Peek behind the paper: Preparing regenerative therapies for clinical application: proposals for responsible translation

In this post, learn more about a new paper from Shane A Shapiro, Cambray G Smith, Jennifer R Arthurs and Zubin Master (Mayo Clinic; MN, USA).

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Regenerative medicine therapies have progressed rapidly in the last few years and are fast becoming available in a clinical setting. However, key questions remain: what is responsible translation? What more needs to be done to ensure this is happening?

In a recent paper, published in Regenerative Medicine, Shane A Shapiro, Cambray G Smith, Jennifer R Arthurs and Zubin Master (Mayo Clinic; MN, USA) share their insight into this problem. At Phacilitate Leaders World (January 22-25, Miami, FL, USA), co-located with the World Stem Cell Summit, we spoke to authors Shane Shapiro and Zubin Master to find out more.

A peek behind the paper: Shane Shapiro

An ethical perspective: Zubin Master

Please introduce yourself and your institution

I am an Associate Professor in the Biomedical Ethics Research Program and the Center for Regenerative Medicine at Mayo Clinic. I work on the ethics and policy of regenerative medicine.

You recently published a commentary on ‘Preparing regenerative therapies for clinical application: proposals for responsible translation’ in Regenerative Medicine. How did you come to be involved in producing this paper?

Shane Shapiro and I have been working together on several projects of mutual interest since I arrived at Mayo Clinic in 2017. Within Mayo Clinic’s Center of Regenerative Medicine, we share a common vision of responsible translation of regenerative medicine products and services. This includes not only advancing the science of regenerative medicine, but to simultaneously ensure regenerative medicine advances in an ethical manner. This would include informing patients about the state of the science, what interventions are being investigated in clinical trials and what has been approved by the FDA.

Beyond informing patients, Dr Shapiro and I have a common interest in tracking patient experiences and clinical outcomes. By patient experiences, we are interested in their attitudes including expectations of regenerative therapies, the informed consent process and their satisfaction of the clinical encounter.

Are there any bioethical questions or challenges unique to regenerative medicine?

Certainly there are unique challenges to regenerative medicine from a bioethical standpoint. I think most salient is the issue of ensuring that patients are well informed as the field of regenerative medicine advances, and products and services begin to be developed, tested and approved. Ensuring patients are adequately informed about the state of regenerative science is especially important because there is much misinformation about regenerative therapies being given to people.

We are seeing a rise of unproven regenerative therapies being offered as effective treatments. Responsible translation means that we need to ensure patients are making well-informed decisions and the challenge is how we effectively provide accurate information while countering hype, a patient’s desire to receive some form of care, and the misinformation out there. We feel that Mayo’s Regenerative Medicine Consultation Service is an ideal forum where patients can ask about regenerative therapies to a consultant and the consultant can answer questions, correct misperceptions, point to good information resources, and refer patients to clinical trials or services appropriate to their needs.

Do you think regenerative medicine developers are currently adequately taking the patient and physician viewpoint into account during translation of therapies? How could this improve?

Regenerative medicine is a broad field involving multiple medical specialties and many diverse stakeholders. As we know, much of what is considered developing regenerative therapies involves drug and/or device development and not just procedures. We are hopeful that our research will inform universities, hospitals and industry partners as to the patient experience as regenerative sciences develop.

The commentary describes three components in the Mayo Clinic Regenerative Medicine Therapeutics Program: the Regenerative Medicine Consult Service (RMCS), the Therapeutic Suites and the Regenerative Evidence-Based Outcomes Registry (REBO). How do you manage patient perception regarding the RMCS vs other ‘educational seminars’ offered by clinics touting unproven treatments?

Much of what we do in the RMCS is to provide clear and accurate information and navigate patients appropriately. The “educational seminars” offered by clinics you speak of attempt to sell something at the end of the seminar. The RMCS service provides patient information and navigates patients to appropriate physician groups which may have a regenerative option for them. In several cases, there may not be a suitable option for patients in which case this would be something the consultant would relay back to the patient.

If a regenerative option is indicated, it is up to the physician group to make that determination, not the RMCS. Physicians clearly inform patients of the procedure, the risks involved, and other information so they can make a choice that is best for them. The RMCS manages patient expectations by providing evidence-based information and navigating them appropriately.

What are the potential ethical questions regarding a registry of patient data, such as REBO, particularly in a field such as regenerative medicine where the patient populations for particular indications are relatively small?

One of the concerns associated with patient registries is to ensure adequate privacy protections and reduce the possibility of reidentification of patients. These concerns can, however, be addressed with existing solutions in data protection and appropriate oversight.

Where do you see regenerative medicine in 15 years?

I hope more regenerative medicine interventions will continue to be developed, taken into clinical trials, and that more interventions will be approved by the FDA so that we can meet the needs of some patients.

To tie a bit into an above question, another ethical issue we need to be mindful of now is the fair distribution of regenerative products and treatments. In some cases, regenerative options could be individualized to patients meaning we would need to identify the best approach based on the clinical indications of the patient, and then to develop a product to administer. In thinking about responsible innovation, we need to begin to explore pathways that allow us to reduce individual costs as the regenerative product is being developed.

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