Unproven Cell-Based Therapies – VJRegenMed

The ISCT’s ongoing battle against unproven cell & gene therapies

admin_vjr_user — Mon, 08 Nov 2021 18:22:07 +0000

Miguel Forte, MD, PhD, Bone Therapeutics SA, Gosselies, Belgium, discusses the efforts being made by the International Society for Cell & Gene Therapy (ISCT) to tackle the use of unproven cell- and gene-based therapies. He discusses the ISCT’s alignment with regulators such as the US Food and Drug Administration (FDA) and their actions against developers treating patients with unvalidated products that are marketed with unsubstantiated claims. He also highlights the importance of the growing role the cell and gene therapy industry in the translation of products to patients. This interview took place at the Advanced Therapies Congress & Expo 2021.

Tackling unproven cell-based therapies and the impact of COVID-19

admin_vjr_user — Thu, 19 Aug 2021 10:30:48 +0000

Aaron Levine, PhD, MPhil, BS, Georgia Institute of Technology, Atlanta, GA, provides an overview of the current landscape of direct-to-consumer marketing of unproven cell-based therapies in the United States. As the FDA’s enforcement discretionary period comes to an end, Dr Levine hopes to see an increased level of enforcement activity toward stem cell clinics operating outside of FDA guidelines and formal regulatory processes. He also highlights the impact of the COVID-19 pandemic, which saw an increase in the spread of health misinformation and the marketing of unproven cell-based interventions for COVID-19, resulting in enforcement action from the FDA. Finally, Dr Levine expresses his concerns surrounding the unregulated and premature growth of speculative commercial cell banking services. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

ISCT 2021 highlights: therapeutic deception, global regulation & CAR-T

admin_vjr_user — Thu, 19 Aug 2021 10:30:46 +0000

Aaron Levine, PhD, MPhil, BS, Georgia Institute of Technology, Atlanta, GA, offers his highlights from the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021. He calls attention to a regulatory session focused on therapeutic deception in direct-to-consumer marketing of unproven cell and gene therapies and the value of hearing from the United States Federal Trade Commission (FTC) on how they interact with regulatory bodies. In addition, he highlights a global regulatory workshop focused on the different ways in which health authorities deal with novel cell therapies, as well as the meeting’s coverage of chimeric antigen receptor (CAR) T-cell therapy and the development of personalized therapies for solid tumors. This interview took place during the ISCT Annual Meeting 2021.

Direct-to-consumer marketing of unproven orthopedic therapies

admin_vjr_user — Thu, 05 Aug 2021 18:50:16 +0000

Nicolas Piuzzi, MD, Cleveland Clinic, Cleveland, OH, describes the current landscape of direct-to-consumer marketing of unproven orthopedic cell-based therapies, a major challenge facing the field of orthopedics that can put patients at risk, both medically and financially. Dr Piuzzi highlights the importance for international societies to continue to work together to provide reliable, unbiased information that patients can trust, allowing them to make informed treatment decisions. He notes that researchers and clinicians also have the responsibility to continue to advance research and conduct clinical effectiveness studies so that more therapies can be covered by health insurance. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

Addressing the unproven cell-based therapy market

admin_vjr_user — Thu, 24 Jun 2021 17:15:43 +0000

Miguel Forte, MD, PhD, Bone Therapeutics SA, Gosselies, Belgium, suggests how the cell and gene therapy industry can help to address the unproven cell-based therapy market. He highlights that strong evidence-based research is required to determine whether the benefits of a particular cell-based therapy outweigh the risks before they are used in patients. Additionally, the education of patients and stakeholders is required to improve understanding of how products are developed, which products have been proven to be safe and effective and how they should be used. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

Tackling therapeutic deception in unproven therapies: highlights from ISCT 2021

admin_vjr_user — Wed, 26 May 2021 16:33:44 +0000

Laertis Ikonomou, PhD, University at Buffalo & The State University of New York, Buffalo, NY, provides an overview of a regulatory session set to take place at the ISCT Annual Meeting 2021 on unproven or unlicenced cell-based therapies and therapeutic deception. In this session, the multidisciplinary panel will discuss some of the deceptive practices used in direct-to-consumer marketing of unproven therapies and how regulatory agencies and legislators are working to address these issues at a national and international level. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

The current landscape of unproven cell-based therapies

admin_vjr_user — Wed, 26 May 2021 16:33:43 +0000

Laertis Ikonomou, PhD, University at Buffalo & The State University of New York, Buffalo, NY, provides an overview of the evolving landscape of direct-to-consumer marketing of unproven cell-based therapies, a challenge that has been facing the field of cell and gene therapies for a number of years. In line with advancements in the field in recent years, there has been an increase in the prevalence of unproven therapeutic products incorporating perinatal tissues and exosomes being offered to patients, as well as a rise in cell banking services offering the freezing of various tissues such as T-cells. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

Anticipating a crackdown on unproven cell-based therapies

admin_vjr_user — Wed, 26 May 2021 16:33:42 +0000

Following the development of the US FDA’s regenerative medicine policy framework in 2017, the agency outlined its intent to exercise enforcement discretion for certain regenerative medicine products, giving manufacturers time to submit investigational new drug (IND) and premarket approval applications. With this discretionary period coming to an end, Laertis Ikonomou, PhD, University at Buffalo & The State University of New York, Buffalo, NY, considers how the this might affect the direct-to-consumer marketing of unproven cell-based therapies in the US and the positive impact this could have on the regulation of unproven therapies worldwide. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.