The Case for Stem Cell Counselors

•The number of patients enrolled in stem cell clinical trials is growing rapidly•Professionals are needed to explain the risks and benefits of stem cell transplants•A stem cell counseling profession is described•Three major benefits of stem cell counseling for patients are discussed In little more than a decade, stem cell science has moved rapidly from discovery to testing in the clinic. Hundreds of stem cell clinical trials are estimated to be underway for a wide range of conditions (Trounson et al., 2011Trounson A. Thakar R.G. Lomax G. Gibbons D. Clinical trials for stem cell therapies.BMC Med. 2011; 9: 52Crossref PubMed Scopus (339) Google Scholar, Trounson et al., 2012Trounson A. DeWitt N.D. Feigal E.G. The Alpha Stem Cell Clinic: a model for evaluating and delivering stem cell-based therapies.Stem Cells Transl. Med. 2012; 1: 9-14Crossref PubMed Scopus (28) Google Scholar). A 2013 Pharmaceutical Research and Manufacturers of America report lists nearly 80 industry-sponsored cell trials under Food and Drug Administration review; 48 are classified as stem cell trials, and 5 of these are in phase 3 (Pharmaceutical Research and Manufacturers of America, 2013Pharmaceutical Research and Manufacturers of America (2013). Medicines in development: biologics. http://www.phrma.org/sites/default/files/pdf/biologics2013.pdf.Google Scholar). In cardiovascular indications alone, over 100 studies claiming stem cells as a modality are underway (National Institutes of Health, 2014National Institutes of Health (2014). ClinicalTrials.gov: a service of the U.S. National Institutes of Health. https://clinicaltrials.gov.Google Scholar). Dozens of these cardiac trials have already been completed (Zhang et al., 2014Zhang H. Wang H. Li N. Duan C.E. Yang Y.J. Cardiac progenitor/stem cells on myocardial infarction or ischemic heart disease: what we have known from current research.Heart Fail. Rev. 2014; 19: 247-258Crossref PubMed Scopus (8) Google Scholar). This robust translational push equates to thousands of patients enrolled in stem cell trials, and many more thousands of prospective participants inquiring about whether they are eligible for new studies. As a result, Trounson et al., 2012Trounson A. DeWitt N.D. Feigal E.G. The Alpha Stem Cell Clinic: a model for evaluating and delivering stem cell-based therapies.Stem Cells Transl. Med. 2012; 1: 9-14Crossref PubMed Scopus (28) Google Scholar warn that there is an urgent need for professionally trained staff to objectively explain the risks and benefits of stem cell transplants to prospective clinical trial subjects and their families. These trained experts, described here as stem cell counselors, could help potential participants navigate among trials; explain risks, benefits, and therapeutic alternatives; and provide information about unproven transplants offered outside the bounds of clinical research. Stem cell counselors would also work closely with patients enrolled in clinical trials and serve as a public resource for patient education and outreach efforts. This paper describes how a new counseling profession could support clinical sites and patients enrolling in stem cell clinical trials. A model is proposed, along with a curriculum that would provide counselors with the tools to address major issues facing the clinical stem cell field. Finally, a candidate recruitment and clinical site interface scheme is offered. Genetic counseling—which emerged out of advances in human genetics—is a mature and successful example of a client-centered approach to medical care. At its core, genetic counseling provides information and support for people who have or may be at risk for genetic disorders. While genetic counseling began in pediatric/medical genetics and prenatal diagnosis, these professionals now work in many specialty areas, including assisted reproductive technologies, noninvasive prenatal testing, cancer, cord blood banking, cardiology, neurology, psychiatry, metabolic disease, and genomics/personalized medicine (Minkoff and Berkowitz, 2014Minkoff H. Berkowitz R. The case for universal prenatal genetic counseling.Obstet. Gynecol. 2014; 123: 1335-1338Crossref PubMed Scopus (21) Google Scholar, Hendrick and Cobos, 2010Hendrick S.S. Cobos E. Practical model for psychosocial care.J. Oncol. Pract. 2010; 6: 34-36Crossref PubMed Scopus (11) Google Scholar). While these subfields are guided by genetics and heritability, a principle that finds resonance here is the acknowledgment that counseling is a communication process with patient autonomy at its core. Other long-standing precepts include knowledge of science, patient advocacy, respect for the values of patients and families, and teaching and providing information at a level appropriate to the patient’s understanding and interest. Collectively, these activities serve to encourage context-rich, informed patient decisions (National Society of Genetic Counselors, 2014National Society of Genetic Counselors (2014). What is genetic counseling? http://nsgc.org/p/cm/ld/fid=43.Google Scholar). The National Society of Genetic Counselors has recognized the importance of stem cell trials in a recent position statement outlining the different roles that genetic counselors can play in stem cell research, including identifying appropriate research subjects and educating the public (Kirkpatrick et al., 2013Kirkpatrick B. Hercher L. Facio F. Fonda J. Hahn S. Sapp J. Zierhut H. Stem Cell Research Task Force on behalf of the Public Policy CommitteeStem cell research and therapy: the position of the National Society of Genetic Counselors.J. Genet. Couns. 2013; 22: 407-410Crossref PubMed Scopus (5) Google Scholar). However, counselors with rigorous training in stem cell sciences and related ethics, law, and social implications (ELSI) disciplines would provide the greatest benefit for patients and the public. There are several models of genetic counseling that could ably serve patients seeking stem cell transplants. In light of the misinformation and hype surrounding stem cell science, a teaching-based, information-centered method would seem to have clear advantages. However, a strict patient education model may fall short when considering the ethical, social, and political complexities of stem cell clinical trials. Instead, a nondirective, person-centered model—developed by the psychologist Carl Rogers in the 1950s—would value the patient’s belief system, strive to understand the patient’s experiences a larger social context, and empower the patient to make independent, informed definitions free from coercion (Veatch, 2003Veatch P.M. Overview of genetic counseling: history of the profession and methods of practice.in: Veach P.M. LeRoy B.S. Bartels D.M. Facilitating the Genetic Counseling Process. Springer, New York2003: 23-37Google Scholar). Taking this nondirective approach one step further, a biopsychosocial model—first proposed by George Engel—would attend to the biological, psychological, and social dimensions of the illness. Adapted to stem cell trials, this approach would integrate objective biomedical data along with the patient’s subjective experience. In Engel’s scheme, the goal is to transform the patient’s role from a passive recipient of information to one of active, informed choice supported by a caring, empathetic relationship (Engel, 1977Engel G.L. The need for a new medical model: a challenge for biomedicine.Science. 1977; 196: 129-136Crossref PubMed Scopus (7182) Google Scholar, Borrell-Carrió et al., 2004Borrell-Carrió F. Suchman A.L. Epstein R.M. The biopsychosocial model 25 years later: principles, practice, and scientific inquiry.Ann. Fam. Med. 2004; 2: 576-582Crossref PubMed Scopus (773) Google Scholar). With these genetic counseling models in mind, stem cell counselors would offer important advantages to individuals seeking to enroll in trials and assistance to study personnel. They include communicating specialized patient information, guarding against stem cell tourism, and bolstering the process of informed consent and personal autonomy. Stem cell research organizations such as the International Society for Stem Cell Research (ISSCR), the Stem Cell Network of Canada, and the Australian Stem Cell Centre have produced educational materials on websites to help patients understand clinical trials, assess scientific evidence, and identify possible rogue clinics (International Society for Stem Cell Research, 2014International Society for Stem Cell Research (2014). A closer look at stem cell treatments. http://www.closerlookatstemcells.org.Google Scholar, Stem Cell Network of Canada, 2014Stem Cell Network of Canada (2014). What you need to know about stem cell therapies. http://www.stemcellnetwork.ca/index.php?page=patientbooklet&hl=eng.Google Scholar, National Stem Cell Foundation of Australia, 2013National Stem Cell Foundation of Australia (2013). The Australian stem cell handbook: what you should know about stem cell therapies, now and in the future. http://www.stemcellfoundation.net.au/docs/patient-handbook/the-australian-stem-cell-handbook.pdf?sfvrsn=4.Google Scholar). These materials also highlight existing clinical trials and successful research outcomes (Master and Ogbogu, 2012Master Z. Ogbogu U. Stem cell tourism in the era of personalized medicine: what we know, and what we need to know.Curr. Pharmacogenom. Personalized Med. 2012; 10: 106-110Crossref Scopus (8) Google Scholar), but traditional types of patient outreach and education efforts suffer from three limitations. First, the information is often transmitted one way—from experts to patient—without knowing whether it has been effectively communicated or whether it accounts for what patients and families might find most valuable in their decision making. Outreach is most effective when it directly engages individuals and respects values-based opinions and has become an essential part of patient-centered outcomes research (Patient-Centered Outcome Research Institute, 2014Patient-Centered Outcome Research Institute (2014). Patient-Centered Outcomes Research Institute: about us. http://www.pcori.org/about-us.Google Scholar, Lensch, 2011Lensch M.W. Public perception of stem cell and genomics research.Genome Med. 2011; 3: 44Crossref PubMed Scopus (3) Google Scholar, Murdoch and Scott, 2010Murdoch C.E. Scott C.T. Stem cell tourism and the power of hope.Am. J. Bioeth. 2010; 10: 16-23Crossref PubMed Scopus (96) Google Scholar). In addition, these materials encourage patients to consult with their physicians for specific information about preclinical studies, ethical oversight, and possible treatments. Professional responsibilities and legal obligations dictate that physicians must help patients understand this information, yet some physicians may not have the needed expertise—or the time—to offer meaningful recommendations, especially for those unproven stem cell interventions offered outside the bounds of a clinical trial (Levine and Wolf, 2012Levine A.D. Wolf L.E. The roles and responsibilities of physicians in patients’ decisions about unproven stem cell therapies.J. Law Med. Ethics. 2012; 40: 122-134Crossref PubMed Scopus (45) Google Scholar, Zarzeczny and Caulfield, 2010Zarzeczny A. Caulfield T. Stem cell tourism and doctors’ duties to minors—a view from Canada.Am. J. Bioeth. 2010; 10: 3-15Crossref PubMed Scopus (58) Google Scholar). Second, in a fast-moving, fluid field, patient education materials can quickly become outdated. Information may not reflect the most recent clinical or preclinical evidence supporting a study or fully detail the risks and benefits associated with a specialized type of transplant. Finally, materials are often generalized for broad audiences. Here, training in bioethics, regulation, and social implications of stem cell research would enrich communications with a wide variety of patients. Research subjects may have deeply held moral views or have widely varying degrees of technical and scientific understanding. They may need an advocate to help them interpret results, navigate the hospital system, and ensure proper follow-up care. For example, some trials, such as for autism or spinal cord injury, may be conducted in charged and complicated sociopolitical environments. Some patient populations will be more vulnerable than others, and some may have different impressions of risk and benefit (Liu and Scott, 2014Liu E.Y. Scott C.T. Great expectations: autism spectrum disorder and induced pluripotent stem cell technologies.Stem Cell Rep. 2014; 10: 145-150Crossref Scopus (12) Google Scholar, Scott and Magnus, 2014Scott C.T. Magnus D. Wrongful termination: lessons from the Geron clinical trial.Stem Cells Transl. Med. 2014; (Published online October 8, 2014)https://doi.org/10.5966/sctm.2014-0147Crossref PubMed Scopus (41) Google Scholar). Finally, the local context of clinical trials is critical to meet local expectations, as fundamentally different types of relationships exist between patients and researchers (Hunt et al., 2005Hunt L.M. de Voogd K.B. Castañeda H. The routine and the traumatic in prenatal genetic diagnosis: does clinical information inform patient decision-making?.Patient Educ. Couns. 2005; 56: 302-312Abstract Full Text Full Text PDF PubMed Scopus (78) Google Scholar). As specific types of cells are used to treat specific diseases, counseling information will have to be current, accurate, and personalized. As the advent of genetic counseling served to distance human genetics from eugenics, an argument can be made for drawing a sharp boundary between ethical and unethical clinical practice in regenerative medicine (Veatch, 2003Veatch P.M. Overview of genetic counseling: history of the profession and methods of practice.in: Veach P.M. LeRoy B.S. Bartels D.M. Facilitating the Genetic Counseling Process. Springer, New York2003: 23-37Google Scholar). Chief among these is the practice of traveling to receive unproven stem cell interventions, often called stem cell tourism (the common use of the term “stem cell tourism” is not generally preferred, although it continues to be widely used in the literature). This is primarily an Internet-based, direct-to-consumer marketed industry where patients travel to destinations outside their home country to receive untested and unproven clinical stem cell injections (Master and Resnik, 2013Master Z. Resnik D.B. Promoting public trust: ESCROs won’t fix the problem of stem cell tourism.Am. J. Bioeth. 2013; 13: 53-55Crossref PubMed Scopus (4) Google Scholar). One of the hallmarks of stem cell tourism is a form of arbitrage, where a market of clinics and patients—representing supply and demand—are set up along permissive and restrictive regulatory gradients. As a result, clinics unproven are drawing of patients (Trounson et al., 2012Trounson A. DeWitt N.D. Feigal E.G. The Alpha Stem Cell Clinic: a model for evaluating and delivering stem cell-based therapies.Stem Cells Transl. Med. 2012; 1: 9-14Crossref PubMed Scopus (28) Google Scholar). out unproven stem cell interventions is not to varying some clinics in the and outside of In the patients may clinics in or their it to guarding against stem cell tourism, there is little information for potential patients on how the translational process the and of stem cell (Master et al., 2013Master Z. Zarzeczny A. Caulfield T. stem cell translational research in educational information on stem cell Law Med. Ethics. 2013; PubMed Scopus Google Scholar). educational about stem cell clinical and scientific organizations have little information on stem cell the clinical and stem cell (Master et al., Z. D. Caulfield T. Stem cell tourism and public the Stem 2014; Full Text Full Text PDF PubMed Scopus Google Scholar). a for patient from stem cell tourism are and including of public from and to on can from patients home with and or medical information et al., L. J. J. 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