Rescuing human fetal tissue research in the United States: A call for additional regulatory reform.
Ontology highlight
ABSTRACT:
SUBMITTER: MacDuffie KE
PROVIDER: S-EPMC8693650 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:: Colorectal cancer has the second highest cancer-related mortality rate, with an estimated 881,000 deaths worldwide in 2018. The urgent need to reduce the incidence and mortality rate requires innovative strategies to improve prevention, early diagnosis, prognostic biomarkers, and treatment effectiveness. Caloric restriction (CR) is known as the most robust nutritional intervention that extends lifespan and delays the progression of age-related diseases, with remarkable results for cancer protection. Other forms of energy restriction, such as periodic fasting, intermittent fasting, or fasting-mimicking diets, with or without reduction of total calorie intake, recapitulate the effects of chronic CR and confer a wide range of beneficial effects towards health and survival, including anti-cancer properties. In this review, the known molecular, cellular, and organismal effects of energy restriction in oncology will be discussed. Energy-restriction-based strategies implemented in colorectal models and clinical trials will be also revised. While energy restriction constitutes a promising intervention for the prevention and treatment of several malignant neoplasms, further investigations are essential to dissect the interplay between fundamental aspects of energy intake, such as feeding patterns, fasting length, or diet composition, with all of them influencing health and disease or cancer effects. Currently, effectiveness, safety, and practicability of different forms of fasting to fight cancer, particularly colorectal cancer, should still be contemplated with caution.
| S-EPMC7019819 | biostudies-literature
Project description:Islet allotransplantation in the United States (US) is facing an imminent demise. Despite nearly three decades of progress in the field, an archaic regulatory framework has stymied US clinical practice. Current regulations do not reflect the state-of-the-art in clinical or technical practices. In the US, islets are considered biologic drugs and "more than minimally manipulated" human cell and tissue products (HCT/Ps). In contrast, across the world, human islets are appropriately defined as "minimally manipulated tissue" and not regulated as a drug, which has led to islet allotransplantation (allo-ITx) becoming a standard-of-care procedure for selected patients with type 1 diabetes mellitus. This regulatory distinction impedes patient access to islets for transplantation in the US. As a result only 11 patients underwent allo-ITx in the US between 2016 and 2019, and all as investigational procedures in the settings of a clinical trials. Herein, we describe the current regulations pertaining to islet transplantation in the United States. We explore the progress which has been made in the field and demonstrate why the regulatory framework must be updated to both better reflect our current clinical practice and to deal with upcoming challenges. We propose specific updates to current regulations which are required for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States.
| S-EPMC8016716 | biostudies-literature
Project description:Interprofessional education (IPE) and collaborative practice (CP) have been prolific areas of inquiry exploring research questions mostly concerned with local program and project assessment. The actual sphere of influence of this research has been limited. Often discussed separately, this article places IPE and CP in the same conceptual space. The interface of these form a nexus where new knowledge creation may be facilitated. Rigorous research on IPE in relation to CP that is relevant to and framed by health system reform in the U.S. is the ultimate research goal of the National Center for Interprofessional Practice and Education at the University of Minnesota. This paper describes the direction and scope for a focused and purposive IPECP research agenda linked to improvement in health outcomes, contextualized by health care reform in the U.S. that has provided a revitalizing energy for this area of inquiry. A research agenda articulates a focus, meaningful and robust questions, and a theory of change within which intervention outcomes are examined. Further, a research agenda identifies the practices the area of inquiry is interested in informing, and the types of study designs and analytic approaches amenable to carrying out the proposed work.
| S-EPMC4776700 | biostudies-other
Project description:Background and objectives: Peritoneal dialysis (PD) for ESKD is associated with similar mortality, higher quality of life, and lower costs compared with hemodialysis (HD), but has historically been underused. We assessed the effect of the 2011 Medicare prospective payment system (PPS) for dialysis on PD initiation, modality switches, and stable PD use.Design, setting, participants, & measurements: Using US Renal Data System and Medicare data, we identified all United States patients with ESKD initiating dialysis before (2006-2010) and after (2011-2013) PPS implementation, and observed their modality for up to 2 years after dialysis initiation. Using logistic regression models, we examined the associations between PPS and early PD experience (any PD 1-90 days after initiation), late PD use (any PD 91-730 days after initiation), and modality switches (PD-to-HD or HD-to-PD 91-730 days after initiation). We adjusted for patient, dialysis facility, and regional characteristics.Results: Overall, 619,126 patients with incident ESKD received dialysis at Medicare-certified facilities, 2006-2013. Observed early PD experience increased from 9.4% before PPS to 12.6% after PPS. Observed late PD use increased from 12.1% to 16.1%. In adjusted analyses, PPS was associated with increased early PD experience (odds ratio [OR], 1.51; 95% confidence interval [95% CI], 1.47 to 1.55; P<0.001) and late PD use (OR, 1.47; 95% CI, 1.45 to 1.50; P<0.001). In subgroup analyses, late PD use increased in part due to an increase in HD-to-PD switches among those without early PD experience (OR, 1.59; 95% CI, 1.52 to 1.66; P<0.001) and a decrease in PD-to-HD switches among those with early PD experience (OR, 0.92; 95% CI, 0.87 to 0.98; P=0.004).Conclusions: More patients started, stayed on, and switched to PD after dialysis payment reform. This occurred without a substantial increase in transfers to HD.
| S-EPMC6895485 | biostudies-literature
Project description:Background and objectivesSarcomas represent a heterogeneous group of tumors, and there is lack of data describing contemporary changes in patterns of care. We evaluated the epidemiology of sarcomas over 12 recent years.MethodsThe Surveillance, Epidemiology and End Results (SEER) database was queried for sarcoma cases from 2002-2014. Patient, tumor and treatment factors, and trends over time were studied overall and by subtype. Univariable and multivariable logistic regression models and 5-year survival and cause-specific mortality (CSM) were summarized.ResultsThere were 78,527 cases of sarcomas with an overall incidence of 7.1 cases per 100,000 people, increasing from 6.8 in 2002 to 7.7 in 2014. Sarcoma NOS(14.8%) and soft tissue(43.4%) were the most common histology and primary site, respectively. A majority of tumors were high-grade(33.6%) and >5 cm(51.3%). CSM was 28.6% and 5-year survival was 71.4%. Many patients had unknown-grade(42.2%), which associated with 2.6 times increased odds of no surgical intervention.ConclusionsThis comprehensive national study highlights important trends including increasing incidence, changing histologic types, and underestimation of true incidence. A large proportion of sarcomas are inadequately staged (unknown-grade 42.2%) with lack of appropriate surgical treatment. Our study highlights need for standardization of care for sarcomas.
| S-EPMC6497437 | biostudies-literature
Project description: Not available
| S-EPMC6467299 | biostudies-literature
Project description:Online hemodiafiltration provides greater removal of higher molecular weight uremic retention solutes than conventional high-flux hemodialysis. However, online hemodiafiltration is used sparsely in the United States in part because of a paucity of delivery systems cleared for clinical use by the US Food and Drug Administration. Although a pathway for regulatory approval exists in the United States, concerns remain, particularly regarding online production of the large volumes of sterile, nonpyrogenic substitution fluid infused directly into the bloodstream to maintain fluid balance. Clearly defined testing protocols, acceptable to Food and Drug Administration, will be useful to show that an online hemodiafiltration system is capable of routinely achieving a sterility assurance level of 10-6 and nonpyrogenic levels of endotoxin. Large-scale clinical experience has shown that systems providing this level of performance when combined with certain design features, such as redundancy, and an appropriate quality management process can routinely and safely produce substitution fluid for online hemodiafiltration.
| S-EPMC6140579 | biostudies-literature
Project description:Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European Union (EU), and Japan. In this study, the definition, legislation, and approval system of these products were surveyed. A total of nine autologous human cells and tissue products approved until October 2013 were collected. The definitions of human cells and tissue products were compatible among the US, the EU and Japan. The products were classified as human cells, tissue, and cellular and tissue-based products (HCT/Ps) in the US, advanced therapy medicinal products (ATMPs) in the EU, and cell/tissue-engineered products in Japan. These products were categorized as biologics and medical device in the US and Japan, and drug in the EU. The issuance of new guidance induced regulatory impact for manufacturer, especially in the US. These products are subjected to the accelerated approval of biological product, the humanitarian device exemption approval, the premarket application approval, the biologics license application approval, and new drug application approval with specific targeting of postapproval registry or surveillance. Of nine autologous human cells and tissue products, four products had been evaluated using clinical experiences or open clinical trials with small subjects, although the rests of products had been evaluated using comparative clinical trials with control treatment. Our survey suggests that autologous human cells and tissue products would need postmarket-oriented evaluation rather than premarket-oriented evaluation for doctors and patients.
| S-EPMC6581762 | biostudies-literature
Project description:Access to paid family and medical leave ("paid leave") has bipartisan support among lawmakers in the United States, but the issue remains stalled on the public policy agenda. The U.S. does not currently have a federal paid leave policy, and unpaid leave-guaranteed by the Family and Medical Leave Act of 1993-is all that is available to the majority of workers. In this study, we examine the content of local television news as representations of, and potential influence on, paid leave policy agendas. To do so, we analyze the extent to which local television news coverage describes the problem of lack of employment leave, and whether coverage highlights public policy as a solution. We use data from local television stations affiliated with the four major networks (ABC, NBC, CBS, and FOX) in all 210 media markets in the U.S. during a period pre-pandemic, from October 2018 until July 2019. We find that 64% of local television news coverage related to paid leave discussed the issue in the context of public policy. Coverage more often cited early-stage policy actions such as a policy idea - reflected in 40% of stories discussing stages of public policymaking - or the introduction of a bill - detailed in 22% of these stories. This coverage aligns with actual policy activity at the state-level during the same time period. News coverage infrequently included elements that could shape public understanding of paid leave as a population health issue, such as including health-related sources of providers or researchers. Policymakers, advocates, and researchers looking to advance public support for paid leave should consider efforts to use local television news as a vehicle to present health and policy-relevant information to broad segments of the public and set the agenda for policy reform.
| S-EPMC8164082 | biostudies-literature
Project description:In the burn treatment landscape, a variety of skin substitutes, human tissue-sourced products, and other products are being developed based on tissue engineering (ie, the combination of scaffolds, cells, and biologically active molecules into functional tissue with the goal of restoring, maintaining, or improving damaged tissue or whole organs) to provide dermal replacement, prevent infection, or prevent or mitigate scarring. Skin substitutes can have a variety of compositions (cellular vs acellular), origins (human, animal, or synthetically derived), and complexities (dermal or epidermal only vs composite). The regulation of tissue-engineered products in the United States occurs by one of several pathways established by the U.S. Food and Drug Administration, including a Biologics License Application (BLA), a 510(k) (Class I and Class II devices), Premarket Approval (Class III devices), or a human cells, tissues, and cellular and tissue-based products designation. Key differentiators among these regulatory classifications include the amount and type of data required to support a filing. For example, a BLA requires a clinical trial(s) and evaluation of safety and efficacy by the Center for Biologics Evaluation and Research. Applicable approved biological products must also comply with submission of advertising and promotional materials per regulations. This review provides a description of, and associated requirements for, the various regulatory pathways for the approval or clearance of tissue-engineered products. Some of the regulatory challenges for commercialization of such products for the treatment of burns will be explored.
| S-EPMC8335953 | biostudies-literature