Global innovations and challenges in regenerative medicine

Contributors

This page contains resources developed by the Law, Public Policy and Social License for Next-Generation Regenerative Medicine Working Group.

Highlighting global innovations and challenges of regenerative medicine to create a harmonized regulatory framework

There is a need to develop clear and robust regulations to guide the translation of regenerative medicine (RM) research into interventions that improve public health. While regulatory frameworks exist for clinical trials and marketing of RM products, attention is needed to address the specific challenges posed by these emerging technologies. Our work examines RM policy and governance across regions of the Global South to understand the regulatory approaches, innovations and challenges that RM brings. By focusing on under-examined areas in literature, this study aims to contribute to global discussions on RM government and support the development of inclusive and well-suited regulatory frameworks.

Report on Regulatory Frameworks for Clinical Research on and Marketing Authorization of Regenerative Medicine Products in Low- and Middle-Income Countries

Summary: Advances global regulatory and policy discourse on regenerative medicine by providing a first-of-its-kind analysis of governance frameworks in low- and middle-income countries, highlighting diverse approaches and key challenges to support more coordinated and equitable global oversight.

Impact: Enhances understanding of regenerative medicine governance by illuminating policy landscapes in underexamined regions, thereby promoting more globally coherent and inclusive regulatory strategies

Authors: Ogbogu, U. & Case, N.

Read the report here

Report on Regenerative Medicine Clinical Research Activities and Product Pipelines in Low- and Middle-Income Countries in Africa and Asia

Summary: The report provides the first comprehensive mapping of mid-to late-stage regenerative medicine clinical trials and product pipelines in low- and middle- income countries in Africa and Asia. The report offers critical insights that support the inclusion of under examined regions in global regulatory and commercialization frameworks for regenerative medicine.

Impact: Strengthens global understanding of regenerative medicine by highlighting the clinical research and innovation landscape in under-examined low- and middle-income countries, thereby informing more inclusive and interoperable regulatory and policy frameworks.

Authors: Ogbogu, U. & Case, N.

Read the report here

Clinical use of autologous cell-based therapies in an evolving regulatory landscape: A survey of patient experiences and perceptions

Summary: The study makes a novel contribution to the literature by providing the first analysis of patients’ experiences and perceptions of an emerging cell-based therapy within an evolving regulatory landscape.

Impact: Provides critical insights to inform policy development, promote scientific rigor, and ensure ethical oversight of autologous cell-based therapies and other emerging cell-based therapies.

Authors: Ogbogu, U. & Case, N.

Read the study here

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Global innovations and challenges in regenerative medicine

Contributors

Highlighting global innovations and challenges of regenerative medicine to create a harmonized regulatory framework

Report on Regulatory Frameworks for Clinical Research on and Marketing Authorization of Regenerative Medicine Products in Low- and Middle-Income Countries

Report on Regenerative Medicine Clinical Research Activities and Product Pipelines in Low- and Middle-Income Countries in Africa and Asia

Clinical use of autologous cell-based therapies in an evolving regulatory landscape: A survey of patient experiences and perceptions