Official Summary Text
This bill authorizes a doctor to perform stem cell therapy that is not approved by the United States food and drug Administration ("FDA") if the therapy is used for treatment or a procedure within the doctor's scope of practice and is related to orthoped
ics, wound care, or pain management. As used in this bill "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, which complies with the regulato
ry
requirements provided in this section, but it explicitly excludes human cells or tissues that were derived from a fetus or an embryo after an abortion.
STANDARDS
In order to ensure the highest standard for the retrieval, manufacture, storage, and use of stem cells, this bill requires that such cells be (i) retrieved, manufactured, and stored in a facility registered and regulated by the FDA; (ii) retrieved, manuf
actured, and stored in a facility certified or accredited by the National Marrow Donor Program, the World Marrow Donor Association, the Association for the Advancement of Blood and Biotherapies, or the American Association of Tissue Banks; and (iii) verif
ie
d to contain viable or live cells using a post-thaw analysis report, which must be sent to the doctor prior to use.
FACILITY CERTIFICATION OR ACCREDITATION
This bill prohibits a doctor from obtaining stem cells for therapy from a facility unless the facility maintains valid certification or accreditation. Any contract for obtaining such cells requires the facility to provide the doctor with its name, addre
ss, accrediting organization, dates of the accreditation, and any contracted limitations. The facility must also notify the doctor within 30 days of any change in accreditation status. When performing a procedure, the doctor must use products from facil
it
ies adhering to current good manufacturing practices pursuant to the federal Food, Drug, and Cosmetic Act.
NOTICE IN ADVERTISEMENT
This bill requires a doctor using stem cell therapy to include a notice in any form of advertisement stating that the doctor performs therapies not yet approved by the FDA. The notice must encourage consultation with a primary care provider, be clearly
legible, and be in a type size no smaller than the largest type size used in the advertisement.
CONSENT
This bill requires a doctor to obtain a signed consent form from the patient or the patient's representative. The form must contain (i) the nature of the proposed treatment; (ii) a statement that the therapy has not been approved by the FDA; (iii) the a
nticipated results of the treatment; and (iv) the recognized risks, complications, anticipated benefits, and possible alternative treatments, including nontreatment.
EXEMPTIONS
This bill does not apply to doctors who have obtained FDA approval for an investigational new drug or device for the use of human cells or tissues. It also does not apply to a doctor performing therapy under a contract for institutions accredited by the
Foundation for the Accreditation of Cellular Therapy, the Blood and Marrow Transplant Clinical Trials Network, the Association for the Advancement of Blood and Biotherapies, or an entity determined by the department to have expertise in stem cell therapy.
VIOLATIONS
This bill provides that a violation may subject the doctor to disciplinary action by the doctor's respective board. Additionally, a doctor commits a Class E felony if the doctor intentionally performs or participates in (i) treatments using human cells o
r tissues derived from a fetus or embryo after an abortion; or (ii) the sale, manufacture, or distribution of computer products created using human cells, tissues, or cellular or tissue-based products. A Class E felony offense is punishable by a term of
im
prisonment of no less than one year nor more than six years and a potential fine not to exceed $3,000.
RULEMAKING
This bill authorizes the board of medical examiners and the board of osteopathic examination to promulgate rules to effectuate this bill.
ON APRIL 13, 2026, THE HOUSE ADOPTED AMENDMENT #1 AND PASSED HOUSE BILL 2246, AS AMENDED.
AMENDMENT #1 rewrites the bill to, instead, authorize a physician to perform stem cell therapy or regenerative medicine therapy that is not approved by the United States food and drug administration (FDA) if such therapy is used for a treatment or proced
ure that is within the scope of practice of the physician. However, a physician who performs stem cell therapy or regenerative medicine must obtain human cells, tissues, or cellular or tissue-based products for the therapy only from a facility that compl
ie
s with this amendment. As used in this amendment, "human cells, tissues, or cellular or tissue-based products" means articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer in
to a human recipient. The term does not include (i) vascularized human organs for transplantation; (ii) ancillary products used in the manufacture of human cells, tissues, or cellular or tissue-based products; (iii) cells, tissues, media, serums, and org
an
s derived from an animal; (iv) in vitro diagnostic products; and (v) blood vessels recovered with an organ that is intended for use in organ transplantation and are clearly labeled as such.
As used in this amendment, "regenerative medicine therapy" means the use of products that are not derived from a fetus or an embryo after an abortion, and that meet all of the following criteria:
•
Products that are supplied by a manufacturer that validates its isolation techniques by including cell viability and surface marker reports for cellular products, a viscosity report for Wharton's jelly, and particle counts for exosome-based regenerative
products.
•
Products that contain a lot-specific sterility report and certificate of analysis for each product before the product is used on a patient.
•
Products that are supplied by a manufacturer that retrieves, manufactures, and stores the product in a facility that is registered with the United States food and drug administration or accredited or certified by a recognized third-party accrediting org
anization including the (i) American Association of Tissue Banks; (ii) American Academy of Stem Cell Medicine; (iii) Association for the Advancement of Blood and Biotherapies; (iv) Foundation for the Accreditation of Cellular Therapy; and (v) World Marrow
D
onor Program.
As used in this amendment, "stem cell therapy" means a treatment involving the use of cellular or tissue-based products that meet all of the following criteria:
•
Products that are retrieved, manufactured, and stored in a facility that provides the physician proof of registration from the FDA for allogeneic therapy or are retrieved, manufactured, and stored in a facility with a Clinical Laboratory Improvement Ame
ndments of 1988 (CLIA) certificate of compliance for autologous therapy.
•
Products that are stored in a freezer that maintains a temperature no higher than negative 80 degrees Celsius, unless the products are for autologous therapy.
•
Products that contain viable or live cells more than 90%, as indicated in a pre-thaw certificate of analysis report, and contain at least 80% viable or live cells, as indicated in a post-thaw viability analysis report for the product lot sent before use
on the patient, unless the products are for autologous therapy.
•
Products that contain documentation that the cellular or tissue-based products meet acceptance criteria established by validated manufacturing procedures, if used for allogeneic therapy, and consistent with applicable regulatory standards before cell ad
ministration, unless the cellular or tissue-based products are used for same-day autologous therapy.
However, this amendment clarifies that stem cell therapy does not include (i) treatment or research using human cells or tissues that were derived from a fetus or an embryo after an abortion; (ii) whole blood, blood components, or blood derivative produc
ts; or (iii) secreted or extracted human products.
ADVERTISING REQUIREMENTS
This amendment requires a physician who conducts stem cell therapy or regenerative medicine therapy to include a specific notice in clearly legible font in a size no smaller than the largest type size used in each advertisement for therapy. The notice m
ust state "THIS NOTICE MUST BE PROVIDED TO YOU UNDER TENNESSEE LAW. This physician performs one (1) or more stem cell or regenerative medicine therapies that have not yet been approved by the United States food and drug administration. You are encourage
d
to consult with your primary care provider before undergoing any stem cell or regenerative medicine therapy."
INFORMED CONSENT
This amendment requires a physician to obtain a written consent form signed by the patient or the patient's representative.
APPLICABILITY
This amendment does not apply to any of the following:
•
A physician who performs therapy approved for an investigational new drug or device by the FDA for the use of human cells, tissues, or cellular tissue-based products.
•
A hospital, affiliated hospital, or outpatient clinic.
•
A therapy performed pursuant to the Phil Timp-Amanda Wilcox Right to Try Act, which authorizes a manufacturer of an investigational drug, biological product, or device to make available such drug, product, or device to eligible patients.
ADVERSE EVENTS
This amendment requires that a physician who performs allogenic stem cell therapy or regenerative medicine therapy pursuant to this amendment to report an adverse event associated with such therapy to the manufacturer and to an accrediting organization w
ithin 30 days. Further, a physician that performs stem cell therapy or regenerative medicine must report an adverse event associated with such therapy to the physician's licensing authority. A physician who performs stem cell therapy or regenerative med
ic
ine is encouraged to participate in clinical outcomes registries maintained by an accredited organization for purposes of ongoing, safety monitoring, quality improvement, and evidence-based practice development. As used in this amendment, "adverse event"
means any untoward medical occurrence associated with the use of stem cell therapy or regenerative medicine therapy, regardless of whether such event is considered related to the therapy, including infection, allergic reaction, disease transmission, or a
n
unanticipated clinical outcome.
RULEMAKING
This amendment authorizes the boards of medical examiners and osteopathic examination to promulgate rules to effectuate this amendment.
Current Bill Text
Read the full stored bill text
HOUSE BILL 2246
By Hurt
SENATE BILL 2586
By Jackson
SB2586
009947
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AN ACT to amend Tennessee Code Annotated, Title 63
and Title 68, relative to stem cell therapies.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
SECTION 1. Tennessee Code Annotated, Title 63, Chapter 6, Part 2, is amended by
adding the following as a new section:
(a) As used in this section:
(1) "Human cells, tissues, or cellular or tissue-based products":
(A) Means articles containing or consisting of human cells or
tissues that are intended for implantation, transplantation, infusion, or
transfer into a human recipient; and
(B) Does not include:
(i) Vascularized human organs for transplantation;
(ii) Whole blood, blood components, or blood derivative
products;
(iii) Secreted or extracted human products, such as milk,
collagen, and cell factors, other than semen;
(iv) Minimally manipulated bone marrow for homologous
use and not combined with another article other than water,
crystalloids, or a sterilizing, preserving, or storage agent, if the
addition of the agent does not raise new clinical safety concerns
with respect to the bone marrow;
(v) Ancillary products used in the manufacture of human
cells, tissues, or cellular or tissue-based products;
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(vi) Cells, tissues, and organs derived from an animal;
(vii) In vitro diagnostic products; and
(viii) Blood vessels recovered with an organ that is
intended for use in organ transplantation and clearly labeled "For
use in organ transplantation only";
(2) "Minimally manipulated" means:
(A) For structural tissue, processing that does not alter the
original relevant characteristics of the tissue relating to the tissue's utility
for reconstruction, repair, or replacement; and
(B) For cells or nonstructural tissues, processing that does not
alter the relevant biological characteristics of cells or tissues;
(3) "Physician" means a person licensed pursuant to chapter 6 or 9 of
this title; and
(4) "Stem cell therapy":
(A) Means a treatment involving the use of afterbirth placental
perinatal stem cells or human cells, tissues, or cellular or tissue-based
products, which complies with the regulatory requirements provided in
this section; and
(B) Does not include treatment or research using human cells or
tissues that were derived from a fetus or an embryo after an abortion.
(b)
(1) A physician may perform stem cell therapy that is not approved by the
United States food and drug administration if the therapy is used for treatment or
a procedure that is within the scope of practice for the physician and the therapy
is related to orthopedics, wound care, or pain management.
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(2) To ensure that the retrieval, manufacture, storage, and use of stem
cells used for stem cell therapy meet the highest standard, stem cells used by a
physician for stem cell therapy must:
(A) Be retrieved, manufactured, and stored in a facility that is
registered and regulated by the United States food and drug
administration;
(B) Be retrieved, manufactured, and stored in a facility that is
certified or accredited by one (1) of the following entities:
(i) National Marrow Donor Program;
(ii) World Marrow Donor Association;
(iii) Association for the Advancement of Blood and
Biotherapies; or
(iv) American Association of Tissue Banks; and
(C) Contain viable or live cells upon post-thaw analysis and be
included in a post-thaw viability analysis report for the product lot which
must be sent to the physician before use with the physician's patient.
(c) A physician performing stem cell therapy shall not obtain stem cells for a
therapy from a facility engaging in the retrieval, manufacture, or storage of stem cells
intended for human use, unless the facility maintains valid certification or accreditation
as required by this section. Any contract or other agreement through which a physician
obtains stem cells for a therapy from such a facility must include the following:
(1) A requirement that the facility provide all of the following information
to the physician:
(A) The name and address of the facility;
(B) The certifying or accrediting organization;
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(C) The type and scope of certification or accreditation;
(D) The effective and expiration dates of the certification or
accreditation; and
(E) Any limitations or conditions imposed by the certifying or
accrediting organization; and
(2) A requirement that the facility notify the physician within thirty (30)
days after a change in certification or accreditation status, including renewal,
suspension, revocation, or expiration.
(d) In the performance of a procedure using or purporting to use stem cells or
products containing stem cells, the physician must use stem cell therapy products
obtained from facilities that adhere to the applicable current good manufacturing
practices for the collection, removal, processing, implantation, and transfer of stem cells,
or products containing stem cells, pursuant to the federal Food, Drug, and Cosmetic Act
(21 U.S.C. § 301 et seq.) and 21 CFR 1271.
(e)
(1) A physician who conducts stem cell therapy pursuant to this section
must include the following in any form of advertisement:
THIS NOTICE MUST BE PROVIDED TO YOU UNDER TENNESSEE
LAW. This physician 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 any
stem cell therapy.
(2) The notice required under subdivision (e)(1) must be clearly legible
and in a type size no smaller than the largest type size used in the
advertisement.
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(f)
(1) A physician who conducts stem cell therapy pursuant to this section
must obtain a signed consent form from the patient before performing the stem
cell therapy.
(2) The signed consent form must be signed by the patient or, if the
patient is not legally competent, the patient's representative and must contain the
following:
(A) The nature and character of the proposed treatment;
(B) A statement that the proposed stem cell therapy has not been
approved by the United States food and drug administration;
(C) The anticipated results of the proposed treatment; and
(D) The recognized serious possible risks, complications, and
anticipated benefits involved in the treatment and the recognized possible
alternative forms of treatment, including nontreatment.
(g) This section does not apply to the following:
(1) A physician 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 physician who performs stem cell therapy under an employment or
other contract on behalf of an institution certified or accredited by any of the
following:
(A) The Foundation for the Accreditation of Cellular Therapy;
(B) The Blood and Marrow Transplant Clinical Trials Network;
(C) The Association for the Advancement of Blood and
Biotherapies; or
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(D) An entity with expertise in stem cell therapy as determined by
the department.
(h) A violation of this section may subject the physician to disciplinary action by
the physician's respective board.
(i) A physician commits a Class E felony who intentionally performs or actively
participates in the following:
(1) Treatment or research using human cells or tissues derived from a
fetus or an embryo after an abortion; or
(2) The sale, manufacture, or distribution of computer products created
using human cells, tissues, or cellular or tissue-based products.
(j)
(1) The board of medical examiners is authorized to promulgate rules
effectuate this section. The rules must be promulgated in accordance with the
Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
(2) The board of osteopathic examination is authorized to promulgate
rules to effectuate this section. The rules must be promulgated in accordance
with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
SECTION 2. For the purposes of promulgating rules, this act takes effect upon
becoming a law, the public welfare requiring it. For all other purposes, this act takes effect July
1, 2026, the public welfare requiring it.