TY - JOUR
T1 - Powering prescription
T2 - Mitochondria as "Living Drugs" - Definition, clinical applications, and industry advancements
AU - Caicedo, Andrés
AU - Morales, Emilia
AU - Moyano, Aldana
AU - Peñaherrera, Sebastian
AU - Peña-Cisneros, José
AU - Benavides-Almeida, Abigail
AU - Pérez-Meza, Álvaro A
AU - Haro-Vinueza, Alissen
AU - Ruiz, Cristina
AU - Robayo, Paola
AU - Tenesaca, Doménica
AU - Barba, Diego
AU - Zambrano, Kevin
AU - Castañeda, Verónica
AU - Singh, Keshav K
PY - 2024/1
Y1 - 2024/1
N2 - 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.
AB - 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.
KW - Acellular therapy
KW - Advanced therapeutic medicinal products (ATMPs)
KW - Artificial mitochondrial transfer transplant (AMT/T)
KW - Cell therapy
KW - Industry
KW - Innovation
KW - Living drugs (LDs)
KW - Mitochondria
U2 - 10.1016/j.phrs.2023.107018
DO - 10.1016/j.phrs.2023.107018
M3 - (Systematic) Review article
SN - 1043-6618
VL - 199
JO - Pharmacological Research
JF - Pharmacological Research
M1 - 107018
ER -