A5464

An Act concerning stem cell therapy and supplementing Title 45 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. a. The Legislature finds and declares that there is significant potential of stem cell therapies in advancing medical treatments and improving patient outcomes, and further recognizes the need to ensure that such therapies are provided using stem cells obtained in an ethical manner that does not involve stem cells derived from aborted fetuses. It is the intent of the Legislature to foster medical innovation, while upholding ethical standards that respect the sanctity of life. By encouraging the use of stem cell sources such as adult stem cells, umbilical cord blood, and other ethically obtained human cells, tissues, or cellular or tissue-based products, the State will advance regenerative medicine in a manner consistent with the values of this State.

b. As used in this section:

“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 into a human recipient. The term does not include: vascularized human organs for transplantation; whole blood, blood components, or blood derivative products; secreted or extracted human products, such as milk, collagen, and cell factors, other than semen; 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; ancillary products used in the manufacture of human cells, tissues, or

cellular or tissue-based products; cells, tissues, and organs derived from animals other than humans; in vitro diagnostic products; or blood vessels recovered with an organ which are intended for use in

organ transplantation and labeled “For use in organ transplantation only.”

“Minimally manipulated” means: 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 for replacement or for cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.

“Physician” means an individual licensed to practice medicine and surgery in this State.

“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 regulatory requirements provided in this section. The term shall not include treatment or research using human cells or tissues that were derived from a fetus or an embryo after an abortion.

c. (1) A physician may perform stem cell therapy that is not approved by the United States Food and Drug Administration, if such therapy is used for treatment or procedures that are within the scope of practice for the physician and the therapies are related to orthopedics, wound care, or pain management.

(2) Any stem cells used by a physician for therapy provided under

this section shall:

(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 of the following entities: 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;

(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 shall be sent to the physician before use with the physician’s patient.

(3) A physician performing stem cell therapy pursuant to this section may not obtain stem cells for therapies from a facility engaging in the retrieval, manufacture, or storage of stem cells intended for human use under this section, unless the facility maintains valid certification or accreditation as required by this paragraph. Any contract or other agreement by which a physician obtains stem cells for therapies from such a facility shall include the following:

(a) a requirement that the facility provide all of the following information to the physician: the name and address of the facility; the type and scope of certification or accreditation and the certifying or accrediting organization; the effective and expiration dates of the certification or accreditation; and any limitations or conditions imposed by the certifying or accrediting organization; and

(b) a requirement that the facility notify the physician within 30 days after any change in certification or accreditation status, including renewal, suspension, revocation, or expiration.

(4) In the performance of any procedure using or purporting to use stem cells or products containing stem cells, the physician shall 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. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21 C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products.

(5) (a) A physician who conducts stem cell therapy pursuant to this section shall include the following in any form of advertisement related to the provision of stem cell therapy:

THIS NOTICE MUST BE PROVIDED TO YOU UNDER NEW JERSEY 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.

(b) The notice required under subparagraph (a) of this paragraph must be clearly legible and in a type size no smaller than the largest type size used in the advertisement.

(6) (a) A physician who conducts stem cell therapy pursuant to this section shall obtain a signed consent form from the patient before

performing the stem cell therapy.

(b) The consent form must be signed by the patient or, if the patient is not legally competent, the patient’s representative and shall state the following in a language the patient or the patient’s representative may reasonably be expected to understand:

(i) the nature and character of the proposed treatment;

(ii) that the proposed stem cell therapy has not yet been approved by the United States Food and Drug Administration;

(iii) the anticipated results of the proposed treatment;

(iv) the recognized serious possible risks, complications, and anticipated benefits involved in the treatment and in the recognized possible alternative forms of treatment, including nontreatment; and

(v) that the patient is encouraged to consult with the patient’s primary care provider before undergoing any stem cell therapy.

(7) The provisions of this section shall not apply to:

(a) 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

(b) 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: 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 with expertise in stem cell therapy as determined by the Department of Health

(8) A violation of this section may subject the physician to disciplinary action by the State Board of Medical Examiners.

(9) A physician who willfully performs, or actively participates in, the following commits a crime of the third degree:

(a) treatment or research using human cells or tissues derived from a fetus or an embryo after an abortion; or

(b) the sale, manufacture, or distribution of computer products created using human cells, tissues, or cellular or tissue-based products.

2. The State Board of Medical Examiners shall adopt rules and regulations, pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), as may be necessary to implement the provisions of this act.

3. This act shall take effect immediately.

STATEMENT

This bill permits physicians to provide certain stem cell therapy under certain circumstances.

Under the bill, a physician may perform stem cell therapy that is not approved by the United States Food and Drug Administration, if such therapy is used for treatment or procedures that are within the scope of practice for the physician and the therapies are related to orthopedics, wound care, or pain management. The bill requires that any stem cells used by a physician for therapy provided under the bill will: be retrieved, manufactured, and stored in a facility that is registered and regulated by the United States Food and Drug Administration; be retrieved, manufactured, and stored in a facility with certain certifications or accreditations; and contain viable or live cells upon post-thaw analysis and be included in a post-thaw viability analysis report.

Under the bill, a physician performing stem cell therapy may not obtain stem cells for therapies 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.

In the performance of any procedure using or purporting to use stem cells or products containing stem cells, the physician will use stem cell therapy products obtained from facilities that adhere to the applicable current good manufacturing practices.

The bill requires a physician who conducts stem cell therapy pursuant to this section to include a certain notice to patients in advertisements. A physician who conducts stem cell therapy pursuant to this section is required to obtain a signed consent form from the patient before performing the stem cell therapy.

A violation of the bill’s provisions may subject the physician to disciplinary action by the State Board of Medical Examiners. The bill provides that a physician who willfully performs, or actively participates in, the following commits a crime of the third degree: treatment or research using human cells or tissues derived from a fetus or an embryo after an abortion; or the sale, manufacture, or distribution of computer products created using human cells, tissues, or cellular or tissue-based products. The bill exempts certain physicians from the provisions of the bill.