors are signaling molecules that control cell division, growth, and repair. Cytokines are signaling proteins that help control inflammation in your body. Every body is different; we cannot guarantee any specific outcomes.

FDA Status & Legal Authorization

Stem cell therapy for joint conditions has not been approved by the FDA. Utah State Law specifically authorizes licensed health care providers to perform these therapies provided that required patient disclosures are made.

Joint Regeneration Center of Utah performs stem cell therapies authorized by Utah Code § 58-1-512 — even though they have not yet been approved by the FDA. The FDA has approved stem cell therapy for certain other conditions (such as cancer patients after chemotherapy and long-COVID patients with lung damage) which have been shown to be safe and effective in those contexts. The FDA continues to review stem cell therapies broadly.

Safety

Stem cell injections of this type have been performed safely for decades. Our products are sourced from healthy, screened Utah donors, carefully processed, and tested for contaminants. Our clinic and supplier have no reported adverse events. As with any therapeutic procedure, individual risk exists — your body might have a unique allergy or reaction. If you experience any adverse event following your procedure, please notify us immediately at (801) 996-3592.

Informed Consent — What You Will Sign

Before undergoing stem cell therapy, Utah Code § 58-1-512(4) requires you to sign an informed consent form covering the following in plain language:

A
Nature & Character of Treatment A description of the proposed stem cell therapy, including its FDA approval status — specifically, that it is not yet FDA-approved for this use.
B
Anticipated Results A realistic explanation of expected results, including that individual results vary and no specific outcome can be guaranteed.
C
Alternative Forms of Treatment Information about recognized alternative treatments available for your condition.
D
Risks, Complications & Benefits The recognized serious possible risks, complications, and anticipated benefits of stem cell therapy and of alternatives — including the option of no treatment at all.

The form must be signed before any stem cell therapy is performed. If you are not legally competent to sign, your legal representative may sign on your behalf per Utah Code § 58-1-512(4)(b)(i).

Frequently Asked Questions

Is this legal — are you allowed to offer stem cell therapy?

Yes. Our clinic performs stem cell therapies authorized under Utah Code § 58-1-512, even though they have not yet received FDA approval. Utah law specifically permits licensed health care providers to perform these therapies as long as required disclosures are provided to patients beforehand.

If it's not FDA-approved, is it safe?

The FDA has not approved these stem cells for joint conditions — but that does not mean the procedure is unsafe. Stem cell injections of this type have been performed safely for decades. Our products are sourced from healthy, screened Utah donors, carefully processed, and tested for contaminants. Our clinic and supplier have zero reported adverse events. As with any procedure, some individual risk exists.

Will stem cells heal, re-grow, or regenerate my tissue?

These stem cells are not designed to attach and grow into new tissue, cartilage, muscles, or neurons, and are not programmed to become new tissue. What they do is deliver growth factors and protein molecules to the site of your injury. Research shows stem cells move to sites of inflammation and secrete growth factors and cytokines that help modulate the immune response and support the body's natural healing process. We cannot guarantee any specific outcome — every body is different.

Where do the stem cells come from?

The stem cells we use are postnatal mesenchymal stem cells from the umbilical cord and placenta after a healthy, live Caesarian birth by local Utah mothers. They are not embryonic, not lab-grown, not from aborted tissue, and not your own aging cells. They are first-generation, growth factor-containing cells that carry the cytokines naturally involved in human growth and development.

What types of stem cell injections do you offer?

For qualifying patients, we offer stem cell injections into joints (knee, ankle, shoulder, elbow, wrist, knuckle) or near the spine, discs, or vertebrae. Depending on your consultation and clinical assessment, stem cells may also be administered beneath the surface of the skin or into muscle tissue. All administration methods are determined on a case-by-case basis by your provider.

Should I consult my primary care provider first?

Utah law encourages you to consult with your primary care provider before undergoing stem cell therapy. We also encourage you to ask us any questions — call (801) 996-3592 or email hello@regenerationutah.com.

Utah Code § 58-1-512 — Full Text

The complete text of the Utah law governing stem cell therapy disclosure requirements, effective May 1, 2024.

 Utah Code § 58-1-512 — Effective 5/1/2024

58-1-512. Stem cell disclosure.

(1) As used in this section:

  1. "Health care provider" means the same as that term is defined in Section 78B-3-403.
  2. "Human cells, tissues, or cellular or tissue-based products" has the same meaning as in 21 C.F.R. Sec. 1271.3 as it exists on May 1, 2024.
  3. "Stem cell therapy" means a treatment involving the use of afterbirth placental perinatal stem cells or human cells, tissues, or cellular or tissue-based products.
    1. "Stem cell therapy" does not include treatment or research using human cells or tissues that were derived from a fetus or embryo after an abortion.

(2) A health care provider whose scope of practice includes the use of stem cell therapy may perform a stem cell therapy that is not approved by the United States Food and Drug Administration, if the health care provider provides the patient with the following written notice before performing the therapy:

"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."

(3)

  1. The written notice described in Subsection (2) shall be:
    1. on paper that is at least eight and one-half inches by eleven inches; and
    2. written in no less than forty point type.
  2. The health care provider shall prominently display the written notice in the entrance and in an area visible to patients in the health care provider's office.

(4)

  1. A health care provider who is required to provide written notice under Subsection (2) shall obtain a signed consent form before performing the therapy.
  2. The consent form shall:
    1. be signed by the patient, or, if the patient is legally not competent, the patient's representative; and
    2. state, in language the patient could reasonably be expected to understand:
      1. the nature and character of the proposed treatment, including the treatment's United States Food and Drug Administration approval status;
      2. the anticipated results of the proposed treatment;
      3. the recognized possible alternative forms of treatment; and
      4. the recognized serious possible risks, complications, and anticipated benefits involved in the treatment and in the recognized possible alternative forms of treatment, including nontreatment.

(5)

  1. A health care provider described in Subsection (2) shall include the notice described in Subsection (2) in any advertisement for the stem cell therapy.
  2. In a print advertisement, the notice shall be clearly legible, in a font size no smaller than the largest font size used in the advertisement.
  3. In any other advertisement, the notice shall be:
    1. clearly legible in a font size no smaller than the largest font size used in the advertisement; or
    2. clearly spoken.

(6) This section does not apply to:

  1. a health care provider who has obtained approval for an investigational new drug or device from the United States Food and Drug Administration for the use of human cells, tissues, or cellular or tissue-based products; or
  2. a health care provider who performs stem cell therapy under an employment or other contract on behalf of an institution certified by any of the following:
    1. the Foundation for the Accreditation of Cellular Therapy;
    2. the Blood and Marrow Transplant Clinical Trials Network;
    3. the Association for the Advancement of Blood and Biotherapies; or
    4. an entity with expertise regarding stem cell therapy as determined by the division.

(7) A violation of this section is unprofessional conduct.

Questions?

If you have questions about this disclosure, the stem cell therapy we offer, your consent form, or your rights as a patient, please contact us before proceeding with any treatment.

(801) 996-3592 hello@regenerationutah.com Contact Page