MSC Secretome
The complete cellular output of soluble proteins, lipids, metabolites, extracellular vesicles and other released biological material.
The MSC secretome is the complete collection of soluble and vesicular biological material released by mesenchymal stromal cells into their surrounding environment. It includes cytokines, chemokines, growth factors, proteins, metabolites, lipids and extracellular vesicles.
Mesenchymal stromal cells continuously release biological signals into the environment surrounding them. The collective output of this cellular secretion is known as the MSC secretome.
The secretome contains both freely soluble molecules and membrane-enclosed extracellular vesicles. It is therefore broader than purified exosomes, small extracellular vesicles or an isolated protein preparation.
In practical laboratory work, the secretome is commonly recovered through conditioned medium. That collected medium may then be clarified, concentrated, fractionated, purified or formulated according to the intended research or product objective.
The complete cellular output of soluble proteins, lipids, metabolites, extracellular vesicles and other released biological material.
The culture medium collected after MSCs have released secretome components into the surrounding liquid environment.
A processed preparation produced by concentrating, fractionating, purifying or formulating selected components of the MSC secretome.
MSC-secretome activity is principally associated with paracrine signalling rather than direct replacement of damaged tissue by the source cells.
MSC-derived factors may influence nearby or distant recipient cells without requiring the source cells to become permanently incorporated into the tissue.
Cytokines, chemokines, proteins and vesicles may influence macrophages, lymphocytes, dendritic cells and other immune-cell populations.
Secreted factors are studied for their potential to support cellular survival, stress resistance, migration and endogenous repair responses.
Selected secretome components may influence endothelial-cell activity, angiogenic pathways and microvascular support in experimental systems.
Proteins and enzymes may affect extracellular-matrix synthesis, degradation, fibrosis-related signalling and tissue remodelling.
Secretome-associated vesicles may interact with recipient-cell membranes and carry proteins, lipids, RNA and other molecular material.
The secretome is not differentiated. The MSC source cells may be expanded, primed or lineage-directed; their released biological output is then collected and processed.
Define the MSC tissue source, donor, immunophenotype, passage number, viability and culture history.
Expand cells under documented culture-medium, supplement, confluence, oxygen and environmental conditions.
Where scientifically justified, expose MSCs to defined hypoxic, inflammatory, mechanical or three-dimensional culture conditions intended to modify their secretory profile.
Maintain MSCs in a defined collection medium for a controlled period during which soluble and vesicular factors accumulate.
Collect the conditioned medium using a documented procedure designed to maintain traceability and microbiological control.
Remove intact cells, cellular debris and selected larger particles through controlled centrifugation, filtration or related methods.
Concentrate the complete secretome or separate it into soluble, extracellular-vesicle-enriched or extracellular-vesicle-depleted fractions.
Prepare the intended concentration, carrier, excipients, container and final presentation.
Review composition, particle profile, contaminants, microbiological quality, stability and mechanism-relevant biological activity.
Composition must be established analytically and cannot be inferred solely from the term MSC.
Soluble proteins involved in immune regulation, inflammation and communication between cells.
Signalling molecules capable of influencing cellular migration, recruitment and tissue localisation.
Factors associated with cellular survival, proliferation, vascular signalling and matrix biology.
Heterogeneous membrane-enclosed particles carrying proteins, lipids, nucleic acids and metabolites.
Enzymes and regulatory proteins associated with extracellular-matrix production and remodelling.
Vesicular and non-vesicular lipid components capable of participating in cellular signalling.
Products of cellular metabolism that may influence the biological profile of the preparation.
Vesicle-associated RNA and other nucleic-acid material may form part of the secretome.
Media proteins, supplements and process-related materials may remain unless specifically removed.
These categories describe research and development areas. They do not establish approved indications or proven therapeutic effectiveness.
Research examines fibroblast activity, epithelial repair, angiogenic signalling, inflammation and extracellular-matrix production.
Laboratory and preclinical research includes cartilage, tendon, bone, muscle and inflammatory joint environments.
Studies evaluate neuroinflammatory, trophic, vascular and cytoprotective signalling rather than direct replacement of neurons.
Research examines secretome interaction with macrophages, lymphocytes, dendritic cells and inflammatory signalling pathways.
Preclinical and early translational programmes investigate inflammatory, vascular and tissue-support pathways in lung injury.
Research includes angiogenesis, myocardial injury, vascular support and cellular-survival mechanisms.
Experimental programmes examine inflammation, fibrosis, apoptosis and tissue-support signalling.
Secretome and conditioned-medium preparations are being studied for selected ocular-surface and tissue-repair applications.
The MSC secretome may serve as starting material for purified proteins, EV fractions or defined combinations of bioactive components.
Most MSC-secretome applications remain within laboratory research, preclinical development and early human investigation.
Limited clinical studies have evaluated secretome or conditioned-medium preparations in areas such as wound healing, dermatology, inflammatory disease and pulmonary injury. These studies do not establish that all MSC-secretome products are clinically effective or interchangeable.
Commercial availability at a clinic or through an online supplier does not independently demonstrate product identity, manufacturing consistency, regulatory authorisation or clinical efficacy.
The MSC secretome is not inherently patient-specific and is not automatically suitable for mass marketing. Its development model depends on the source cells, manufacturing system, intended use and regulatory pathway.
A secretome preparation may be linked to an individual patient when produced from autologous cells or under a defined named-patient protocol.
Secretome products may also be developed from qualified allogeneic MSC banks using a controlled, repeatable manufacturing process.
A scalable manufacturing process may support broader distribution, but it does not by itself create an authorised medical product.
Commercial distribution requires appropriate product classification, manufacturing controls, safety evaluation, clinical evidence, labelling, traceability and jurisdiction-specific regulatory authorisation.
Total protein concentration alone is insufficient to establish identity, quality, biological activity or clinical suitability.
Document tissue source, donor, immunophenotype, passage, viability and culture history.
Record medium, supplements, cell density, oxygen conditions, priming and collection duration.
Measure total protein as one compositional parameter without treating it as proof of potency.
Evaluate selected cytokines, chemokines, growth factors or enzymes relevant to the proposed mechanism.
Assess particle concentration, size distribution, morphology and selected EV-associated components where relevant.
Evaluate media proteins, supplements, aggregates and process-related materials.
Assess sterility-related parameters, mycoplasma and endotoxin where applicable.
Use a fit-for-purpose assay linked to the proposed immunological, trophic, vascular or tissue-support mechanism.
Establish the effects of formulation, storage, transport, holding time and freeze–thaw exposure.
MSC secretome, conditioned medium, purified exosomes, small extracellular vesicles and exosome-depleted conditioned medium describe related but distinct biological materials.
The MSC secretome is not “differentiated.” Source MSCs may be primed, preconditioned or lineage-directed, but the secretome itself is collected and processed.
A secretome preparation is not inherently sterile, standardised, patient-specific or suitable for clinical administration merely because it originates from MSCs.
Laboratory activity, animal research or preliminary human data do not independently establish safety or clinical effectiveness.
Potential applications in orthopaedics, neurology, immune-mediated disease, wound care, dermatology, pulmonary disease or organ injury remain investigational unless supported by product-specific clinical evidence and applicable authorisation.
Establish MSC identity, tissue origin, donor, passage, viability and culture history.
Standardise medium, supplements, oxygen, cell density, priming conditions and collection period.
Distinguish complete secretome, conditioned medium, EV-enriched material and EV-depleted soluble fractions.
Evaluate relevant soluble proteins, vesicles, residual media components and process-related materials.
Use mechanism-relevant assays rather than relying solely on total protein, particle count or marketing terminology.
Define whether the preparation is for research, patient-linked development or a standardised medicinal-product programme.
Review addressing soluble and vesicular secretome components and potential applications in respiratory, hepatic and neurological disorders.
View publicationFrontiers in Immunology. 2018;9:2837.
View publicationCytokine & Growth Factor Reviews. 2019;46:1–9.
View publicationCell Stem Cell. 2012.
View publicationStudy demonstrating source- and donor-associated differences in secretome protein composition.
View publicationSystematic review of clinical parameters associated with wound-repair applications.
View publicationRegulatory and patient-safety information concerning unapproved regenerative-medicine products.
View FDA informationQuality, nonclinical and clinical considerations relevant to medicinal products using stem cells as starting material.
View EMA guidancePhysicians, researchers and institutions may request information concerning MSC source-cell systems, secretome production, fractionation, characterisation, functional assays and scientific collaboration.