EXOVEX
Post Procedure Skin Care and Hair Care
Exovex is designed to be applied topically in conjunction with facial or scalp microneedling, and energy based aesthetic devices to accelerate recovery time and enhance treatment results. It synergistically improve the appearance of discoloration, tone, texture, and fine lines.
Exovex aesthetic skincare serum can reduce post procedure downtime and burning sensation and may reduce the signs of aging caused by the stress of modern living for all skin types, every time!
EXOVEX
- Exovex is a placental MSC stem cell-derived exosomes product containing isolated and concentrated exosomes suspended in 0.9% saline.
- Each Exovex lot is tested for sterility as per <USP 71> and endotoxin as per <USP 85>, and sterile filtered through 0.22.m (micron) pore membrane filtration.
- Exovex stem cells are procured from young, healthy donors who have been tested negative for communicable diseases, such as HIV I/II, Hepatitis B, Hepatitis C, HTLV I/II, Syphilis, CMV, West Nile Virus, Zika virus, and screened for other pathogens.
- Exovex exosomes are characterized quantitatively via Nanoparticle Tracking Analysis and Next Generation Sequencing for a full analysis of particle size and
concentration, all RNA species and all functional components present, providing the most comprehensive evaluation of safety and efficacy available anywhere in the world. - Exovex exosomes are qualitatively characterized for hundreds of growth factors and anti-inflammatory proteins, including BMP-5, GDF-15, OPG, SCF, TGFb3, VEGF, IL-1ra, IL-6, IL-10, MCP-1, MIP-1b, PDGF-BB. TIMP-1, TIMP-2, TNF RI, and more.
- Exovex is acellular, preservative-free, and manufactured with xenofree products in a cGMP facility. Manufactured in the USA with USA-sourced tissue.
- For topical use only.
Exosomes with Growth Factors and mRNA
Exosomes are isolated from the Chorion of Placental Mesenchymal Stem Cell (pMSCs)
Also known as
Exosomes are sometimes called EVs or Secretomes. They produced by signaling cells (some of which are Mesenchymal Stem Cells) upon specific physiological or environmental cues, which contain a precision payload capable of modulating the phenotype of target cells.
Mechanism of Action
Exosomes seek out specific cellular targets and, upon arriving at their intended destination, can transfer their cargo of mRNA, miRNA, and growth factors to recipient cells or activate signaling pathways in order to change the behavior of the recipient cell.
Clinical trials are already underway designed to test the hypotheses that Exosomes might serve as a therapy to alter the inflammatory response.
Early findings suggest that MSC-derived exosomes can modulate the phenotype of macrophages. This is the likely Mechanism of Action that Exosomes exert on inflammation, since macrophages play a pivotal role in regulating immune responses.
Macrophages assume both phagocytic “defensive” roles and exhibit regulatory “anti-inflammatory” actions, mediating both the initiation and resolution of inflammation.
Exosomes Vs. PRP
| Exosomes | PRP |
|---|---|
| Anti-Inflammatory Properties | No Anti-Inflammatory Properties |
| Consistent/controlled outcomes | Results vary based on age and patient condition |
| Pain-Free | Acidic in nature |
| Easy to use (no drawing blood) | 15 minutes of added prep time and additional equipment |
| 1-2 Treatments | 3-6 Treatments |
| 450 GF + Anti-Inflammatory, Micro-RNA & MRNA’s for efficacy | 7-25 GF |
| High Potency | Low Potency |
MOLECULAR CHARACTERIZATION
All EXOVEX products have undergone extensive molecular characterization including:
- PCR analysis to test for the presence of pathogens.
- Fluorescence Assisted Cell Sorting to specifically select Mesenchymal Stem Cells.
- Multidimensional Protein Identification Technology (MudPIT) to characterize and quantify the proteins present in the final specimen.
- Nanoparticle Tracking Analysis (NTA) to ascertain particle size and concentration.
The results of these tests and interpretation of the data is detailed below.
POLYMERASE CHAIN REACTION (PCR)
Each specimen was tested against an extensive panel of pathogens including HIV, Hepatitis B, Hepatitis C, HTLV, Syphilis, CMV, West Nile virus, Zika virus. This panel exceeds FDA guidelines for communicable disease testing in human tissue.
No PCR amplification was observed for any of the pathogens tested. The results of this analysis confirm that the starting material is free of all communicable diseases tested.
FLUORESCENCE ASSISTED CELL SORTING (FACS)
The cells were sorted using FACS to specifically select Mesenchymal Stem Cells prior to expansion. This level of analysis is not routinely performed prior to culture for Exosome production. All cells expressed surface molecules CD105, CD90, CD73 and CD146 and CD44 and lacked expression of CD45, CD34, CD31 and HLA-DR [1]. This analysis confirms the presence of purified MSCs prior to culture resulted in a higher yield of exosome nanoparticles.
MULTIDIMENSIONAL PROTEIN IDENTIFICATION TECHNOLOGY (MUDPIT)
Two representative samples were submitted for MudPIT [2] analysis. Comparative analysis of each specimen demonstrated a high degree of inter-batch reproducibility. In Sample 1, 387 unique human proteins were identified from a total of 2665 peptide sequences detected. In Sample 2, 401 unique human proteins were identified from a total of 3914 peptide sequences detected.
All proteins detected in each sample were cross referenced against the UniProt database [3] for functional annotation to ascertain the potential efficacy of the EXOVEX samples by understanding the biological processes of their component proteins.
The predominant proteins identified in each sample tested are consistent between the different batches tested.
NANOPARTICLE TRACKING ANALYSIS (NTA)
Two representative samples were submitted for NTA. Both samples demonstrated exceptional particle counts indicating the effectiveness of the upstream processes, in particular the proprietary culture media and the fluorescence assisted cell sorting, for producing a high
potency final product.
Two complementary techniques for estimating the size and concentration of the particles in each sample were used [4]:
- Dynamic Light Scattering which measures the intensity of fluctuations in scatteredlight.
- Fluorescent tagging where the particles are observed under amicroscope.
| Process | Safety | Efficacy | Other Products | Exovex Value Statement |
|---|---|---|---|---|
| Serology | Starting tissue confirmed negative for 12 different viruses including HIV, HPV, and HCV. | No pathogens were introduced by the starting tissue. | HIV, HPV, and HCV only. | All donor tissue is screened for pathogens and tested negative for communicable diseases. |
| FACS | No cell types other than Mesenchymal Stem Cells (MSCs) are included in downstream processes. | Only cells positive for CD90, CD105, CD73, CD146 and CD44 and negative for CD45, CD34, CD31 and HLA- DR were selected. This process ensures specific growth of desired cells. |
No cell sorting performed. |
Exovex is manufactured using one placenta per each batch of exosomes and only the chorion tissue is used to harvest MSCs. MSCs are specifically selected early in the process to ensure efficient production of uncontaminated high-fidelity and functional cells. |
| PCR | Cells confirmed negative for 20 different pathogens. | No pathogens are present in the cells. | Not routinely performed. |
All vials are confirmed to be contaminant free. |
| Culture | No contaminating cells grown in the media. | Pure exosomes are grown in a high-fidelity proprietary medium. | Use off-the-shelf medium. | Our proprietary xeno-free medium ensures efficient and specific growth of high-quality MSCs. |
| MudPIT | Confirmation that all peptide sequences present are human. All protein sequences are cross-referenced against UniProt database for functional annotation. | A large diversity of proteins is present including collagens, extracellular matrix proteins, cytokines, growth factors, and enzymes. | Not routinely performed. | Human peptide sequences represent a large diversity of functional proteins including collagens, extracellular matrix proteins, cytokines, growth factors, and enzymes are identified in each vial. |
| NTA | Confirms particle size ensuring no contamination from other cells types were introduced during processing. | Each vial of EXOVEX contains greater than the labeled concentration per volume which is quantified using light scattering. | Approximately 5-10 Billion particles/ml. | As a result of our manufacturing process, our exosomes particle count per ml is over 10-fold greater than our closest competitors proven by light scattering and fluorescent staining. |
| Sterility | Tested negative for contamination at three time points in the process: origin, post-culture and at vialing. | Confirmation of no contamination being introduced at any point in the process. | Standard Test. | We only collect exosomes less than 100 microns ensuring the filtering of bacteria, microplasma and fungus. All vials are confirmed to be contaminant free. |
| NGS | Objective independent assessment of multiple batches by a third-party provider characterizing all nucleic acid sequences detected. No non-human sequences detected (pending results). |
Pending results (A diversity of RNA species identified, covering a large range of functional groups). | Not routinely performed. | Exovex is the most comprehensively characterized product on the market using the latest technology in nucleic acid analysis. |
| In vitro Testing | No adverse effects were observed in the in vitro model. | Confirm the healing, cell migration and cellular proliferation capacity of the exosomes. Observed gene expression changes and wound closure ability (pending results). | Not tested in vitro. | Exovex is tested on lab-grown skin and proven to improve cellular proliferation, puncture wound closure and vascularization. |
Dr J Anti-Aging Clinic
7300 Sand Lake Commons Blvd Ste 227 L
Orlando, FL 32819
(407) 972-1197
drjantiagingclinic.com
info@drjantiagingclinic.com