IRVINE, Calif., June 11, 2015 /PRNewswire/ -- NuGene International, Inc. ("NuGene") (OTCQB: NUGN), a developer, manufacturer and marketer of advanced skin and hair care lines utilizing adipose derived human stem cells and stem cell media, has announced that it is initiating a study that will allow NuGene to evaluate a medication formulation as an improved method of treating burn wounds.
The study, named Comparison of an Allantoin Formulation and Allantoin Formulation with Conditioned Media of Adipose-Derived Stem Cells on Wound Healing after Ablative Fractional Carbon Dioxide Laser Resurfacing Protocol, will begin immediately and is scheduled to run through September 1, 2015 but may be extended if necessary.
NuGene will provide the investigational new drug to be used in this study. The study will compare the effect of using Allontoin, a natural chemical compound that is produced by many organisms and is commonly used as an ingredient in skin care products, both with and without NuGene's proprietary conditioned media of adipose-derived stem cells.
This study is intended to expand upon previously published studies, specifically The Effect of Conditioned Media of Adipose-Derived Stem Cells on Wound Healing after Ablative Fractional Carbon Dioxide Laser Resurfacing (2013 Zhou, et al.). The study will follow the same methodology as in this previous study with some exceptions. There will be a pain scale administered to determine tolerability of the medicine, skin elasticity will be measured, and the medications will be applied three times a day to increase bio-availability, mimicking the real world use of a topical skin protectant.
The test subjects will receive superficial laser resurfacing on their forearms, and some subjects will receive the Allontoin with the stem cell derived media and some without. Both subjects and researchers will be blinded in the study (they will not know who is receiving the Allontoin with the stem cell derived media). As opposed to the previous study, the medication treatments will be applied three times per day, and will be tested for fibroblast growth factors, karatinocyte growth factors, vascular endothelial growth factors, platelet-derived growth factors, and hepatocyte growth factors. All of these may contribute to more efficient wound healing.
"As we have previously discussed, our NuGene BioPharma division is moving ahead with necessary research and testing to begin the work of bringing new products to market," said NuGene CEO Ali Kharazmi when announcing the study. "While our cosmeceutical products provide us with substantial opportunities, we are first and foremost a science-based company. Our goal is to advance standards of care across a number of human conditions, and we have identified wound and burn care as a top priority."
To avoid any potential conflicts of interest, evaluation of the data will be completed by the Nanjing Regenerative Medicine Engineering and Technology Research Center and the medical photographs will be rated by independent dermatologists. NuGene will be submitting an 8K filing with the SEC in conjunction with this public release of information.
About NuGene International, Inc.
NuGene International, Inc. specializes in developing, manufacturing and marketing proprietary regenerative cosmeceutical and pharmaceutical products based on adipose derived human stem cell and human stem cell media. The US Department of Health and Human Services calls regenerative medicine the "next evolution of medical treatments." The regenerative medical market which includes cosmeceuticals and pharmaceuticals was estimated at $7.2 Billion in the US in 2014 and is expected to rapidly grow in the coming years according to RNCOS Business Consultancy Services Global Cosmeceuticals Market report. NuGene's cosmeceutical and pharmaceutical products are based on proprietary stem cell based regenerative formulations derived from non-controversial, adult human stem cell derived media obtained from adipose tissue. NuGene's exclusive products combine its in-house advancements, proprietary technologies, and patent pending formulations. The company has four patents pending covering 15 unique applications and inventions. NuGene's goal is to leverage its knowledge and expertise to develop age defying cosmeceutical skincare and hair care products in addition to pharmaceutical products based on the same regenerative science platform.
This release contains forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to the possibility that some or all of the matters and transactions considered by NuGene International may not proceed as contemplated, and by all other matters and assumptions specified in NuGene's filings with the Securities and Exchange Commission, especially those risks and other matters described under "Risk Factors" within NuGene's Form 10-Q filed with the Commission on May 15, 2015. These statements are made based upon current expectations that are subject to risk and uncertainty. NuGene does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information.
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