GOLDEN, CO / ACCESSWIRE / August 8, 2017 / Vitro Diagnostics, Inc. (OTC PINK: VODG), dba Vitro Biopharma, announced initial results of a Phase I clinical trial testing the effects of its proprietary stem cell activation compounds for safety and efficacy in autistic patients. Safety was the primary endpoint of our non-randomized, pilot study and our preliminary data indicate a low incidence of adverse events, < 1.0%. Efficacy was a secondary endpoint, and the results suggest effectiveness in behavioral improvements, including speech, socialization and reduced agitation. Also, more quantitative measures showed improvement as well, including hearing improvement and biomarker profiling of inflammatory cytokines.
The study was conducted by Vitro Biopharma's Eastern European partner, Dr. Josef Smarda in collaboration with Neuromics, Inc. Over 25 patients were included during a 3 ½ year period with most patients showing comparable results. These results are now being more thoroughly analyzed and we are developing additional trials to substantiate and expand these results through randomized, placebo-controlled trials.
Dr. Jim Musick, Ph.D., President and CEO of Vitro Biopharma said, "These results support further study of the role of stem cells in the therapy of autism spectrum disorders (ASD). Stem cell therapy occurs through transplants of stem cells and/or activation of stem cells present within the body. While this trial focused on stem cell activation therapy, transplants may also be effective. Recent studies of genes associated with ASD (Nature Neurosci 3-7-2017) support epigenetic mechanisms since a majority of the gene mutations associated with ASD are in molecules that control genetic expression. An effective therapy of ASD is likely to involve resolution of epigenetic issues combined with the numerous regenerative effects stem cells on the nervous system."
About Vitro Biopharma
Vitro Biopharma's (http://www.vitrobiopharma.com/) mission is "Harnessing the Power of Cells™" for the advancement of regenerative medicine to its full potential. Vitro Biopharma operates within a modern, GMP-compliant biotechnology manufacturing and R&D 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. Our cell lines also include cancer-associated fibroblasts (CAFs) derived from lung, colorectal, ovarian, uterine, breast, and pancreatic tumors. In addition, we provide MSC-derived progenitor cells, including neural stem cells (NSCs), nephron progenitor cells (NPCs) as well as a growing line of terminally differentiated cells: cholinergic and dopaminergic neurons, osteoblasts, chondrocytes, cardiomyocytes, and renal tubular epithelial cells. An application of these terminally differentiated cells is cell-based assays for drug discovery and pre-clinical toxicology of drugs, drug candidates and drug combinations that may produce toxic effects on cardiac, neural or renal cells, either directly or through metabolites derived from the interaction of drugs with specific cells such as liver cells. Vitro Biopharma also developed its Clinical Grade MSC-Gro™ Media for expansion of stem cells prior to transplantation for clinical studies of osteoarthritis treatment and products for use in studies of stem cell activation therapy for ASD & autoimmunity.
Vitro Biopharma received the Frost and Sullivan Technology Innovation Leadership Award for the industry sector: Stem Cell Tools and Technology in North America, 2014.
Mission Statement: "As a leader in stem cell technology we manufacture and distribute multiple stem cell therapies for the treatment of degenerative diseases."
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CONTACT:
Dr. James Musick
Chief Executive Officer
Vitro Biopharma
(303) 999-2130 Ext. 3
E-mail: [email protected]
SOURCE: Vitro Diagnostics, Inc.