Vitro Biopharma was formed in 1986 and originally focused on diagnostic products and services. During the 1990’s, we developed, manufactured and marketed a line of specialty biological products targeting a niche market in pituitary hormone and tumor marker diagnostic testing. While the original manufacturing methods involved the extraction and purification of products from human tissues, we also developed recombinant human proteins and patented technology of cellular immortalization, involving genetic engineering of differentiated cells to generate immortalized cell lines that maintained characteristics of differentiated cells including hormone production. This technology allows use of the cell lines as the raw material necessary for the manufacture of purified hormones instead of requiring human tissues.
In 2000, we sold the diagnostic antigen business unit to Aspen Biopharma, Inc., now Venaxis, Inc. (Nasdaq, APPY) and retained intellectual property related to cellular immortalization and purification of follicle-stimulating hormone. We presently develop and manufacture a series of products based on adult stem cell technology. These products provide basic tools suitable to a wide variety of stem cell researchers involved primarily with adult stem cells. Our products include stem cells, media and cell-based assays for use in drug discovery and development together with functional assessment of stem cells and the development of novel stem cell activators..
We are further distinguished by our focus on a type of adult stem cell known as mesenchymal stem cells, or MSCs that represents the most rapidly growing business sector of stem cell technology based on numbers of patent applications, publications and several other metrics (BioInformatics, Inc.). MSCs are readily available from a variety of tissue sources and have an ever expanding application to treatment of diseases, injury and uses in regenerative medicine. For example, MSCs are commonly derived from adipose tissue through a process of fat collection or liposuction followed by enzymatic treatment of fat to extract the MSCs. The resultant cellular preparation, called the Stromal Vascular Fraction is now subject to numerous clinical trials. Initial results suggest that SVF shows efficacy in treatment of osteoarthritis, injury to joints, ligaments and tendons. The clinical studies of SVF are at an early stage but do indicate effectiveness in the treatment of articular injury and disease while these procedures have very limited reports of adverse effects indicating safety. A further advantage of the use of SVF is that this can readily be obtained and re-administered to the donor further contributing to enhanced safety. This procedure is referred to as an autologous cellular transplant.
Our current operational strategy involves expanding market penetration of our MSC research products together with development of products and services to support clinical applications of stem cells in treatment of animal and human conditions. Our MSC-Gro™ cell culture media is now available as Clinical Grade material for use in MSC expansion prior to transplantation. There are several clinical trials ongoing now using MSC-based treatments of a variety of conditions. These studies often require expansion of stem cells prior to transplantation. Our Clinical Grade MSC-Gro™ has numerous competitive advantages for use in this application. We have recently established bulk distribution of Clinical Grade MSC-Gro™ to an off-shore customer and we intend to expand this business considerably. We are also pursuing collaboration involving the use of select terminally differentiated cells developed by Vitro Biopharma for use in preclinical toxicology screening of drug candidates. Our cells targeting this market include MSC-derived cardiomyocytes, MSC-derived neurons including a-motorneurons and dopaminergic neurons together with Nephron Progenitor Cell (NPC)-derived PTECs (proximal tubule epithelial cells) & podocytes. Our NPCs are initially derived from MSCs prior to terminal differentiation into the functional cells of the kidney. Thus our products enable cell-based assays of cardiovascular, neural and kidney toxicity. When combined with hepatocytes, this provides an in-vitro ADMET screening process that not only determines direct drug toxicity but also allows determination of the toxicity of drug metabolites.
We are establishing clinical trials for the treatment of neurological conditions. This is supported by numerous studies suggesting stem cell efficacy in the treatment of stroke, ALS, and traumatic brain injury/concussion. We are nearing approval of our first US-based clinical trial for treatment of TBI/concussion and hope to begin patient recruitment during the summer of 2015. TBI affects 1.5 million people a year in the US only and lacks effective therapy, now relying predominantly on physical therapy/rehabilitation. Our trial will test novel diagnostics for recovery of brain function by the activation of stem cells residing within the brain.
We also have a proprietary cell line with application to treatment of skeletal muscular conditions in horses. This cell line has now advanced through all pre-clinical studies and we anticipate on-set of clinical trials of this cell line in late 2015. We are targeting tendonitis treatment as the primary indication. Tendonitis is common among sporting horses and often leads to discontinuation of racing or other competition during to lack of functional recovery. Stem cell therapy has been shown to result in functional recovery and resumption of competitive activities.
Management Team, Directors, and Scientific Advisory Board
Vitro Biopharma is the proud recipient of the 2014 Frost & Sullivan Stem Cell Tools and Technologies Industry Technology Innovation Leadership Award. Click here to learn more.