38-1,147.

Stem-cell-based therapy; informed written consent; required.

(1) For purposes of this section:

(a) Health care practitioner means a person licensed or certified under the Uniform Credentialing Act;

(b) Human stem cells means human cells, tissues, or cellular or tissue-based products, as defined in 21 C.F.R. 1271.3 as amended August 31, 2016, as published in the Federal Register at 81 Fed. Reg. 60223;

(c) Informed written consent related to stem-cell-based therapy means a signed writing executed by a patient that confirms that (i) a health care practitioner has explained the treatment, (ii) the treatment has not received the approval of the United States Food and Drug Administration, including for experimental use, and (iii) the patient understands that the treatment has not received such approval; and

(d) Stem-cell-based therapy means treatment using products derived from human stem cells.

(2) Any health care practitioner who performs stem-cell-based therapy shall, by informed written consent, communicate to any patient seeking stem-cell-based therapy from such practitioner that it is not approved by the United States Food and Drug Administration.

(3) This section does not apply to a health care practitioner using stem-cell-based therapy products that are approved by the United States Food and Drug Administration or stem-cell-based therapy for which the health care practitioner obtained approval for an investigational new drug or device from the United States Food and Drug Administration for use of human cells, tissues, or cellular or tissue-based products.