Abstract: The current invention relates to a process for the manufacturing of a composition of extracellular vesicles (EVs) derived from mesenchymal stromal cells (MSCs), said method comprises: culturing and expanding MSCs in a serum-free and xeno-free medium comprising purified human serum albumin and human transferrin; —collecting cell supernatant, said cell supernatant comprises EVs; —filtering said cell supernatant to obtain EVs; and concentrating said EVs, preferably by means of ultrafiltration. In a second and further aspect, said invention is directed to compositions comprising EVs and their clinical use.

Abstract: The current invention relates to a composition comprising extracellular vesicles (EVs) derived from mesenchymal stromal cells (MSCs), said EVs are part of a population of particles in said composition having a particle size of between 0.05 and 0.22 micron, said concentration of these particles is at least 1×1011 particles per ml of composition and wherein at least 90% of said particles with particle size of between 0.05 and 0.22 micron are EVs, said EVs are defined by having a concentration of intra-vesicular Annexin V of at least 40 ng/ml and a concentration of extra-vesicular Annexin V of less than 1 ng/ml. The current invention also relates to the use such composition.

Abstract: The current invention relates to a process for the manufacturing of extracellular vesicles (EVs) associated with proteins, derived from mesenchymal stromal cells (MSCs), said process comprises the steps of: - Purifying EVs from a cell medium comprising MSCs, wherein said purifying occurs via at least one filtration step of said medium; followed by - a concentration step of the filtrate of said at least one filtration step, wherein said EVs are concentrated by means of tangential flow filtration in a TFF device; and - wherein during said TFF step the EVs are associated with one or more exogenous proteins inside of said TFF device, or in a vessel fluidly connected to said TFF device to which said EVs are transferred from said TFF. The current invention also relates to a pharmaceutical composition comprising a therapeutically effective amount of EVs associated with proteins, and the use thereof.