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      A Phase III, Randomized, Double-Blind, Matched-Pairs, Active-Controlled Clinical Trial and Preclinical Animal Study to Compare the Durability, Efficacy and Safety between Polynucleotide Filler and Hyaluronic Acid Filler in the Correction of Crow's Feet: A New Concept of Regenerative Filler

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          Abstract

          The Rejuran® is a new filler product made from purified polynucleotides. Here we present data from an animal study and a clinical trial to examine the durability, efficacy and safety of the Rejuran® on crow's feet. For the animal study, 25 mice were divided into three groups: Group 1 received phosphate buffered saline (PBS); Group 2 were treated with Yvoire®; and Group 3 were treated with Rejuran®. The durability and efficacy of each treatment were assessed by microscopy and staining. In the clinical trial, 72 patients were randomized to receive Rejuran® treatment for crow's feet on one side and Yvoire-Hydro® on the contralateral side, at a ratio of 1:1. Repeated treatments were performed every two weeks for a total of three times, over a total of 12 weeks' observation. All injections and observations of efficacy and safety were performed by the same two investigators. In the animal study, the Rejuran® group showed similar durability and inflammatory response to the Yvoire® group. Upon efficacy assessment, the Rejuran® group showed the greatest elasticity and collagen composition, and a significant difference in skin surface roughness and wrinkle depth. In the clinical trial, the primary and secondary objective efficacy outcome measure showed no statistical significance between the two groups, and in safety outcomes there were no unexpected adverse effects. Our data suggest that the Rejuran®, as a new regenerative filler, can be useful to reduce wrinkles, by showing evidence for its efficacy and safety.

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          The effect of PDRN, an adenosine receptor A2A agonist, on the healing of chronic diabetic foot ulcers: results of a clinical trial.

          Foot ulcer is the principal cause of hospitalization for patients with diabetes. Polydeoxyribonucleotide (PDRN), an adenosine A2A receptor agonist, improves wound healing in diabetic mice.
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            Case Reports of Adipose-derived Stem Cell Therapy for Nasal Skin Necrosis after Filler Injection

            With the gradual increase of cases using fillers, cases of patients treated by non-medical professionals or inexperienced physicians resulting in complications are also increasing. We herein report 2 patients who experienced acute complications after receiving filler injections and were successfully treated with adipose-derived stem cell (ADSCs) therapy. Case 1 was a 23-year-old female patient who received a filler (Restylane) injection in her forehead, glabella, and nose by a non-medical professional. The day after her injection, inflammation was observed with a 3×3 cm skin necrosis. Case 2 was a 30-year-old woman who received a filler injection of hyaluronic acid gel (Juvederm) on her nasal dorsum and tip at a private clinic. She developed erythema and swelling in the filler-injected area A solution containing ADSCs harvested from each patient's abdominal subcutaneous tissue was injected into the lesion at the subcutaneous and dermis levels. The wounds healed without additional treatment. With continuous follow-up, both patients experienced only fine linear scars 6 months postoperatively. By using adipose-derived stem cells, we successfully treated the acute complications of skin necrosis after the filler injection, resulting in much less scarring, and more satisfactory results were achieved not only in wound healing, but also in esthetics.
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              Clinical Evaluation of the Trophic Effect of Polydeoxyribonucleotide (PDRN) in Patients Undergoing Skin Explants. A Pilot Study

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                Author and article information

                Journal
                J Korean Med Sci
                J. Korean Med. Sci
                JKMS
                Journal of Korean Medical Science
                The Korean Academy of Medical Sciences
                1011-8934
                1598-6357
                November 2014
                21 November 2014
                : 29
                : Suppl 3
                : S201-S209
                Affiliations
                [1 ]Department of Plastic and Reconstructive Surgery, Seoul National University Bundang Hospital, Seongnam, Korea.
                [2 ]Kyung Hee University Skin Biotechnology Center, Gyeonggi Bio-Center, Suwon, Korea.
                [3 ]Pharmaresearch Products R&D Center, Seoul, Korea.
                Author notes
                Address for Correspondence: Chan Yeong Heo, MD. Department of Plastic and Reconstructive Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro 170-beon-gil, Bundang-gu, Seongnam 463-707, Korea. Tel: +82.31-787-7229, Fax: +82.31-787-4055, lionheo@ 123456snu.ac.kr
                Author information
                http://orcid.org/0000-0002-3477-7120
                http://orcid.org/0000-0001-9003-7365
                Article
                10.3346/jkms.2014.29.S3.S201
                4248006
                25473210
                0720253a-8897-4e51-a4d6-fbccea0fb13a
                © 2014 The Korean Academy of Medical Sciences.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 01 July 2014
                : 02 September 2014
                Funding
                Funded by: Ministry of Trade, Industry and Energy
                Funded by: Skin Biotechnology Center of Kyung Hee University
                Categories
                Original Article

                Medicine
                polynucleotides,polydeoxyribonucleotides,rejuvenation,wound healing
                Medicine
                polynucleotides, polydeoxyribonucleotides, rejuvenation, wound healing

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