Novel, experimental, and unproven stem cell and regenerative therapies should be used only when traditional or accepted treatment has been exhausted, a new report says.
In addition, physicians should be prepared to use documented evidence to support claims about the benefits of stem cell treatments.
Those are among the recommendations a national workgroup on regenerative and stem cell therapy practices published earlier this year, to provide basic guidance for state medical boards, and licensed physicians and physician assistants. (Advanced practice registered nurses are licensed by state nursing boards and for that reason are not specifically included in the report.)
The recommendations address the regulation of stem cell and regenerative therapies, how physicians should communicate and promote them to patients, and how doctors should document treatments provided.
The workgroup, part of the Federation of State Medical Boards, convened in May of 2017, and its report was adopted as federation policy in April.
The study hits amid growing interest and controversy over state “right-to-try” laws giving patients with certain debilitating illnesses access to experimental treatments, including stem cell use.
The report “aims to raise awareness about regenerative and stem cell therapy practices generally … and outline their potential benefits and risks,” the workgroup said. “Central to all of the recommendations … is a range of imperatives, including the importance of protecting the public, respecting patient autonomy, preventing patient exploitation, obtaining informed consent, and appropriately documenting care that is recommended and provided.”
The workgroup consisted of physicians and subject matter experts from around the United States.
Its report makes 11 recommendations for state medical boards and individual physicians regarding stem cell therapy. Among them:
- State medical boards should make licensees aware of federal and state legislation and regulations, including pending or existing “right to try” legislation;
- Physicians must offer treatments only to patients with whom they have a bona fide physician-patient relationship;
- Physicians should refrain from charging excessive fees for treatments, and they should not make intentional misrepresentations to increase the level of payment they receive; and
- Physicians should consult and educate patients about stem cell interventions and alert them to important resources available to the community.
Although most clinics that provide stem cell interventions are located outside of North America, more and more are opening in the U.S. The report identified 351 businesses with more than 570 clinics in the U.S. that market stem cell interventions directly to consumers.
As part of their marketing practices, some clinics use what the study group called “tokens of scientific legitimacy” to support their treatments or the quality of a clinic and its employees, such as mentioning affiliations with a professional society or network, or claims of partnerships with academic institutions.
The Texas Legislature last year passed House Bill 810 that expands Texas’ right-to-try laws, allowing patients with chronic and terminal illnesses access to experimental stem cell interventions in the state. The Texas Medical Board and the Texas Department of State Health Services have adopted rules to implement the law.
The Texas Medical Association stayed neutral on the bill and the rules.
As part of its official policy, TMA “supports biomedical research on multipotent stem cells (including embryonic, adult, and cord blood stem cells), … opposes the use of somatic cell nuclear transfer technology for the specific purpose of producing a human child (reproductive cloning), [and] encourages strong public support of federal funding for research involving human pluripotent stem cells.”