We always strive to elevate the natural biologic industry. We have seen the benefits that these products have had firsthand, and we are proud to continue supporting therapies with safe and effective results for patients everywhere.
As part of our commitment, we are proud to introduce a new product in our suite of offerings: Cytosomes.
What are Cytosomes?
Cytosomes are clinical-grade extracellular vesicles (EVs) derived from amniotic fluid. These small, membrane-bound EVs are the great communicators of the body. When cells signal in a paracrine fashion, Cytosomes use EVs to package and transmit the messages. Not all amniotic fluid is the same. The difference lies in the source material, quality of the processing technique, particle size, concentration, and protein and ribonucleic acid (RNA) concentration.
That’s what makes Cytosomes so unique.
Safely Processing Cytosomes
Cytosomes are released by the developing fetus, placenta, and mother into the amniotic fluid (AF). The AF is procured from consenting healthy, carefully screened, and tested mothers at the time of a scheduled cesarean section. The recovery process is performed by tissue banks accredited by the American Association of Tissue Banks (AATB) following the stringent guidelines enforced by the Food and Drug Administration (FDA) and the Center for Disease Control (CDC). The FDA prohibits manufacturers from making claims about their product’s ability to treat specific health conditions. As a manufacturer, we encourage customers to research and determine whether Cytosomes are right for their research and clinical trial needs. Cytosomes are manufactured following cGMP guidelines in an FDA-registered laboratory.
What are Extracellular Vesicles?
Extracellular vesicles (EVs) are lipid bilayer-enclosed, cytosol-containing spheres that are released by all eukaryotes and prokaryotic cells into the extracellular environment. Primarily, EVs act in cell-to-cell communication. When cells communicate in a paracrine fashion, they use EVs to package and transmit the messages. Cystosomes are produced to the highest standards to retain the integrity of their cargo.
The Clear Difference
Not all amniotic fluid is the same. The difference lies in the source material, quality of the processing technique, particle size, concentration, and protein and ribonucleic acid (RNA) concentration. With our unique processing technique, Cytosomes are crystal clear, never pink, and never cloudy, which may compromise outcome data.
Other benefits of this natural biologic include:
- Cytosomes are produced on-site by highly trained scientists at the Neobiosis cGMP compliant laboratory in ISO 7 cleanrooms.
- Each 1cc of Cytosomes contains an average of 250 billion (+/- 100 billion) EVs.
- Cytosomes particle size is consistently between 50 – 150 nm.
- Cytosomes are twice sterile filtered, which maintains the biological integrity of RNAs.
- Sterility is validated by a qualified and independent CLIA certified lab.
Are you interested in integrating Cytosomes or another natural biologic product into your care continuum? Join one of our webinars here to learn more. Dr. Singer founded David Singer Enterprises, that has been consulting clinics for over 30 years. By following his program, healthcare professionals have been able to help more patients while having their staff do more of the work and therefore enjoy more free time for themselves. One of his major goals is to see that regenerative medicine has the greatest impact possible in society.
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