Stem Cell Technology
Vitro Biopharma has extensive experience in developing cell-based biological products and is presently focused on adult stem cells known as mesenchymal stem cells or MSCs. The discovery of embryonic stem cells capable of differentiation into any cell type of the body was largely responsible for the development of modern stem cell technology. Embryonic stem cells are also ethically contentious since, in certain cases, embryo destruction results from the use of embryonic stem cells. However, adult stem cells are derived through non-destructive procedures from a variety of tissue sources. Adult stem cells have been approved for clinical use for over 50 years and have a strong record of safety and efficacy for use in the treatment of numerous blood disorders and immunological conditions. Presently, the MSC sector of stem cell research is one of the most rapidly growing and expanding fields within the entire stem cell industry.
The rapid emergence of stem cell products & technology based on MSCs is related to several factors including the widespread availability of these cells from numerous tissue sources and the strong clinical results showing widespread efficacy and safety in a broad range of indications within disease treatment, recovery from injury and accelerated healing as well as numerous applications in regenerative medicine. Also, MSCs may be modified in specific ways to render these cells effective in treatment of other conditions including cancer. While the clinical effectiveness of MSCs is related to replacement or regeneration of specific cells types, their application in the treatment of cancer is related to another property of MSCs which is the ability to home to specific sites within the body and physically move to those regions through a complex system of chemical signals, receptors and chemotactic movement of MSCs to these sites. MSCs are known to migrate and home into regions of inflammation or to cancer stem cells. Cancer stem cells are thought to be responsible for cancer tumor growth and especially to resistance to chemotherapy and radiation. These cells may thus lay dormant for long periods of time after cancer treatments only to form malignant tumors later and thus give rise to relapse or metastasis. MSCs are being developed for the specific delivery of toxic molecules to cancer stem cells as a new novel method for treatment of cancer including those with high morbidity and resistance to traditional therapies.
Our stem cell products and technology are based upon MSCs. We offer basic tools to support stem cell research and clinical studies of MSCs. Our products include both native MSCs and various derivatives, specialty cell culture media for support of growth and differentiation of MSCs and measurement tools for the determination of potency, quality and the response of MSCs to toxic agents. Our MSC cell lines include native cells, fluorescent-labeled MSCs for use in tracking studies and in-vivo imaging experiments together with native fibroblast cells and transfected MSCs for use in studies of reprogramming of adult cells to gain functional properties of embryonic stem cells. Recent research has shown that skin cells known as fibroblasts, can be reprogrammed to exhibit properties of embryonic stem cells, including the ability to differentiate into any type of cell by the over-expression of four different genes (Myc, Oct 3/4, Sox 2 & Klf4). The pioneering research underlying the reprogramming of differentiated cells into pluripotent cells conducted by Drs. JB Gurdon and S Yamanaka led to the award of the 2012 Nobel Prize in Physiology or Medicine, for the paradigm-shifting discovery of the reprogramming of differentiated cells, which was not previously thought to be possible.
Additional research by Vitro Biopharma and others has shown that over-expression of just a single gene in adult stem cells is sufficient to induce the pluripotent state (ability to differentiate into any cell type) thus considerably simplifying the process of reprogramming to achieve the functional properties of embryonic stem cells. This research area is thus related to expanding the capabilities of adult stem cells to include the basic properties of embryonic stem cells.
The image shown here shows Vitro Biopharma’s research of human MSCs subject to a re-programming protocol involving exposure to small molecules (valproic acid & azacytidine) together with reduced O2 to induce the pluripotent state through induced expression of endogenous Oct 3/4. The arrows indicate putative iPSCs (induced-pluripotent stem cells) ~ 5 micron in diameter resulting from this treatment. Vitro Biopharma has a pending US Patent application regarding its technology for iPSC induction through use of small molecules and environmental parameters without the necessity of transfection to induce the pluripotent state. We are interested in strategic collaboration to further develop this intellectual property.
Our MSC cell culture media, known as the MSC-Gro™ Brand is optimized to support growth and differentiation of MSCs. This media shows strong competitive advantages over media provided by other commercial supplies, including an increased rate of growth that yields 2-3-fold greater numbers of cells in culture, together with increased quality and potency of the MSCs. Also, our unique formulation is much more stable than competitor’s media allowing for storage for over one year at 2 to 8oC. We also provide additional formulations for use in the culture of various primary cells including neurons, hepatocytes, fibroblasts and certain cell lines (HEK293A and the rat cardiomyocyte cell line, H9C2). Our media is provided as serum-containing and serum-free as well allowing customers to utilize chemically-defined, serum-free media for clinical applications including expansion of MSCs and production of biotherapeutic products from genetically engineered cells. We also offer powdered formulations that afford cost-effective shipment to offshore customers.
Our products also include highly sensitive assays of MSC quality, potency and response to toxic agents. These products are jointly manufactured by Vitro Biopharma and HemoGenix, Inc located in Colorado Springs, CO. These products include our MSC-Gro™ brand of MSC media together with a patented read-out system for accurate and highly sensitive measurement of cellular ATP content. This is based on the well-known HALO® assay platform used for high sensitivity analysis of hematopoietic stem cells. Since ATP is used for all energy requiring functions of cells, its precise measurement is an excellent indicator of cellular functionality including proliferation and differentiation capacity. The most sensitive assays depend on bioluminescent read-out and we have recently added both fluorescent and absorbance-based cellular functionality assays.
In addition to our commercially available products, Vitro Biopharma also owns proprietary intellectual property related to specific inventions and medical applications. We own patents related to treatment of infertility through the production and purification of the pituitary hormone, FSH which is a well-known fertility drug that has been used since the 1960’s to treat infertility. During 2011, Vitro Biopharma entered into a license agreement with Dr. James Posillico, a world renowned authority in women’s health care, covering the Company’s intellectual property related to treatment of infertility. The Company also owns an issued US Patent for a stem cell line with application to treatment of diabetes in humans and animals. This technology is at advanced preclinical levels and is available for partnering into commercial products. Vitro Biopharma also owns a pending patent application related to novel methods for generation of induced-pluripotent stem cells from adult stem cells, as described above and additional proprietary technology for formulation of chemically-defined, serum and animal-component free cell culture media together with other technology related to clinical applications of MSCs.