Regenerative Medicine Highlights: July – September 2023
Journal Development Editor, Jasmine Hagan, shares her top papers from the July, August and September issues of Regenerative Medicine.
This quarter, we published over 20 papers encompassing a wide range of topics including tissue engineering, regulation and policy and clinical translation.
In this feature, I share some of my top articles from issues 7, 8 and 9 of Volume 18, providing a snapshot of some of the most exciting work in the field published in Regenerative Medicine.
How proven is a ‘proven intervention’? Ethics of placebo controls in light of conditional approval programs
This perspective from our July issue explores the challenges of determining whether “proven treatment” exists under conditional approval pathways for regenerative experimental therapies and the ethics of using a placebo comparator. Within regulatory frameworks, conditional approval programs are a pathway to accelerate patients’ access to therapies. In cases where there may be a lack of therapeutic interventions available for serious or life-threatening diseases, conditional approval may be granted on the basis that further data on the efficacy and data is obtained following approval. This poses a challenge for determining the effectiveness of a therapy that has been granted through conditional approval programs, without being supported by evidence from randomized controlled clinical trials.
In the article, the author emphasizes that approval is not an indicator of efficacy. They highlight the need for rigorous evidence to support the therapeutic benefits of a therapy, as well as encourage patients and medical professionals to keep informed about the efficacy status of therapeutic products that have been granted through a conditional approval program.
Comparative analysis of rule elements for transportation of cell therapy products among regulations and standards
Ensuring the quality of a cell therapy product during transportation is an important logistical aspect in the development and manufacturing of cell therapies. With the primary goal of identifying differences between Good Distribution Practice and four standards related to the transportation of cell therapy products, the authors conducted a comparative analysis.
The study identifies and compiles key elements from the regulation and standards, proposing a new framework for the transportation of cell therapy products.
The regulatory challenge of 3D bioprinting
As the field of regenerative medicine continues to expand to new horizons, regulation remains at the forefront of a rapidly evolving landscape. By combining the engineering challenges of 3D printing with the biological challenges of advanced therapies, regulators are posed with a challenge that must be addressed. In the study, O’Connell et al. seek to provide an overview of regulatory challenges in bioprinting within the context of regenerative medicine. For example, the authors argue that the current regulatory framework designed for mass-manufactured therapies does not consider bespoke situations e.g., 3D-printed regenerative implants, where living cells have been included in the fabrication process.
The authors highlight that before these products can be clinically translated, it is important that these challenges around 3D bioprinting regulation are addressed. Analyzing several elements including classification, quality control, technical issues and standardization, the authors propose that instead of a product-based regulatory framework, a process-based regulatory framework could be the solution to ensuring the safety and efficacy of these products.
Current evidence on mesenchymal stem cells for hip osteoarthritis: a narrative review
Osteoarthritis is a degenerative joint disease that affects millions of individuals worldwide. In search of an effective therapeutic approach to reduce pain and promote healing, researchers have turned to mesenchymal stem cells. This review by Oliveira et al. is the first to evaluate and compare current literature on the use of mesenchymal stem cells for hip osteoarthritis.
With the aim of helping clinicians and researchers working in this area make informed decisions, the authors draw conclusions from clinical studies evaluating MSCs for hip osteoarthritis. The findings suggest that this approach is safe, with promising clinical outcomes at 6 months after treatment. Nevertheless, the authors emphasize the necessity for large-scale randomized controlled trials to fully assess the clinical efficacy of the therapy.
Don’t forget to check out the rest of the articles from the July, August and September issues of Volume 18.
If you have any queries about Regenerative Medicine or are interested in publishing in the journal, please contact Journal Development Editor, Jasmine Hagan ([email protected]).