97% Proteins Preserved2
- Growth Factors
- Extracellular Vesicles
- Hyaluronic Acid (HA)
THE COMBINATION OF EV’S CAN DELIVER
these signals 3,4,5
- Immune Priviledge
Isolating the therapeutic signals released by regenerative cells, and using them rather than the cells themselves are the next generation as a therapy. The targeted cells will react to these messaging signals and will change their behavior accordingly. There is a tremendous therapeutic potential of extracellular vesicles and nano-particles.
Maximum Safety & Quality in Every Batch
- Sterile filtered without radiation
- No cryoprotectant or dilutants ever used
- Endotoxin and USP <71> testing on all lots
- Non Expanded/Non Cultured
- 100% pure natural allogenic secretion
- Non-nucleated cell
- Minimal Manipulated
- Manufactured under cGMP standards
Extracellular Vesicles Validation
Organicell™ Flow contains approximately 400 billion Extracellular Vesicles per milliliter quantified in every batch by Nanosight technology. Extracellular Vesicles are nanovesicles that contain protein and microRNA that can be transferred to other cells to support tissue repair and homeostasis.6.7
ACELLULAR - STERILE
Quality Compliance & Donor Screening
Organicell™ Flow is procured and processed in the United States according to standards and regulations established by the United States Food & Drug Administration (FDA). Donors are screened and qualified under FDA regulation 21CRF 1271. Donor ethics and non-reactive FDA approved serological screening includes but not limited to:
- Donor consent prior to collections
- HCV (Hepatitis C Antibody)
- HBsAG (Hepatitis B Surface Antigen)
- HIV 1/11-Ab (HIV Nucleic Acid Test)
- HBcAb (Hepatitis B core Antibody)
- HCV NAt (HCV Nucleic Acid Test)
Extracellular Vesicles are cell-derived nanoparticles that play a pivotal role in cell-to-cell communication and are involved in a wide range of physiological processes. They have an important role in the transfer of proteins, mRNA, miRNA and other bioactive molecules between cells and regulate gene expression in recipient cells, thus influencing various molecular pathways.
CLINICAL SUPPORT - REQUEST INFORMATION
ORGANICELL FLOW IS BEING USED FOR IND-IRB APPROVED CLINICAL TRIALS
1. (Quantitative enzyme-linked immunosorbent assay) Pierce et al. Collection and characterization of amniotic fluid from scheduled C-section deliveries. Cell and Tissue Banking; 2016 17: 413.
2. (Post-processing characterization of amniotic fluid) Pierce et al. Collection and characterization of amniotic fluid from scheduled C-section deliveries. Cell and Tissue Banking; 2016 17: 413.
3. Burrello, J., et al. (2016). “Stem Cell-Derived Extracellular Vesicles and Immune-Modulation.” Front Cell Dev Biol 4: 83.
4. Kishore, R. and M. Khan (2016). “More Than Tiny Sacks: Stem Cell Exosomes as Cell-Free Modality for Cardiac Repair.” Circ Res 118(2): 330-343.
5. Kishore, R. and M. Khan (2016). “More Than Tiny Sacks: Stem Cell Exosomes as Cell-Free Modality for Cardiac Repair.” Circ Res 118(2): 330-343.
6. Reems J. “Amniotic fluid: Thicker than water.” Perinatal Stem Cell Society Congress, 2 March 2018, The Leonard Museum, Salt Lake City, UT
7. Thery Clotilde, “Exosome Explosion” The Scientist, 2011, www.the-scientist.com/?articles.view/articleNo/30793/title/Exosome-Explosioni.html