Cytosomes are small, membrane-bound extracellular vesicles released by the developing fetus, placenta, and mother into the amniotic fluid. Extracellular vesicles (EVs) primarily act in cell-to-cell communication, assisting in the natural regenerative process. Cytosomes are the great communicators in the body. When cells signal, they use EVs to package and transmit the messages.
The amniotic fluid where our cytosomes are sourced is twice sterile filtered, which maintains the biological integrity of RNAs, ensuring the highest quality product.
No, amniotic fluid flowable products differ in the source material, quality of manufacturing, sterilization technique, particle concentration, protein and RNA concentration, and potential risk of fungal and bacterial contamination.
The Cytosomes product is crystal clear. It’s never pink and never cloudy – factors that may inhibit the biological process. Cytosomes are twice sterile filtered and never UV irradiated, protecting the integrity of the RNA. These processes follow the highest possible standards to retain the integrity of bioactive cargo.
Cytosomes are harvested from amniotic fluid collected by AATB accredited tissue banks following FDA and CDC guidelines during full-term, healthy Cesarean births with maternal consent.
The purified amniotic fluid donors for our Cytosomes product are screened, qualified, and tested for infectious diseases as required by FDA, CDC, and WHO.
Learn About Our Product Sourcing Process
Cytosomes are produced onsite by highly trained scientists in cGMP-compliant, FDA-registered, ISO 7 cleanrooms.
- The Purified Amniotic Fluid for our Cytosomes product has a particle size consistently between 50-150 nm and sterility is validated by a qualified, Independent, CLIA-certified laboratory.
- Each 1 ml vial of Purified Amniotic Fluid contains an average of 250 billion (+/– 100 billion) EVs.
- Purified Amniotic Fluid contains over 300 major proteins and growth factors that stimulate many biological functions.
Cytosomes serve various functions within a clinical setting, including:
- Tissue Regeneration & Wound Healing
- Vascular & Angiogenesis
- Antimicrobial Activity
- Stem and Progenitor Cell Activation
- Immune Modulation