Regenerative medicine aims at the functional restoration of a damaged, malfunctioning, or missing tissue. Three main approaches in Regenerative Medicine include 1) cell-based therapies, 2) “classical tissue engineering” using cells and a bio-degradable scaffold to form a tissue, and 3) material-based approaches which rely on bio-degradable materials, often functionalized with cellular functions. Although stem cell and progenitor populations are known to play a central role in these approaches, it has become increasingly apparent that products secreted by these cells play an additive supportive, paracrine role in stem-cell based therapies. These products include extracellular vesicles (EVs).
Extracellular vesicles are nano-sized vesicles secreted by a wide variety of cells and act as
mediators of intercellular communication, transferring proteins and genetic material between cells. EVs released from specific cell types, in particular mesenchymal stem / stromal cells (MSCs), have protective properties and positive effects on regeneration in many tissues, offering powerful therapeutic potential. Pre-clinical and clinical data indicate that MSC-derived EVs have significant potential as active agents in the treatment of several human diseases through modulation of the immune system and via stimulation of regeneration. Immune-modulatory effects have been demonstrated in conditions such as graft-versus-host-disease and osteoarthritis, whereas regenerative properties have been shown in kidney and cardiovascular diseases. Despite the promising pre-clinical findings on EV therapeutic potency, the translation of these results into clinical application of EVs remains difficult. Several hurdles need to be overcome in order to fully exploit the therapeutic potential of EV-based drugs in the future. Currently, there is great heterogeneity in study design, cell culture and EV isolation, quality control and characterization which requires further attention.
The aim of this Research Topic is to provide a representative overview of current possibilities and hurdles in the clinical application of extracellular vesicles for regenerative medicine. We welcome the submission of Reviews, Mini-Reviews and Original Research articles plus Methods, Protocols, Technology Report, Hypothesis and Theory, Perspective, Clinical Trial, Case Report, Classification, General Commentary, Opinion and Systematic Review articles that cover, but are not limited to, the following topics:
1. Current applications of extracellular vesicles in regenerative medicine including clinical trials.
2. Characterization of the immune-modulatory effects of extracellular vesicles in the context of regenerative medicine.
3. Therapeutic use of extracellular vesicles in inflammatory diseases including graft-versus-host disease and cardiovascular disease.
4. Therapeutic use of EVs in diseases of tissues, including, but not limited to the heart, kidney, and liver and for inborn errors of metabolism.
5. Limitations of off-the-shelf extracellular vesicle-based products for therapeutic use.
6. Practical concerns, scientific background, and regulatory aspects, including standardization, GMP-compliance, mode-of-action, quality control, and local and international legislation involving cell- and EV-based therapeutics.
Regenerative medicine aims at the functional restoration of a damaged, malfunctioning, or missing tissue. Three main approaches in Regenerative Medicine include 1) cell-based therapies, 2) “classical tissue engineering” using cells and a bio-degradable scaffold to form a tissue, and 3) material-based approaches which rely on bio-degradable materials, often functionalized with cellular functions. Although stem cell and progenitor populations are known to play a central role in these approaches, it has become increasingly apparent that products secreted by these cells play an additive supportive, paracrine role in stem-cell based therapies. These products include extracellular vesicles (EVs).
Extracellular vesicles are nano-sized vesicles secreted by a wide variety of cells and act as
mediators of intercellular communication, transferring proteins and genetic material between cells. EVs released from specific cell types, in particular mesenchymal stem / stromal cells (MSCs), have protective properties and positive effects on regeneration in many tissues, offering powerful therapeutic potential. Pre-clinical and clinical data indicate that MSC-derived EVs have significant potential as active agents in the treatment of several human diseases through modulation of the immune system and via stimulation of regeneration. Immune-modulatory effects have been demonstrated in conditions such as graft-versus-host-disease and osteoarthritis, whereas regenerative properties have been shown in kidney and cardiovascular diseases. Despite the promising pre-clinical findings on EV therapeutic potency, the translation of these results into clinical application of EVs remains difficult. Several hurdles need to be overcome in order to fully exploit the therapeutic potential of EV-based drugs in the future. Currently, there is great heterogeneity in study design, cell culture and EV isolation, quality control and characterization which requires further attention.
The aim of this Research Topic is to provide a representative overview of current possibilities and hurdles in the clinical application of extracellular vesicles for regenerative medicine. We welcome the submission of Reviews, Mini-Reviews and Original Research articles plus Methods, Protocols, Technology Report, Hypothesis and Theory, Perspective, Clinical Trial, Case Report, Classification, General Commentary, Opinion and Systematic Review articles that cover, but are not limited to, the following topics:
1. Current applications of extracellular vesicles in regenerative medicine including clinical trials.
2. Characterization of the immune-modulatory effects of extracellular vesicles in the context of regenerative medicine.
3. Therapeutic use of extracellular vesicles in inflammatory diseases including graft-versus-host disease and cardiovascular disease.
4. Therapeutic use of EVs in diseases of tissues, including, but not limited to the heart, kidney, and liver and for inborn errors of metabolism.
5. Limitations of off-the-shelf extracellular vesicle-based products for therapeutic use.
6. Practical concerns, scientific background, and regulatory aspects, including standardization, GMP-compliance, mode-of-action, quality control, and local and international legislation involving cell- and EV-based therapeutics.
