Powering prescription: Mitochondria as "Living Drugs" - Definition, clinical applications, and industry advancements.

Authors

• Andrés Caicedo
• Emilia Morales
• Aldana Moyano
• Sebastian Peñaherrera
• José Peña-Cisneros
• Abigail Benavides-Almeida
• Álvaro A Pérez-Meza
• Alissen Haro-Vinueza
• Cristina Ruiz
• Paola Robayo
• Doménica Tenesaca
• Diego Barba
• Kevin Zambrano
• Verónica Castañeda
• Keshav K Singh

Publication/Presentation Date

1-1-2024

Abstract

Mitochondria's role as engines and beacons of metabolism and determinants of cellular health is being redefined through their therapeutic application as "Living Drugs" (LDs). Artificial mitochondrial transfer/transplant (AMT/T), encompassing various techniques to modify, enrich, or restore mitochondria in cells and tissues, is revolutionizing acellular therapies and the future of medicine. This article proposes a necessary definition for LDs within the Advanced Therapeutic Medicinal Products (ATMPs) framework. While recognizing different types of LDs as ATMPs, such as mesenchymal stem cells (MSCs) and chimeric antigen receptor T (CAR T) cells, we focus on mitochondria due to their unique attributes that distinguish them from traditional cell therapies. These attributes include their inherent living nature, diverse sources, industry applicability, validation, customizability for therapeutic needs, and their capability to adapt and respond within recipient cells. We trace the journey from initial breakthroughs in AMT/T to the current state-of-the-art applications by emerging innovative companies, highlighting the need for manufacturing standards to navigate the transition of mitochondrial therapies from concept to clinical practice. By providing a comprehensive overview of the scientific, clinical, and commercial landscape of mitochondria as LDs, this article contributes to the essential dialogue among regulatory agencies, academia, and industry to shape their future in medicine.

Volume

199

First Page

107018

Last Page

107018

ISSN

1096-1186

Published In/Presented At

Caicedo, A., Morales, E., Moyano, A., Peñaherrera, S., Peña-Cisneros, J., Benavides-Almeida, A., Pérez-Meza, Á. A., Haro-Vinueza, A., Ruiz, C., Robayo, P., Tenesaca, D., Barba, D., Zambrano, K., Castañeda, V., & Singh, K. K. (2024). Powering prescription: Mitochondria as "Living Drugs" - Definition, clinical applications, and industry advancements. Pharmacological research, 199, 107018. https://doi.org/10.1016/j.phrs.2023.107018

Disciplines

Medicine and Health Sciences

PubMedID

38013162

Department(s)

Fellows and Residents

Document Type

Article