Wharton's jelly

Pathology

Nanotechnology

Mesenchymal stem cell

Microvesicles

Characterization (materials science)

Biology

Gene

Cord lining

Endothelial stem cell

Biomedical engineering

microRNA

Stromal cell

Adult stem cell

Chemistry

Materials science

In vitro

Immunology

Umbilical cord

Extracellular

Cell biology

Extracellular vesicles

Biochemistry

Medicine

Cytotherapy

Extracellular vesicles (EVs) derived from mesenchymal stromal cells (MSCs) may deliver therapeutic effects that are comparable to their parental cells. MSC-EVs are promising agents for the treatment of a variety of diseases. To reach the intermediate goal of clinically testing safety and efficacy of EVs, strategies should strive for efficient translation of current EV research. On the basis of our in vitro an in vivo findings regarding the biological actions of EVs and our experience in manufacturing biological stem cell therapeutics for routine use and clinical testing, we discuss strategies of manufacturing and quality control of umbilical cord–derived MSC-EVs. We introduce guidelines of good manufacturing practice and their practicability along the path from the laboratory to the patient. We present aspects of manufacturing and final product quality testing and highlight the principle of "The process is the product." The approach presented in this perspective article may facilitate translational research during the development of complex biological EV-based therapeutics in a very early stage of manufacturing as well as during early clinical safety and proof-of-concept testing.

Manufacturing and characterization of extracellular vesicles from umbilical cord–derived mesenchymal stromal cells for clinical testing