A Platform Backed By Decades of Experience
PrimeGen has developed the stemXcell™ platform to streamline the discovery of key cytokines, proteins, and other agents required to activate or prepare Human Umbilical Cord (hUC) MSC’s to treat targeted indications.
The stemXcell™ platform enables PrimeGen to:
- Increase Potency – Deliver highly potent stem-cell therapies through the use of umbilical derived stem cells and stemXcell
- Scalable Production – Achieve unprecedented scalability with the use of allogeneic umbilical MSCs and proprietary cryoprotective methods. Human perinatal tissues, particularly umbilical cord-derived hUC-MSC stem cells are highly potent and can support multiple passages resulting in the production of billions of potent cells. PrimeGen’s proprietary cryoprotective methods allow for large-scale production, storage, and distribution of potent activated MSCs.
- Deliver targeted therapies on a disease-by-disease basis
- Improved Efficacy – Enable leaders in key markets to deliver superior and patented cell therapy solutions to large and profitable markets.
In the discovery process we collect diseased organ tissue and blood from patients to identify markers that will guide potential activation factors in order to properly prepare our hUC-MSCs for the patient-specific diseased environment. We then analyze the indication profile from the diseased organ and blood utilizing Multiplex-qPCR (Multi-Gene profile) and Multiplex ELISA (Multi-Cytokines Profile). Then choose potential activation factors from results to mimic the diseased environment of the organ or blood. We then use these activation cytokines as initial activation factors to test invitro on MSCs and eventually test in vivo in a diseased humanized mouse model for efficacy.
2. Test In-vitro
Next we test potential activation factors or combinations of activation factors with MSCs in vitro. After collecting spent media from activated cells, we test the media with a Multiplex ELISA test and analyze a large panel of potential cytokines that activated MSC’s will produce. We then determine if the expressed cytokines from the activated MSCs, are the proper effective cytokines for faster treatment or reducing the progression of diseased state. We then select the activation factors that have the best potential to reduce or impede the diseased state.
3. Test In-Vivo
In-Vivo testing of PGG activated hUC-MSCs tests a potential activation factor or factors, on the MSCs to treat a humanized mouse diseased model, in order to mimic what would happen in actual human patients. To test what could happen in a patient where the MSCs would be used to treat liver disease for example, the ‘humanized mouse’ would be safely, genetically bred with what is essentially an 80 to 90 percent human liver – a procedure pioneered by PrimeGen and the University of Southern California Medical Center and used by both in recent joint pre-clinical testing. After treating the humanized diseased mouse model with activated MSCs, our test for the efficacy of those MSCs
would consist of rigorously examining for benefits in the diseased model – specifically (a) a definite slowing of the progression of disease (deduced via histology, blood biomarkers, responsible cytokine upregulation or downregulation), (b) healing of the diseased state (using the same 3 deductive techniques), and (c) increased survivability of the diseased mouse.
Finally, we analyze the data from both the in vitro and in vivo experiments to develop a biological pathwayfor how activated MSCs are treating the diseased model. Determine and correlate that the activated MSCs produce cytokines that are responsible for the effective treatment of the humanized diseased mouse model. Use this biological pathway from our model to determine our activated MSC potency assay for later clinical use.
At this time the stemXcell platform has been utilized to discover activation agents for liver disease, diabetes, arthritis, atopic dermatitis and atherosclerosis.