The “Growing” Reality of the Neurological Complications of Global “Stem Cell Tourism”

2018 ◽  
Vol 38 (02) ◽  
pp. 176-181 ◽  
Author(s):  
Katie Julian ◽  
Nick Yuhasz ◽  
Ethan Hollingsworth ◽  
Jaime Imitola
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
Clinical Research ◽  
Human Subjects ◽  
Neurological Diseases ◽  
The United States ◽  
Neurological Complications ◽  
Stem Cell Tourism ◽  
Societal Issues ◽  
Protection Of Human Subjects

Abstract“Stem cell tourism” is defined as the unethical practice of offering unproven cellular preparations to patients suffering from various medical conditions. This phenomenon is rising in the field of neurology as patients are requesting information and opportunities for treatment with stem cells for incurable conditions such as multiple sclerosis and amyotrophic lateral sclerosis, despite their clinical research and experimental designation. Here, we review the recent trends in “stem cell tourism” in both the United States and abroad, and discuss the recent reports of neurological complications from these activities. Finally, we frame critical questions for the field of neurology regarding training in the ethical, legal, and societal issues of the global “stem cell tourism,” as well as suggest strategies to alleviate this problem. Although there are ongoing legitimate clinical trials with stem cells for neurological diseases, procedures offered by “stem cell clinics” cannot be defined as clinical research. They lack the experimental and state-of-the-art framework defined by peers and the FDA that focus on human research that safeguard the protection of human subjects against economical exploitation, unwanted side effects, and futility of unproven procedures. “Stem cell tourism” ultimately exploits therapeutic hope of patients and families with incurable neurological diseases and can put in danger the legitimacy of stem cell research as a whole. We posit that an improvement in education, regulation, legislation, and involvement of authorities in global health in neurology and neurosurgery is required.

scholarly journals Post-trial access and the new version of the Declaration of Helsinki

2013 ◽  
pp. 206-207 ◽  
Author(s):  
Ricardo Palacios
Keyword(s):  
Clinical Research ◽  
Therapeutic Response ◽  
Human Subjects ◽  
The United States ◽  
Continuous Treatment ◽  
Trial Participant ◽  
Declaration Of Helsinki ◽  
Critical Issues ◽  
Protection Of Human Subjects ◽  
Post Trial

In October 2013, the World Medical Association (WMA) approved the latest version of the Declaration of Helsinki (DoH) in Fortaleza, Brazil. Post-trial access of favorable interventions was again one of the critical issues raised during the meeting. The call to clinical research actors, other than physicians, in this discussion is not new, but this is the first time, after 49 years and nine amendments, when governments are requested to take responsibilities. The primary purpose of the DoH is the protection of human subjects involved in clinical research, but since the 2000 amendment, the WMA extended their concerns to what happens to the trial participants after the study. This issue, along with the use of placebo, was one of the key points that led to the withdrawal of the DoH as reference in the United States regulation. However, only the 2013 version acknowledges that the burden of providing post-trial access for those patients on continuous treatment is far beyond the investigator’s scope. The delay between the end of a blind study and the unblinding could take several months. Meantime, the investigator is unaware if the participant received either control or experimental product. In case of therapeutic response, the investigator should provide to the participant the same treatment until the unblinding, even if it is the control product, i.e. placebo? A trial participant can get therapeutic response with an experimental product that during the unblinded analysis has failed. The risk benefit analysis on individual basis might be challenging if one considers that the clinical development can stop due to safety concerns, lack of efficacy or release of alternatives more advantageous than the investigational product. Before retaining a product still under development after a study, the physician should consider safety and efficacy information as well as therapeutic alternatives to take decisions on an individual participant, even if the patient has a favorable response with acceptable tolerance. Furthermore, product manufacturing can be discontinued, raising the need to switch the experimental product to a sustainable alternative.

Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks

Cephalalgia ◽  
2021 ◽  
pp. 033310242110299
Author(s):  
Peer Tfelt-Hansen ◽  
Karsten Jørgensen ◽  
Hans-Christoph Diener
Keyword(s):  
Clinical Research ◽  
Migraine Attack ◽  
Human Subjects ◽  
Second Step ◽  
Controlled Trials ◽  
Scientific Rigor ◽  
Protection Of Human Subjects

Purpose In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo. Conclusion To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with “scientific rigor” in the second step of these trials, and this design is not recommended.

Stem cells in brain diseases: From cell replacement to disease modeling

2011 ◽  
Vol 2 (2) ◽  
Author(s):  
Nina Kosi ◽  
Dinko Mitrečić
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
Disease Modeling ◽  
Neurological Diseases ◽  
Rapid Development ◽  
Modern Society ◽  
Brain Diseases ◽  
Stem Cell Technology ◽  
Cell Based Therapy

AbstractNeurological diseases are recognized as one of the most significant burdens of the modern society. Therefore, a new therapeutic approach applicable to nervous system represents priority of today’s medicine. A rapid development of stem cell technology in the last two decades introduced a possibility to regenerate disease-affected nervous tissue. In this vein, stem cells are envisioned as a replacement for lost neurons, a source of trophic support, a therapeutic vehicle, and as a tool for in vitro modeling. This article reviews the current concepts in stem cell-based therapy of neurological diseases and comments ongoing efforts aiming at clinical translation.

Research Ethics as Social Policy. Some Lessons from Experiences in Canada and in the United States

2003 ◽  
Vol 24 (2) ◽  
pp. 61-85
Author(s):  
Michael McDonald ◽  
Eric Meslin
Keyword(s):  
United States ◽  
Human Subjects ◽  
Ethics Committees ◽  
The United States ◽  
Prior Review ◽  
Emerging Trends ◽  
Policies And Procedures ◽  
Behavioural Research ◽  
Individual Informed Consent ◽  
Protection Of Human Subjects

For more than tlrree decades, Canada and the United States have used similar mechanisms for ensuring the protection of human subjects involved in biomedical and behavioural research: written guidelines that specify the substantive and procedural requirements of investigators and institutions; individual informed consent, and prior review and approval by interdisciplinary committees. Given the proximity of the countries to one another and the massive amount of trade and commerce that transpires between them, it is not surprising that these countries share a number of values in research. During the past fifteen years, however, both countries have experienced new challenges to their systems. Sorne of the challenges relate to new trends in research, such as genetics studies and massively increased private sector funding for pharmacological research. Other challenges relate to emerging trends in oversight policies and procedures, such as accreditation of ethics committees. Research reflects a country's particular social policies. The responses to emerging trends illustrate how such policies are evolving in sometimes quite different ways in both countries. This reflects the related but distinct political cultures and structures in the two countries. This paper will explore these trends and emerging responses, drawing lessons from each.

Biobanking Research and Privacy Laws in the United States

2016 ◽  
Vol 44 (1) ◽  
pp. 106-127 ◽  
Author(s):  
Heather L. Harrell ◽  
Mark A. Rothstein
Keyword(s):  
Human Subjects ◽  
The United States ◽  
Common Rule ◽  
State Laws ◽  
Privacy Rule ◽  
Biobank Research ◽  
Privacy Laws ◽  
The Us ◽  
Protection Of Human Subjects ◽  
Hipaa Privacy Rule

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations.

Exploring the role of stem cell therapy in treating neurodegenerative diseases: Challenges and current perspectives

2021 ◽  
Vol 16 ◽  
Author(s):  
Nidhi Puranik ◽  
Ananta Prasad Arukha ◽  
Shiv Kumar Yadav ◽  
Dhananjay Yadav ◽  
Jun O Jin
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
Glial Cells ◽  
Neurological Disorders ◽  
Neurological Diseases ◽  
Embryonic Stem ◽  
Cell Types ◽  
Cell Based Therapy ◽  
Promising Therapeutic Approach ◽  
Cord Injury

: Several human neurological disorders such as Parkinson’s disease, Alzheimer’s disease, amyotrophic lateral sclerosis; Huntington’s disease, spinal cord injury, multiple sclerosis, and brain stroke, are caused by the injury to neurons or glial cells. The recent years have witnessed the successful generation of neurons and glia cells driving efforts to develop stem-cell-based therapies for patients to combat a broad spectrum of human neurological diseases. The inadequacy of suitable cell types for cell replacement therapy in patients suffering from neurological disorders have hampered the development of this promising therapeutic approach. Attempts are thus being made to reconstruct viable neurons and glial cells from different stem cells such as the embryonic stem cells, mesenchymal stem cells, and neural stem cells. Dedicated research to cultivate stem cell-based brain transplantation therapies have been carried out. We aim at compiling the breakthroughs in the field of stem cell-based therapy for the treatment of neurodegenerative maladies, emphasizing on the shortcomings faced, victories achieved, and the future prospects of the therapy in clinical settings.

Justice, Fairness, and Membership in a Class: Conceptual Confusions and Moral Puzzles in the Regulation of Human Subjects Research

2011 ◽  
Vol 39 (3) ◽  
pp. 488-501 ◽  
Author(s):  
Ana S. Iltis
Keyword(s):  
United States ◽  
Human Subjects ◽  
United States Public Health ◽  
The United States ◽  
National Commission ◽  
Human Research ◽  
Common Rule ◽  
Department Of Health ◽  
The Common ◽  
Protection Of Human Subjects

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services (whose regulations appear at 45CFR46), to require that investigators follow the same rules for conducting human research. (The Food and Drug Administration [FDA] has its own rules (at 21CFR50 and 21CFR56), though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter the National Commission). The National Commission was appointed in 1974 as part of the National Research Act (P.L. 93-348) in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study.

scholarly journals Stem cells in neurology - current perspectives

2014 ◽  
Vol 72 (6) ◽  
pp. 457-465 ◽  
Author(s):  
Chary Ely Marquez Batista ◽  
Eric Domingos Mariano ◽  
Suely Kazue Nagahashi Marie ◽  
Manoel Jacobsen Teixeira ◽  
Matthias Morgalla ◽  
...  
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
Clinical Application ◽  
Cell Biology ◽  
Neurological Diseases ◽  
Therapeutic Option ◽  
Demyelinating Diseases ◽  
Cord Injury ◽  
Experimental Trials ◽  
Lateral Sclerosis

Central nervous system (CNS) restoration is an important clinical challenge and stem cell transplantation has been considered a promising therapeutic option for many neurological diseases. Objective : The present review aims to briefly describe stem cell biology, as well as to outline the clinical application of stem cells in the treatment of diseases of the CNS. Method : Literature review of animal and human clinical experimental trials, using the following key words: “stem cell”, “neurogenesis”, “Parkinson”, “Huntington”, “amyotrophic lateral sclerosis”, “traumatic brain injury”, “spinal cord injury”, “ischemic stroke”, and “demyelinating diseases”. Conclusion : Major recent advances in stem cell research have brought us several steps closer to their effective clinical application, which aims to develop efficient ways of regenerating the damaged CNS.

scholarly journals Ethical Regulations of Medical Research Involving Human Subjects: Exploring the Perspective of Trial Participants

2019 ◽  
Vol 9 (1) ◽  
pp. 34-49
Author(s):  
Anna Kravets
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Research ◽  
Broad Spectrum ◽  
Human Subjects ◽  
Well Being ◽  
Research Protocols ◽  
Ethnographic Data ◽  
Protection Of Human Subjects ◽  
Trial Participants

In this paper I address the question of whether the existing ethical regulations of clinical research ensure protection and well-being of human subjects. Drawing on ethnographic data gathered in Berlin, Germany, I show that German institutions which are meant to ensure the ethical validity of clinical research cannot address posed issues. It appears that these institutions (Berlin Ethik-Kommission in particular) only evaluate research protocols and do not consider the broad spectrum of processes and interactions involved in clinical research. The experience of professional human subjects, as well as the consideration of the every-day life in a clinic, shows that there is much more to clinical trials. The argument of this paper is that the inability of institutions to address protection of human subjects originates from the bureaucratic logic of their organization. Drawing on Bauman’s (1992) argument that the bureaucratic machine is characterized by separation between morality and purpose, with the example of Berlin Ethik-Kommission, I argue that the bureaucratic machine cannot be sensitive to morality and ethics, even if these are its main purposes.

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