Since the discovery of stem cells and their function within the human and animal body, research has advanced at a rapid rate, leading to new discoveries regarding the nature and function of these cells.
As research has advanced, numerous types and sources of stem cells have been identified and suggested for use in providing the greatest potential medical benefits. As each type, source and potential usefulness in providing medical solutions has been explored, the overriding conclusion has been postulated that the greatest potential medical solution will result from the identification and ability to recover a therapeutic quantity of stem cells that are: (i) “pluripotent,” which means that they can produce progenitor cells capable of repairing all types of tissues in the body; (ii) “non-tumorigenic”, which means they do not form tumors, when injected into the body; and (iii) “non-Immunogenic,” which means that they can be used by both the individual from whom the stem cells were recovered and any other individuals, without fear of an immune response and rejection.
To date, a number of sources and types of stem cells with various “potencies” have been suggested and tried, including:
Embryonic Stem Cells (“ESC”), which, upon testing, proved interesting and pluripotent, but not useful, due not only to ethical objections, but also the fact that they produced a tumor.
Adipose Tissue Derived Stem Cells (“ASC”), which are mesenchyme stem cells (“MSC”) recovered from a person’s fat tissue, have also proved interesting and continue to be used by health care providers in a number of markets. However, current and compelling scientific evidence now suggests that the therapeutic mechanism of action of mesenchyme stem cells (MSCs) and therefore their therapeutic potency results not in their ability to differentiate into their target tissue but rather in their secretory paracrine growth factors, cytokines and exosomes that lead to tissue repair and immuno-regulatory effects.
Despite the well documented therapeutic potency of MSCs resulting from their demonstrated ability to secrete multiple factors critical to tissue repair and immuno-regulation, the use of autologous and allogeneic human MSCs for live cell therapy has posed a number of challenges, including: invasiveness, uncontrolled dosing, cross-contamination, side-effects including immune reaction, limited viability, cost to manufacture and complicated manufacture and delivery logistics.
However, recent studies have demonstrated that due to comparable effects, along with superior safety, MSC conditioned medium (“MSC-CM”), containing a complex of MSC-secreted factors, should be considered a reasonable alternative to MSC live cell therapy.
Induced Pluripotent Stem Cells (“IPSC”), which are unipotent cells (capable of producing a single tissue type progenitor cell), initially derived from skin that are genetically reprogrammed from their unipotentcy into pluripotent cells, capable of producing progenitor cells of all types of tissues. Of late, a tremendous amount of research and expenditure has gone into this process of reprogramming unipotent cells, with the primary obstacle being that they, like the ESC, produce a cancer tumor and are expensive to produce.
Tithon's science team, following years of research, have discovered a population of cells in human peripheral blood that are pluripotent, easy to isolate, and abundant within human and animal peripheral blood. Upon discovery, Tithon's science team developed a proprietary method, process and procedure for recovering therapeutic quantities of these cells from a simple blood draw. Repeated lab testing has revealed these cells are pluripotent and non-tumorigenic and possess all four of the "Yamanaka Factors" . Tithon's science team has labeled these stem cells it is capable of recovering in abundant quantities from peripheral blood, utilizing its proprietary methods and processes, “Naturally Occurring Pluripotent Stem Cells” or “nPSC” and has labeled the proprietary method, process and procedure it has developed to recover these cells as its “nPSC Technology.”
nPSC Applications. Tithon's science team has demonstrated that the nPSC, recovered utilizing the nPSC Technology, provide a breakthrough new potential for human and animal: cell banking, diagnostics, therapeutics and tissue engineering - including the in vitro production of 3D organoids commercialized through a bio bank. This has been substantiated through the utilization of the nPSC in both human and animal therapies, addressing a number of medical conditions, with significant positive results reported.
Tithon's science team has recently sponsored the completion of further laboratory testing of peripheral blood drawn from independent sources to verify the presence and pluripotency of the nPSCs, initially discovered and tested for pluripotency by Tithon's science team.
Testing was performed at the Democritus University of Thrace, Dragana, Alexandroupolis, Greece, under controlled conditions, utilizing embryonic materials as the positive control.
As verified by the testing performed by the research team at Democritus University of Thrace, this discovered population of cells range between 1 to 5 million cells per ml of plasma, are relatively small in diameter (<5um), express all four Yamanaka factors (OCT4, SOX2, MYC, KLF4), stain positive for the Kyoto Probe (KP-1), and express Nanog, CD133, CXCR4, SSEA3 and SSEA4.
The results of testing unequivocally demonstrated both the presence of the nPSCs in human peripheral blood and their pluripotency.
This data, which verified data derived from testing that was previously done in-house by Tithon science team, provides the basis for submitting to global regulatory authorities evidence of a new and highly valuable source of pluripotent stem cells for use in advancing reviewed and approved therapeutic, diagnostic and tissue engineering uses of the nPSCs.
In addition to demonstrating that the nPSCs possess all of the markers for pluripotency and the existence of the Yamanaka Factors, Tithon's science team has successfully demonstrated the ability to differentiate the nPSCs, recovered utilizing the nPSC Technology, into: osteoblasts (bone), chondrocytes (cartilage), dermal papilla (hair) oocytes (primitive ovum) and cardiomyocytes (heart) through proprietary culture media. Tithon's research team is continuing to perform laboratory research aimed at discovering additional characteristics and potential of the cell population recovered utilizing the nPSC Technology.
As a further step in demonstrating the pluripotent nature of the nPSCs, the Tithon science team has undertaken the production of 3D organoids utilizing the nPSCs recovered utilizing the nPSC Technology.
· Cryopreservation of nPSCs by purchasers and donors for future therapeutic use by the depositing customer or by individuals seeking donor sources
Processing of submitted peripheral blood for recovery of nPSCs for immediate use in addressing various degenerative medical conditions
In vitro production for personalized 3D organoids from nPSCs for autologous and allogeneic diagnostic and therapeutic use
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