Se Hwan Hwang1, Do Hyun Kim2, Bo Mi Nam3, Ji Yeon Mun3, Yong Hae Seong4, Soo Whan Kim5. 1. Department of Otolaryngology-Head and Neck Surgery, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. 2. Department of Otolaryngology-Head and Neck Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Banpo-daero 222, Seocho-gu, Seoul, 06591, Republic of Korea. 3. ROKIT Healthcare, Inc., Seoul, Korea. 4. Department of Otolaryngology-Head and Neck Surgery, GNG hospital, Seoul, Korea. 5. Department of Otolaryngology-Head and Neck Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Banpo-daero 222, Seocho-gu, Seoul, 06591, Republic of Korea. kshent@catholic.ac.kr.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of an injectable lyophilized articular cartilage matrix (LACM) which is in the form of cartilage powder that may increase the convenience of use and become unaffected by donor site morbidity as a potential filler. METHODS: The safety test was conducted using 20 rabbits with an intravascular embolization model. Commonly used commercial hyaluronic acid (HA), acellular dermal matrix (ADM), polymethyl methacrylate (PMMA), and polylactic acid (PLA) products were selected for comparison of efficacy and adverse effect of LACM. The efficacy test was performed using 30 mice subcutaneous buttock-injection model. Gross assessments of the changes in size of injected materials and histological examinations were conducted. RESULTS: Regarding the safety test, in one rabbit in the HA group, complete blurring occurred in the left eye, and necrosis of the posterior auricular artery was observed in one rabbit in the ADM group. In the ADM, severe ecchymosis around the injection sites was observed, and the bruises lasted longer than in the other groups. The LACM exhibited faster bruise resolution. Comparing the changes in size between weeks 4 and 12 in the mouse model, no significant changes in size were observed in the LACM (p = 0.359), HA (p = 0.421), and ADM (p = 0.097), but a significant change was observed in the PMMA (p = 0.001). In the histological examination, LACM exhibited well-demarcated margins with good biocompatibility. CONCLUSION: The LACM shows potential as a facial filler according to the in vivo safety and efficacy tests LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
OBJECTIVE: To evaluate the efficacy and safety of an injectable lyophilized articular cartilage matrix (LACM) which is in the form of cartilage powder that may increase the convenience of use and become unaffected by donor site morbidity as a potential filler. METHODS: The safety test was conducted using 20 rabbits with an intravascular embolization model. Commonly used commercial hyaluronic acid (HA), acellular dermal matrix (ADM), polymethyl methacrylate (PMMA), and polylactic acid (PLA) products were selected for comparison of efficacy and adverse effect of LACM. The efficacy test was performed using 30 mice subcutaneous buttock-injection model. Gross assessments of the changes in size of injected materials and histological examinations were conducted. RESULTS: Regarding the safety test, in one rabbit in the HA group, complete blurring occurred in the left eye, and necrosis of the posterior auricular artery was observed in one rabbit in the ADM group. In the ADM, severe ecchymosis around the injection sites was observed, and the bruises lasted longer than in the other groups. The LACM exhibited faster bruise resolution. Comparing the changes in size between weeks 4 and 12 in the mouse model, no significant changes in size were observed in the LACM (p = 0.359), HA (p = 0.421), and ADM (p = 0.097), but a significant change was observed in the PMMA (p = 0.001). In the histological examination, LACM exhibited well-demarcated margins with good biocompatibility. CONCLUSION: The LACM shows potential as a facial filler according to the in vivo safety and efficacy tests LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.