Technology
Extracellular Vesicles: A New Frontier in Regenerative Medicine
What are Extracellular Vesicles?
Extracellular vesicles (EVs) are nature’s communication tool to coordinate activities between cells within your body. EVs are small lipid membrane-bound particles which contain molecular signals (proteins and RNA) that act like a message in a bottle. After their release from a cell, they are received by other cells which then respond to their molecular messages. This enables the tissues and organs in your body to coordinate their response to injury and disease. EVs can be generated outside of the body (in vitro) to contain these important natural signals to restore health as well. These EVs represent an exciting new advance in regenerative medicine.
The mesenchymal stem/stromal cells (MSCs) produce regulatory proteins, such as anti-inflammatory cytokines, angiogenic growth factors, matrix regenerative signals, tumor suppressor signals, and inhibitors of apoptosis, and EVs. These EVs contain messenger RNA (mRNA), which acts as an on-switch and is translated by recipient cells into new proteins that can regulate inflammatory cells and new vessel formation, and microRNAs (miRNAs), which act as an off switch and may inhibit mRNA of chronic inflammatory cytokines and matrix catabolic enzymes. These signals work in synergy with each other and with the body to restore a natural balance.
Natural Intelligence™
Many diseases occur because of imbalances in the body’s immune response. Direct Biologics’ novel therapeutic is prepared from the secretome of human MSCs, which contain immunomodulatory activity. Direct Biologics’ proprietary cGMP manufacturing processes can mimic, enrich, and purify nature’s evolved response to restoring balance to the immune system. Unlike most drugs which are composed of only 1 or 2 molecules, Direct Biologics’ EV secretome therapies contain hundreds of different molecules that work together to assist the body’s natural healing process.
Why MSCs?
Different cell types provide unique compositions of EV messages, so it is important to understand what messages are needed to resolve the disease state. MSCs from bone marrow (BM-MSCs) are among the most well characterized cells in the body, with over 93,000 different peer reviewed publications published over the last 25 years. EVs from BM-MSCs have been reported to have a positive risk to benefit profile from many preclinical and early clinical studies for a variety of indications. BM-MSCs produce a secretome rich in EVs, cytokines and chemokines that safely regulate the natural immune response. Given the reported differences in safety, quality and efficacy of EVs from different cell types it is important for physicians to consider the cell source and properties of the specific EVs being used for treatment.
Pipeline
Our pipeline shows the progress we’re making on clinical programs currently in development using EVs to treat a wide range of diseases and conditions. To learn more about our pipeline, click here.
To learn more about Direct Biologics’ EV products, contact our team of experts today.
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