Florida Senate - 2025 SB 1768
By Senator Trumbull
2-01302C-25 20251768__
1 A bill to be entitled
2 An act relating to stem cell therapy; creating s.
3 456.63, F.S.; providing legislative findings and
4 intent; defining terms; authorizing health care
5 providers to perform stem cell therapy not approved by
6 the United States Food and Drug Administration under
7 certain circumstances; specifying requirements for the
8 stem cells that may be used by such providers;
9 requiring such providers to adhere to applicable
10 current good manufacturing practices in the
11 performance of such therapies; requiring health care
12 providers to provide a specified written notice to
13 patients before performing any stem cell therapy;
14 specifying requirements for the written notice;
15 providing advertisement requirements; requiring health
16 care providers to obtain written consent from the
17 patient or his or her representative before performing
18 the therapy; specifying requirements for the consent
19 form; providing applicability; providing for
20 disciplinary action; requiring the Department of
21 Health to adopt rules; providing an effective date.
22
23 Be It Enacted by the Legislature of the State of Florida:
24
25 Section 1. Section 456.63, Florida Statutes, is created to
26 read:
27 456.63 Stem cell therapy by health care providers;
28 disclosure; informed consent.—
29 (1) The Legislature recognizes the significant potential of
30 stem cell therapies in advancing medical treatments and
31 improving patient outcomes and further recognizes the need to
32 ensure that such therapies are provided using stem cells
33 obtained in an ethical manner that does not involve stem cells
34 derived from aborted fetuses. It is the intent of the
35 Legislature to foster medical innovation while upholding ethical
36 standards that respect the sanctity of life. By encouraging the
37 use of stem cell sources such as adult stem cells, umbilical
38 cord blood, and other ethically obtained human cells, tissues,
39 or cellular or tissue-based products, the state will advance
40 regenerative medicine in a manner consistent with the values of
41 this state.
42 (2) As used in this section, the term:
43 (a) “Health care provider” means a physician licensed under
44 chapter 458 or an osteopathic physician licensed under chapter
45 459 acting in the course and scope of their employment.
46 (b) “Human cells, tissues, or cellular or tissue-based
47 products” means articles containing or consisting of human cells
48 or tissues collected from cord blood donors who are residents of
49 the United States which are intended for implantation,
50 transplantation, infusion, or transfer into a human recipient,
51 including but not limited to, bones, ligaments, skin, dura
52 mater, heart valves, corneas, hematopoietic stem or progenitor
53 cells derived from peripheral and cord blood, manipulated
54 autologous chondrocytes, epithelial cells on a synthetic matrix,
55 and semen or other reproductive tissue. The term does not
56 include any of the following:
57 1. Vascularized human organs for transplantation.
58 2. Whole blood or blood components or blood derivative
59 products subject to regulation under part I of chapter 499.
60 3. Secreted or extracted human products, such as milk,
61 collagen, and cell factors; except that semen is considered a
62 human cell, tissue, or cellular or tissue-based product for
63 purposes of this paragraph.
64 4. Minimally manipulated bone marrow for homologous use and
65 not combined with another article, except for with water,
66 crystalloids, or a sterilizing, preserving, or storage agent, if
67 the addition of the agent does not raise new clinical safety
68 concerns with respect to the bone marrow.
69 5. Ancillary products used in the manufacture of human
70 cells, tissues, or cellular or tissue-based products.
71 6. Cells, tissues, and organs derived from animals other
72 than humans.
73 7. In vitro diagnostic products.
74 8. Blood vessels recovered with an organ, as defined in 42
75 C.F.R. s. 121.2, which are intended for use in organ
76 transplantation and labeled, “For use in organ transplantation
77 only.”
78 9. Fetal-derived stem cells.
79 10. Adipose-derived mesenchymal stem cells for
80 transplantation.
81 (c) “Minimally manipulated” means:
82 1. For structural tissue, processing that does not alter
83 the original relevant characteristics of the tissue relating to
84 the tissue’s utility for reconstruction, repair, or replacement.
85 2. For cells or nonstructural tissues, processing that does
86 not alter the relevant biological characteristics of cells or
87 tissues.
88 (d) “Stem cell therapy” means a treatment involving the use
89 of human cells, tissues, or cellular or tissue-based products.
90 The term does not include treatment or research using human
91 cells or tissues that were derived from a fetus or an embryo
92 after an abortion.
93 (3)(a) A health care provider licensed in this state may
94 perform stem cell therapy that is not approved by the United
95 States Food and Drug Administration if such therapy is used for
96 treatment or procedures that are within the scope of practice
97 for such provider and the therapies are related to orthopedics,
98 wound care, or pain management.
99 (b) To ensure that the retrieval, manufacture, storage, and
100 use of stem cells used for therapies conducted under this
101 section meet the highest standards, any stem cells used by a
102 health care provider for therapy provided under this section
103 must be:
104 1. Manufactured in a clean room space that has been
105 certified by the United States Food and Drug Administration for
106 using high-efficiency particulate air filtration or ultra-low
107 penetration air filtration to minimize nonviable and viable
108 particulate contamination; and
109 2. Retrieved, manufactured, and stored in a facility that
110 is registered and regulated by the United States Food and Drug
111 Administration and licensed or registered with one of the
112 following entities:
113 a. National Marrow Donor Program.
114 b. World Marrow Donor Association.
115 c. Association for the Advancement of Blood and
116 Biotherapies.
117 d. American Association of Tissue Banks.
118 (4) In the performance of any procedure using or purporting
119 to use stem cells or products containing stem cells, the health
120 care provider shall adhere to the applicable current good
121 manufacturing practices for the collection, removal, processing,
122 implantation, and transfer of stem cells, or products containing
123 stem cells, pursuant to the Federal Food, Drug, and Cosmetic
124 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
125 C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
126 Based Products.
127 (5) A health care provider who conducts stem cell therapy
128 pursuant to this section shall provide a patient who is being
129 treated with stem cell therapy with the following written notice
130 before performing the therapy:
131
132 THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
133 This health care practitioner performs one or more
134 stem cell therapies that have not yet been approved by
135 the United States Food and Drug Administration. You
136 are encouraged to consult with your primary care
137 provider before undergoing any stem cell therapy.
138
139 (6) A health care provider required to provide the written
140 notice under subsection (5) shall:
141 (a) Provide the written notice to a patient on paper that
142 is at least 8.5 inches by 11 inches and printed in no less than
143 40-point type.
144 (b) Prominently display the written notice at the entrance
145 to the health care provider’s office and in an area visible to
146 patients inside such office.
147 (c) Include the notice in any advertisement for the stem
148 cell therapy. In any form of advertisement, the notice must be
149 clearly legible and in a font size no smaller than the largest
150 font size used in the advertisement.
151 (7)(a) A health care provider required to provide the
152 written notice under subsection (5) must obtain a signed consent
153 form from the patient before performing the stem cell therapy.
154 (b) The consent form must be signed by the patient or, if
155 the patient is legally not competent, the patient’s
156 representative and must state all of the following in language
157 the patient or his or her representative could reasonably be
158 expected to understand:
159 1. The nature and character of the proposed treatment,
160 including the treatment’s United States Food and Drug
161 Administration approval status.
162 2. The anticipated results of the proposed treatment.
163 3. The recognized possible alternative forms of treatment.
164 4. The recognized serious possible risks, complications,
165 and anticipated benefits involved in the treatment and in the
166 recognized possible alternative forms of treatment, including
167 nontreatment.
168 (8) This section does not apply to either of the following:
169 (a) A health care provider who has obtained approval for an
170 investigational new drug or device from the United States Food
171 and Drug Administration for the use of human cells, tissues, or
172 cellular or tissue-based products.
173 (b) A health care provider who performs a stem cell therapy
174 under an employment or other contract on behalf of an
175 institution certified by any of the following:
176 1. The Foundation for the Accreditation of Cellular
177 Therapy.
178 2. The Blood and Marrow Transplant Clinical Trials Network.
179 3. The Association for the Advancement of Blood and
180 Biotherapies.
181 4. An entity with expertise in stem cell therapy as
182 determined by the department.
183 (9) A violation of this section may subject the health care
184 provider to disciplinary action under the rules that have been
185 developed by the applicable regulatory board, the department, or
186 the Agency for Health Care Administration, as applicable.
187 (10) The department shall adopt rules to implement this
188 section.
189 Section 2. This act shall take effect July 1, 2025.