Unproven stem cell interventions: A global public health problem requiring global deliberation

Master, Zubin; Matthews, Kirstin R.W.; Abou‐El‐Enein, Mohamed

doi:10.1016/j.stemcr.2021.05.004

Cited by 25 publications

(14 citation statements)

References 47 publications

(63 reference statements)

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“…An important factor for successful implementation of therapies using UA-ADRCs will be the proactive support of regulatory authorities to design frameworks that, while addressing valid concerns around the safety of unproven therapies that can be found in some places currently [ 153 ], show a clear path to market approval and reimbursement. Some progress in that direction can be observed in a number of jurisdictions.…”

Section: Discussionmentioning

confidence: 99%

Perspective: Why and How Ubiquitously Distributed, Vascular-Associated, Pluripotent Stem Cells in the Adult Body (vaPS Cells) Are the Next Generation of Medicine

Alt

Schmitz

Bai

2021

Cells

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A certain cell type can be isolated from different organs in the adult body that can differentiate into ectoderm, mesoderm, and endoderm, providing significant support for the existence of a certain type of small, vascular-associated, pluripotent stem cell ubiquitously distributed in all organs in the adult body (vaPS cells). These vaPS cells fundamentally differ from embryonic stem cells and induced pluripotent stem cells in that the latter possess the necessary genetic guidance that makes them intrinsically pluripotent. In contrast, vaPS cells do not have this intrinsic genetic guidance, but are able to differentiate into somatic cells of all three lineages under guidance of the microenvironment they are located in, independent from the original tissue or organ where they had resided. These vaPS cells are of high relevance for clinical application because they are contained in unmodified, autologous, adipose-derived regenerative cells (UA-ADRCs). The latter can be obtained from and re-applied to the same patient at the point of care, without the need for further processing, manipulation, and culturing. These findings as well as various clinical examples presented in this paper demonstrate the potential of UA-ADRCs for enabling an entirely new generation of medicine for the benefit of patients and healthcare systems.

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Section: Discussionmentioning

confidence: 99%

Perspective: Why and How Ubiquitously Distributed, Vascular-Associated, Pluripotent Stem Cells in the Adult Body (vaPS Cells) Are the Next Generation of Medicine

Alt

Schmitz

Bai

2021

Cells

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“…A recent proposal for an “Expert Advisory Committee on Regenerative Medicine” through the World Health Organization would begin to promote regulatory approaches and provide educational material and guidance in this area. 3 Lastly, clinicians may contact relevant professional societies or associations that work to promote responsible use of orthobiologics, such as the International Society for Cell and Gene Therapy and the International Society for Stem Cell Research.…”

Section: Reporting Mechanisms For Unproven Products and Questionable ...mentioning

confidence: 99%

Marketing of Unproven and Unapproved Regenerative Medicine Therapies

Rodeo

2024

Sports Health: A Multidisciplinary Approach

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You may have received the same blast email that I have received a number of times from a company in Scottsdale, Arizona, that opens with "End of Year Blowout Sale: 3 for 1 on Exosomes or Whartons Jelly." The email further states that these products are "manufactured in an FDAregistered, cGMP compliant, ISO Certified lab," despite the fact that such birth products can be used only in a registered FDA clinical trial, since a directive from the United States (US) Food and Drug Administration (FDA) on May 31, 2021. This is a good example of the aggressive, direct-to-consumer marketing of unapproved and unproven cell therapies.As I am writing this editorial, I see this headline from MedPage Today, January 22, 2024: "FDA Warns Exosome Maker for Marketing Outside Its IND". According to this article, the manufacturer received an Investigational New Drug (IND) for a phase I/IIa clinical trial evaluating a single intravenous dose of a drug to treat COVID-19. However, the company apparently advertised their product for numerous other conditions outside of this specific IND. Furthermore, the FDA cited the company for "significant deviations" from current good manufacturing practice requirements as well as issues with sterility testing of their product.The 2 instances documented above point out some of the challenges in the rapidly growing regenerative medicine arena. The allure of regenerative medicine has led to a global industry of direct-to-consumer offerings of biologic products that, despite their promising potential, often have very little clinical data to support their use. This has been a pervasive problem in the area of regenerative medicine and is only growing. Regenerative medicine and orthobiologics can be lucrative, leading to aggressive marketing of products that have not been tested adequately for safety and/or efficacy. In this editorial I will explain some of the tactics used in these persuasive and aggressive marketing schemes. I will then briefly describe the criteria that should be considered before a product might be considered "proven", and finally I will list some mechanisms that can be used to report deceptive advertising claims and inappropriate marketing of unproven therapies.

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“… Master et al. (2021) declared that the unproven stem cell intervention (SCI) industry is a global health problem and called for the establishment of a World Health Organization (WHO) expert advisory committee on regenerative medicine to tackle this issue beyond the efforts of individual countries.…”

Section: Main Textmentioning

confidence: 99%

Financial risks posed by unproven cell interventions: Estimation of refunds from medical expense deductions in Japan

Hatta¹,

Ide

Fujita

et al. 2022

Stem Cell Reports

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Unproven stem cell interventions: A global public health problem requiring global deliberation

Cited by 25 publications

References 47 publications

Perspective: Why and How Ubiquitously Distributed, Vascular-Associated, Pluripotent Stem Cells in the Adult Body (vaPS Cells) Are the Next Generation of Medicine

Perspective: Why and How Ubiquitously Distributed, Vascular-Associated, Pluripotent Stem Cells in the Adult Body (vaPS Cells) Are the Next Generation of Medicine

Marketing of Unproven and Unapproved Regenerative Medicine Therapies

Financial risks posed by unproven cell interventions: Estimation of refunds from medical expense deductions in Japan

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