FDA regulation of adult stem cell therapies as used in sports medicine.

In sports medicine, adult stem cells are the subject of great interest. Several uses of stem cells are under investigation including cartilage repair, meniscal regeneration, anterior cruciate ligament reconstruction, and tendinopathy. Extensive clinical and basic science research is warranted as stem cell therapies become increasingly common in clinical practice. In the United States, the Food and Drug Administration (FDA) is responsible for regulating the use of stem cells through its "Human Cells, Tissues, and Cellular and Tissue-Based Products" regulations. This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented that highlight how stem cells are currently being used in sports medicine and how current FDA regulations are likely to affect the physicians who use them. In the process, it explains how a variety of factors in sourcing and handling these cells, particularly the extent of cell manipulation, will affect what a physician can and cannot do without first obtaining the FDA's express approval.

European definitions, current use, and EMA stance of platelet-rich plasma in sports medicine.

Platelet-rich plasma has been the focus of much attention over the last few years as an appealing biological approach to favor the healing of tissues otherwise doomed by a low healing potential. In Europe, the regulatory framework concerning the blood system is currently disciplined by Directive 2002/98/EC of the European Parliament and Council of January 27, 2003, which sets out quality and safety rules for collecting, controlling, processing, preserving, and distributing human blood and its components, acknowledged in the various States of the Union with internal regulations. This lack of homogeneity in the European legal landscape will probably lead the Community legislature to intervene in the near future, to even out the "rules of engagement" of this peculiar class of biomaterials.

US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine.

With increased utilization of platelet-rich plasma (PRP), it is important for clinicians to understand the United States, the Food and Drug Administration (FDA) regulatory role and stance on PRP. Blood products such as PRP fall under the prevue of FDA's Center for Biologics Evaluation and Research (CBER). CBER is responsible for regulating human cells, tissues, and cellular and tissue-based products. The regulatory process for these products is described in the FDA's 21 CFR 1271 of the Code of Regulations. Under these regulations, certain products including blood products such as PRP are exempt and therefore do not follow the FDA's traditional regulatory pathway that includes animal studies and clinical trials. The 510(k) application is the pathway used to bring PRP preparation systems to the market. The 510(k) application allows devices that are "substantially equivalent" to a currently marketed device to come to the market. There are numerous PRP preparation systems on the market today with FDA clearance; however, nearly all of these systems have 510(k) clearance for producing platelet-rich preparations intended to be used to mix with bone graft materials to enhance bone graft handling properties in orthopedic practices. The use of PRP outside this setting, for example, an office injection, would be considered "off label." Clinicians are free to use a product off-label as long as certain responsibilities are met. Per CBER, when the intent is the practice of medicine, clinicians "have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects." Finally, despite PRP being exempted, the language in 21 CFR 1271 has caused some recent concern over activated PRP; however to date, the FDA has not attempted to regulate activated PRP. Clinicians using activated PRP should be mindful of these concerns and continued to stay informed.

Cardiac evaluation of collegiate student athletes: a medical and legal perspective.

Physicians participate in the screening, routine medical supervision, and disqualification process of collegiate student athletes today. Physicians and universities evaluating collegiate student athletes for athletic participation should understand the meticulous medical process necessary to make eligibility/disqualification decisions and the associated liability issues. It is the responsibility of a team physician to take the lead role in the college sports medical evaluation process. The first duty of a team physician and institution is to protect the health and well-being of their collegiate student athletes. The potential liability associated with the evaluation process requires institutions of higher education and physicians to develop sound and reasonable administrative strategies regarding college athletes and their participation in intercollegiate athletics. Reducing this liability risk requires an understanding of the evolving judicial framework and compliance with standard case law and available guidelines. As medical professional standards evolve, so will responsibilities under legal standards.

[Sudden cardiac death in athletes is usually caused by undiagnosed heart disease. Cardiac screening of young athletes under discussion]. / Plötslig hjärtdöd hos idrottare beror oftast på odiagnostiserad hjärtsjukdom. Kardiell screening av unga idrottare diskuteras.

Sudden death during exercise in young athletes is usually caused by previously undiagnosed heart disease. The most frequent underlying diseases are hypertrophic cardiomyopathy, coronary artery anomalies and arrhythmogenic right ventricular cardiomyopathy. The possibility of carrying out screening to prevent these tragic cardiac deaths in young athletes has been discussed. A history of sudden cardiac death at a young age among relatives and/or the occurrence of exercise related symptoms in the active sportsperson may identify some of the individuals at risk. A pathological ECG is also a risk factor, especially in combination with a history of abnormal findings upon physical examination. For a correct evaluation of the young athlete, it is important to be aware of the normal variation of cardiac findings in athletes ("athlete's heart").

Medical and legal issues in the cardiovascular evaluation of competitive athletes.

Healthy-appearing competitive athletes may harbor unsuspected cardiovascular disease with the potential to cause sudden death. This fact raises issues of physician responsibility in preparticipation screening and eligibility/disqualification decisions. A number of medical-legal cases now represent a framework for screening and eligibility decision making in high school and college athletes. Physicians screening competitive athletes should strictly adhere to recommendations from the American Heart Association. Precedent exists for disqualifying athletes with heart disease from competition to prevent unnecessary exposure to risk of injury or death. By virtue of the court decision in Larkin v Archdiocese of Cincinnati, high school students with heart disease have no compelling right to participate in interscholastic sports without medical clearance. In Knapp v Northwestern University, an appellate court ruled that college athletes can be medically disqualified from sports and supported the use of national association medical guidelines by team physicians in formulating eligibility/disqualification decisions. This medical-legal analysis provides guidelines for physicians participating in medical evaluations of competitive athletes by clarifying the standard of care, potential pitfalls, and the evolving liability associated with this clinical practice.

Consent in medicine and sport.

Last year's football World Cup serves to highlight the confusion now surrounding the classical aim of both sport and sports medicine, namely a healthy mind in a healthy body. The recent focus on violent injuries and the exponential increase in medical litigation suggests that this relationship is not so clearly defined. One cornerstone of this traditional relationship is the concept of informed consent. We review the legal position of consent in sport, especially soccer, which still awaits clarification and draw clear parallels with surgical consent.