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Posted on June 18, 2021 at 1:28 PM

by A. Rahman Ford, JD, PhD

There can be no question that current FDA regulations regarding the use of one’s own stem cells (autologous therapies) to treat or potentially cure disabling conditions are very restrictive. Under most circumstances stem cells extracted from one person, processed, and then administered to the same person are legally considered “drugs” and must be subjected to the rather long and expensive clinical trial process. Nevertheless, and despite the persistent threat of FDA warning letters and lawsuits, an increasing number of clinics offer autologous stem cell therapy (SCT). This proliferation can be seen as a market-driven response to a growing number of people with disabling medical conditions, many of whom have exhausted mainstream medical modalities like pills and surgeries.

For some time, the conventional bioethical position has been that business concerns offering autologous SCT were “rogue” clinics offering “harmful” and “unproven” therapies in a “wild west” of FDA laissez faire oversight. This position further expounds that more stringent policing tactics by federal and state governments are needed to protect the health, safety and welfare of vulnerable Americans whose illnesses make them desperate and susceptible to victimization by “predatory,” “profit-driven” SCT clinics. Setting aside the questionable veracity of such claims, the continued growth in the number of clinics offering autologous therapies demonstrates that the conventional bioethical position, as articulated and repeated almost reflexively in both mainstream and academic publications, has become a rather meaningless ethical meme, rhetoric for rhetoric’s sake. What’s more, it may actually be hurting those it purports to protect the most, the disabled.

A new, revised bioethical posture for autologous SCT needed. This new posture should thoughtfully incorporate the right of persons with disabilities to improve their physical condition with their own cells and to make thoughtful, informed decisions about how those cells are used. Thus, a revised posture would accurately acknowledge the deleterious impact that certain FDA regulatory restrictions have on a disabled person using their own cells to improve or potentially cure their condition. Calls made by SCT bioethicists for enhanced policing tactics by federal and state institutions actually exacerbate the precarious health predicament of those most vulnerable, further victimizing persons with disabilities. Consequently, in the case of autologous SCT, the regulatory restrictions on autologous therapies can cause more suffering and represent a greater trespass to the rights of disabled persons than the alleged “bad acts” of the SCT clinics themselves.

It’s time for conventional SCT ethicists to concede that rather than safeguarding the rights of disabled persons, the mainstream bioethical position on autologous SCT almost seems contrary to a progressive, more expansive concept of disability rights. Knee-jerk condemnation of clinics offering autologous therapies may be popular and provocative, but it obscures the medical disenfranchisement of the disabled. A new ethical approach must give more weight to patient preference and the right of persons with disabilities to improve their quality of life in a restorative, potentially curative way. Thus, this new autologous SCT ethical posture would move away from reactive regulatory restrictions and toward increased patient autonomy and a reinvigorated disability justice.

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