Stem cells, cell therapies, and bioengineering in lung biology and disease 2021.

The 9th biennial conference titled "Stem Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases" was hosted virtually, due to the ongoing COVID-19 pandemic, in collaboration with the University of Vermont Larner College of Medicine, the National Heart, Lung, and Blood Institute, the Alpha-1 Foundation, the Cystic Fibrosis Foundation, and the International Society for Cell & Gene Therapy. The event was held from July 12th through 15th, 2021 with a pre-conference workshop held on July 9th. As in previous years, the objectives remained to review and discuss the status of active research areas involving stem cells (SCs), cellular therapeutics, and bioengineering as they relate to the human lung. Topics included 1) technological advancements in the in situ analysis of lung tissues, 2) new insights into stem cell signaling and plasticity in lung remodeling and regeneration, 3) the impact of extracellular matrix in stem cell regulation and airway engineering in lung regeneration, 4) differentiating and delivering stem cell therapeutics to the lung, 5) regeneration in response to viral infection, and 6) ethical development of cell-based treatments for lung diseases. This selection of topics represents some of the most dynamic and current research areas in lung biology. The virtual workshop included active discussion on state-of-the-art methods relating to the core features of the 2021 conference, including in situ proteomics, lung-on-chip, induced pluripotent stem cell (iPSC)-airway differentiation, and light sheet microscopy. The conference concluded with an open discussion to suggest funding priorities and recommendations for future research directions in basic and translational lung biology.

The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions.

In March 2021, 1,480 U.S. businesses operating 2,754 clinics were found selling purported stem cell treatments for various indications. More than four times as many businesses than were identified 5 years ago are selling stem cell products that are not FDA-approved and lack convincing evidence of safety and efficacy.

Ethical issues and public communication in the development of cell-based treatments for COVID-19: Lessons from the pandemic.

The significant morbidity and mortality of coronavirus disease 19 (COVID-19) prompted a global race to develop new therapies. These include interventions using cell- or cell-derived products, several of which are being tested in well-designed, properly controlled clinical trials. Yet, the search for cell-based COVID-19 treatments has also been fraught with hyperbolic claims; flouting of crucial regulatory, scientific, and ethical norms; and distorted communication of research findings. In this paper, we critically examine ethical issues and public communication challenges related to the development of cell-based therapeutics for COVID-19. Drawing on the lessons learned from this ongoing process, we argue against the rushed development of cell-based interventions. We conclude by outlining ways to improve the ethical conduct of cell-based clinical investigations and public communication of therapeutic claims.

Crowdfunding, stem cell interventions and autism spectrum disorder: comparing campaigns related to an international "stem cell clinic" and US academic medical center.

BACKGROUND AIMS: Studies examining crowdfunding campaigns for stem cell interventions have typically focused on campaigns seeking funds to send individuals to businesses marketing unlicensed and unproven stem cell products. However, some crowdfunding campaigns identify academic medical centers as destinations for individuals seeking access to stem cell products provided either in clinical studies or on an expanded access basis. This study examines crowdfunding campaigns seeking funds to enable children diagnosed with autism spectrum disorder access to stem cell interventions. METHODS: This study compares and contrasts crowdfunding campaigns, identifying an international stem cell clinic marketing a purported umbilical cord blood-derived stem cell treatment for autism spectrum disorder, with campaigns soliciting donations intended to help children with autism spectrum disorder either participate in clinical studies or obtain expanded access to stem cell products provided at an academic medical center in the US. RESULTS: Campaigns connected to both sites contained inaccurate claims. However, campaigns identifying the international clinic as the intended destination site made stronger claims about efficacy and were more reliant upon testimonials than campaigns listing the US-based academic medical center as the planned clinical site. Acknowledging these important distinctions, clinical studies and press releases associated with the academic medical center played an important role in lending the perception of credibility to the putative stem cell treatments marketed by the international clinic. CONCLUSIONS: The study's findings emphasize how important it is for researchers at academic medical centers and comparable research facilities to avoid engaging in stem cell hyperbole; highlight the preliminary nature of early clinical studies; ensure that any claims about safety and efficacy are based upon robust and reliable evidence; and promote responsible science communication by exercising restraint when crafting press releases, conducting media interviews and otherwise publicizing clinical research findings.

Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed "Stem Cell Treatments" for COVID-19.

In the midst of a global public health emergency, some businesses are taking advantage of widespread fears by marketing purported stem cell treatments for COVID-19. Such businesses target prospective clients with misleading claims, expose patients to potentially risky stem cell-based products, and undermine efforts to develop evidence-based treatments for COVID-19.

Translating Basic Research into Safe and Effective Cell-based Treatments for Respiratory Diseases.

Respiratory diseases, such as chronic obstructive pulmonary disease and pulmonary fibrosis, result in severely impaired quality of life and impose significant burdens on healthcare systems worldwide. Current disease management involves pharmacologic interventions, oxygen administration, reduction of infections, and lung transplantation in advanced disease stages. An increasing understanding of mechanisms of respiratory epithelial and pulmonary vascular endothelial maintenance and repair and the underlying stem/progenitor cell populations, including but not limited to airway basal cells and type II alveolar epithelial cells, has opened the possibility of cell replacement-based regenerative approaches for treatment of lung diseases. Further potential for personalized therapies, including in vitro drug screening, has been underscored by the recent derivation of various lung epithelial, endothelial, and immune cell types from human induced pluripotent stem cells. In parallel, immunomodulatory treatments using allogeneic or autologous mesenchymal stromal cells have shown a good safety profile in clinical investigations for acute inflammatory conditions, such as acute respiratory distress syndrome and septic shock. However, as yet, no cell-based therapy has been shown to be both safe and effective for any lung disease. Despite the investigational status of cell-based interventions for lung diseases, businesses that market unproven, unlicensed and potentially harmful cell-based interventions for respiratory diseases have proliferated in the United States and worldwide. The current status of various cell-based regenerative approaches for lung disease as well as the effect of the regulatory environment on clinical translation of such approaches are presented and critically discussed in this review.

The politics of evidence in online illness narratives: An analysis of crowdfunding for purported stem cell treatments.

This article addresses the growing trend of crowdfunding for unproven stem cell-based treatments. Our analysis uses quantitative and qualitative data collected from two popular fundraising sites to examine how these sites are used to fund purported stem cell 'treatments' or 'therapies'. In addition to mapping the use and success of these online campaigns by people with different health conditions in different locations, we consider the breakthrough restitution story as a key narrative that campaign organisers use to solicit donations. We argue that crowdfunding is a rapidly growing digital space where 'truths' about experimental treatments are constituted and a politics of evidence is unfolding. These developments are to the potential financial benefit of crowdfunding platforms and businesses offering unproven stem cell-based interventions, and to the potential detriment of patients and their supporters.

Direct-to-consumer marketing of stem cell interventions by Canadian businesses.

AIM: This study examines marketing claims of Canadian businesses engaged in direct-to-consumer advertising of putative stem cell treatments. METHODS: Internet searches were used to locate Canadian businesses selling stem cell interventions. Company websites were subjected to detailed analysis. RESULTS: In total, 30 Canadian businesses sell stem cell interventions provided at 43 clinics. Autologous stem cells are the most common types of products promoted by such businesses. Company websites minimize risks while making strong claims about benefits of stem cell interventions. DISCUSSION: Businesses' representations could result in patients making health-related decisions informed by marketing claims rather than best available scientific evidence. CONCLUSION: Although there is absent development of new regulations and guidance, the Canadian direct-to-consumer marketplace for stem cell interventions appears poised for expansion.

Selling stem cell 'treatments' as research: prospective customer perspectives from crowdfunding campaigns.

AIM: To better understand how prospective customers interpret claims of businesses marketing unproven stem cell products that they are engaging in research activities. MATERIALS & METHODS: The authors examined 408 crowdfunding campaigns for unproven stem cell interventions for references to research activities. RESULTS: The authors identified three overarching themes: research as a signifier of scientific credibility; the experimental nature of stem cells as a rationale for noncoverage by insurers; and contributing to the advancement of science by engaging in research. CONCLUSION: The NIH, US FDA and others should be concerned about being co-opted to misrepresent the nature of these businesses' activities. Efforts are also needed to better inform those considering purchasing unproven stem cell interventions about their relationship to legitimate research.

The US Direct-to-Consumer Marketplace for Autologous Stem Cell Interventions.

Hundreds of businesses and clinics in the United States are engaged in direct-to-consumer marketing of unproven and unlicensed stem cell-based interventions. This essay provides an overview of this marketplace, examines advertising techniques companies use to draw clients and legitimate marketing claims, and summarizes the roles the Food and Drug Administration (FDA) and other agencies are supposed to play in regulating the direct-to-consumer marketplace for stem cell interventions. The essay also reviews federal regulations, describes how many businesses selling purported "stem cell treatments" appear to violate these standards, and considers ethical issues and harms associated with widespread promotion of unapproved stem cell products.

Medical societies, patient education initiatives, public debate and marketing of unproven stem cell interventions.

Businesses marketing unproven stem cell interventions proliferate within the U.S. and in the larger global marketplace. There have been global efforts by scientists, patient advocacy groups, bioethicists, and public policy experts to counteract the uncontrolled and premature commercialization of stem cell interventions. In this commentary, we posit that medical societies and associations of health care professionals have a particular responsibility to be an active partner in such efforts. We review the role medical societies can and should play in this area through patient advocacy and awareness initiatives.

ClinicalTrials.gov, stem cells and 'pay-to-participate' clinical studies.

Numerous US businesses that engage in direct-to-consumer advertising of stem cell interventions that are not US FDA-approved also recruit clients by listing 'pay-to-participate' studies listed on ClinicalTrials.gov . Individuals considering enrolling in such studies and NIH officials responsible for overseeing the database need to be aware that some businesses are using the registry to promote unapproved stem cell interventions that study subjects are charged to receive. Inclusion of such studies in ClinicalTrials.gov reveals that the database needs better screening tools. In particular, screening should evaluate whether studies submitted to the registry have been reviewed and permitted to proceed by the FDA in the case of clinical studies requiring FDA clearance in addition to institutional review board approval.

"Ensure that you are well aware of the risks you are taking ": actions and activities medical tourists' informal caregivers can undertake to protect their health and safety.

BACKGROUND: When seeking care at international hospitals and clinics, medical tourists are often accompanied by family members, friends, or other caregivers. Such caregiver-companions assume a variety of roles and responsibilities and typically offer physical assistance, provide emotional support, and aid in decision-making and record keeping as medical tourists navigate unfamiliar environments. While traveling abroad, medical tourists' caregiver-companions can find themselves confronted with challenging communication barriers, financial pressures, emotional strain, and unsafe environments. METHODS: To better understand what actions and activities medical tourists' informal caregivers can undertake to protect their health and safety, 20 interviews were conducted with Canadians who had experienced accompanying a medical tourist to an international health care facility for surgery. Interview transcripts were subsequently used to identify inductive and deductive themes central to the advice research participants offered to prospective caregiver-companions. RESULTS: Advice offered to future caregiver-companions spanned the following actions and activities to protect health and safety: become an informed health care consumer; assess and avoid exposure to identifiable risks; anticipate the care needs of medical tourists and thereby attempt to guard against caregiver burden; become familiar with important logistics related to travel and anticipated recovery timelines; and take practical measures to protect one's own health. CONCLUSION: Given that a key feature of public health is to use research findings to develop interventions and policies intended to promote health and reduce risks to individuals and populations, the paper draws upon major points of advice offered by study participants to take the first steps toward the development of an informational intervention designed specifically for the health and safety needs of medical tourists' caregiver companions. While additional research is required to finalize the content and form of such an intervention, this study provides insight into what practical advice former caregiver-companions state should be shared with individuals considering assuming these roles and responsibilities in the future. In addition, this research draws attention to the importance of ensuring that such an intervention is web-based and readily accessible by prospective caregiver-companions.

US stem cell clinics, patient safety, and the FDA.

Scholarship on patients accessing unproven stem cell interventions is dominated by research addressing 'stem cell tourism' to such countries as China, India, Mexico, and the Ukraine. However, clinics marketing 'adipose-derived mesenchymal stem cell treatments' are proliferating across the USA. These businesses typically claim to operate in compliance with federal regulations, but careful review of their commercial practices suggests that such clinics are marketing unapproved and noncompliant biological drugs.