Golden, Colorado—September 9, 2014—Vitro Diagnostics, Inc. (OTCQB: VODG), dba Vitro Biopharma announced the publication of a research study using its stem cells to treat an animal model of stroke. University of Illinois College of Medicine at Peoria (UICOMP) researchers, led by Dr. Krishna Kumar Veeravalli recently published a study showing a prominent reduction in brain damage by treatment of an animal model of ischemic stroke with human MSCs obtained from Vitro Biopharma through its distributor Neuromics, Inc. The study focused on several measures of brain damage by apoptosis, or programmed cell death that resulted from occlusion of the rat carotid artery, an animal stroke model. Death of brain cells leads to paralysis, loss of function, cognitive impairment, and other effects following a stroke. Hence, reversal of cell death can reverse several adverse neurological effects of stroke. Following the intravenous injection of 250,000 or 1,000,000 Vitro Biopharma’s human umbilical cord blood-derived MSCs, there was a dramatic and statistically significant reduction of cellular apoptosis compared to untreated groups. The endpoints included DNA damage and expression levels of numerous genes known to be associated with apoptosis. (Neurochem Res 39: 1511-1521, 2014)
Treatment with the minimal levels of Vitro Biopharma’s hMSCs, that were expanded in MSC-Gro™, our proprietary MSC cell culture growth medium, reverted the expression of several apoptosis-related genes to the normal levels. Over 40 different genes known to activate apoptosis were down-regulated (2 to over 30-fold). MSC treatment also reduced expression of about 20 genes that inhibit apoptosis including Bcl 2. The authors suggest this may be secondary to the down-regulation of activating genes through the regulatory processes controlling apoptosis. This study is supported by other research showing neuroprotective effects, reduction of infarct size and improvement of neurological recovery by MSC transplantation in various models of animal stroke. The authors conclude that treatment of ischemic stroke by MSCs that regulate multiple different molecules leading to cell death offers therapeutic advantage over other strategies targeting only select molecules that regulate cell death.
Stroke is a prevalent medical condition affecting the global community. According to the NIH, there are 795,000 stroke cases per year in the US, stroke is the 4th leading cause of death and it results in more serious long-term disabilities than any other disease. Furthermore, the risk of stroke increases 2-fold for every decade of beyond age 55. Given the aging population, stroke incidence is highly likely to increase. The current standards of treatment involve early diagnosis and treatment of strokes due to blood clots lodging in the brain with clot dissolving enzymes within a three-hour window from the onset of symptoms to reverse cerebral ischemia. However, only three to five percent of those who suffer a stroke reach the hospital in time to be considered for this treatment. Moreover, about half of the patients receiving this therapy show little or no improvement in functional outcome. In addition, treatment with clot dissolving enzymes present real safety concerns because of the increased incidence of secondary hemorrhagic transformation and the increased mortality rate in patients who have bleeding disorders.
Dr. Jim Musick, Vitro Biopharma’s President & CEO said, “We are pleased that our products were used in Dr. Veeravalli’s research showing strong pre-clinical efficacy of stem cell therapy for treatment of ischemic stroke. Her team’s impressive and detailed study of the effects of MSC transplantation on the reversal of cell death adds to the growing body of evidence regarding treatment of neuro-degenerative diseases with adult stem cells. We are currently involved in an early stage clinical trial of traumatic brain injury and have trials of autism spectrum disorders ongoing through our European business partner Dr. Josef Smarda. The impressive evidence gathered by Dr. Veeravalli and her associates clearly demonstrates a dramatic reduction in apoptosis by stem cell therapy. This adds to prior evidence showing that stem cell transplants and/or activation can mitigate cerebral inflammation, provide neuroprotective effects, reduce oxidative stress and stimulate angiogenesis in addition to the well-known neurogenesis of stem cells. All of these biological processes are important to recovery and regeneration following injury or disease of neurological systems. The data being generated through independent investigation by several groups re-enforces the need for clinical studies that are also tied together with detailed pre-clinical and in-vitro studies to support and direct the clinical trials. Vitro Biopharma has developed advanced in-vitro cell based assays of stem cell activation, including cell migration, proliferation and epigenetic reprogramming that may be extended to patient-specific stem cells. Through our collaborative network of experts we are extending the application of stem cell therapy to neurological disorders through evidence-based medicine based on stringent validation and quality requirements.”
About Vitro Biopharma
Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG; https://vitrobiopharma.com), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. In 2011, Vitro Biopharma out-licensed its intellectual property related to treatment of infertility to Dr. James Posillico, a renowned expert in Assisted Reproductive Technologies. Vitro Biopharma also owns a pending patent for methods of mesenchymal stem cell (MSC) generation and related materials. Vitro Biopharma’s mission is “Harnessing the Power of Cells™” for the advancement of regenerative medicine to its full potential. Vitro Biopharma operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro Biopharma manufactures and sells “Tools for Stem Cell and Drug Development™”, including human mesenchymal stem cells and derivatives, the MSC-Gro™ Brand of optimized media for MSC self-renewal and lineage-specific differentiation. In addition to our FSH patent licensee, Vitro Biopharma maintains several strategic partnerships including an alliance with Neuromics, Inc. (www.neuromics.com). Neuromics, Inc. is a primary distributor of Vitro Biopharma products and a well established manufacturer and distributor of a large variety of life science research products especially focused on cell-based assay systems We jointly manufacture stem cell assay systems with HemoGenix®, Inc. (http://www.hemogenix.com/), known as the MSCglo quantitative assay for determination of MSC quality, potency and response to toxic agents. Also, Vitro Biopharma’s CEO is a consultant on an NSF grant at the City College of New York to advise Dr. Lane Gilcrest, Professor of Materials Science and Engineering, and his colleagues regarding the development of novel extracellular materials for use in self-renewal and differentiation of mesenchymal stem cells.
Vitro Biopharma received the Frost and Sullivan Technology Innovation Leadership Award for the industry sector: Stem Cell Tools and Technology in North America, 2014.
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Dr. James Musick
Chief Executive Officer
(303) 999-2130 Ext. 3
Source: Vitro Diagnostics, Inc.