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F2211-04 생체조직공학적 의료제품(TEMPs)에 대한 표준 분류
소정원 ( Jung Won So ),김순희 ( Soon Hee Kim ),백미옥 ( Mi Ock Baek ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),유규하 ( Gyu Ha Ryu ),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ),강길선 ( Gil Son Khang ) 한국조직공학과 재생의학회 2008 조직공학과 재생의학 Vol.5 No.1
Tissue engineered medical products (TEMPs) are those protocols and products developed for use in the human body as biological substitutes to restore, maintain, or improve tissue function. So TEMPs may achieve a therapeutic potential from cells, biomolecules, scaffolds, and other materials, and processed tissue and derivatives used in various combinations or alone. Since interactions may occur among the components used in TEMPs, new standard descriptions, test methods, and practices are needed to aid the evaluation of these interactions. Therefore this technical report the aspects of tissue engineered medical that will be developed as standards.
ASTM F2027 조직공학적 의료용제품(TEMPs)을 위한 기질의 특성결정 및 테스트를 위한 표준 지침서
백미옥 ( Mi Ock Baek ),소정원 ( Jung Won So ),김순희 ( Soon Hee Kim ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),김문석 ( Moon Suk Kim ),유규하 ( Gyu Ha Ryu2 ),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ),강길선 ( Gilson Khang 한국조직공학·재생의학회 2007 조직공학과 재생의학 Vol.4 No.4
Tissue engineering medical products are those protocols and products developed for use in the human body as biological substitutes to restore, maintain, or improve tissue function. The purpose of this standard is to locate relevant existing guideline and test methods and to provide guidance for interim use of materials for which a standard does not exist. The standard may be use as guideline in tissue engineered research.
ASTM F813-07 의료용디바이스를 위한 생체재료의 직접촉 세포배양측정에 대한 표준지침서
김순희 ( Soon Hee Kim ),백미옥 ( Mi Ock Baek ),소정원 ( Jung Won So ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),김문석 ( Moon Suk Kim ),유규하 ( Gyu Ha Ryu2,),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ),강길선 ( Gilson Khang 한국조직공학·재생의학회 2007 조직공학과 재생의학 Vol.4 No.4
We provided standard practice for direct contact cell culture evaluation of materials for medical devices in this report. This practice introduced a reference method of direct contact cell culture testing. This method of direct contact cell culture may be used in the construction of medical materials and devices for test the cytotoxic potential of materials. Researcher for medical devices could use this practice to compare other cytotoxicity tests or directly to evaluate materials. Cell or materials could be sometimes modified depending on use in offered extend of this practice.
PLGA 지지체에 함유된 DBP 함량이 줄기세포의 골분화에 끼치는 영향에 대한 in vitro 테스트
백미옥 ( Mi Ock Baek ),김순희 ( Soon Hee Kim ),소정원 ( Jung Won So ),임지예 ( Ji Ye Lim ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),유규하 ( Gyu Ha Ryu ),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ),강길선 ( Gil Son Khang ) 한국조직공학과 재생의학회 2008 조직공학과 재생의학 Vol.5 No.1
Demineralized bone particles(DBP) exhibit osteoinductive properties and are very useful for bone formation and other orthopeadic applications. In this study, we investigated the osteogenic capabilities of rat bone marrow stromal cells(rBMSCs) in PLGA scaffold impregnated with various DBP contents. DBP-loaded PLGA scaffold (10, 20, 40, 80 % w/w) were prepared by solvent casting/salt leaching method. rBMSCs were seeded in PLGA and DBP/PLGA scaffolds, and then cellular viability and proliferation were assayed by water-soluble tetrazolium salt(WST-8) assay. Osteoblast differentiation of cells were analyzed by alkaline phosphatase(ALP) activity. Finally, reverse transcript polymerase chain reaction(RT-PCR) was assessed to measure mRNA expression of the genes (ALP, osteocalcine and type I collagen) of osteogenic marker in rBMSCs depending on various content of DBP. These results could demonstrated that presence of DBP in PLGA might play important roles in osteoblast differentiation of rBMSCs.
PLGA 담체의 제조방법에 따른 골수간엽줄기세포의 골분화 유도
소정원 ( Jeong Won So ),김순희 ( Soon Hee Kim ),백미옥 ( Mi Ock Baek ),임지예 ( Ji Ye Lim ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),유규하 ( Gyu Ha Ryu ),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ),강길선 ( Gilson Khang ) 한국조직공학·재생의학회 2008 조직공학과 재생의학 Vol.5 No.1
A key component in tissue engineering for bone regeneration is the scaffold that serves as a template for cell interaction and the formation of bone-extracellular matrix to provide structural support to the newly formed tissue. In this study, poly(L-Lactide-co-glicolide)(PLGA) scaffolds were prepared by solvent casting/salt-leaching, ice particle-leaching and gas-forming/salt-leaching. Cellular viability and proliferation were assayed by 3-(4,5-dimethylthiazole- 2-yl)-2,5-diphenyltetrazolium-bromide(MTT) test. Osteogenic differential cells were analyzed by ALP activity. Through RT-PCR analysis, we observed ALP and osteocalcin m RNA expression. Scaffold with BMSCs were implanted into the back of athymic nude mouse to observe in vivo behavior. Thin section were cut from paraffin embedded tissues and histological sections were stained by trichrome, immunohistochemical, von kossa staining. The cell proliferation and ALP activity of BMSCs in the scafoolds was the highest in the scaffolds using solvent casting/salt-leaching method. In RT-PCR results, in the all type of scaffolds observed specific gene expression of ALP, osteocalcin. By histological staining, we could observed collagen and calcification region in scaffolds by solvent casting/salt leaching method. Thus Solvent casting/salt-leaching method provided highly porous structure with good interconnections between each pores, which can support the surface of cell proliferation, differentiation. This result indicates that solvent casting/salt-leaching is useful for osteogenesis of BMSCs.
천연재료가 함유된 조직공학용 지지체에 대한 세포독성 분석법의 비교
백미옥 ( Mi Ock Baek ),김순희 ( Soon Hee Kim ),소정원 ( Jung Won So ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),김문석 ( Moon Suk Kim ),유규하 ( Gyu Ha Ryu ),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ),강길선 ( Gilson Khang 한국조직공학·재생의학회 2007 조직공학과 재생의학 Vol.4 No.4
Cytotoxicity measurements on materials are extremely important in tissue engineering field. The objective of this study is to measure and compare the cytotoxicity of scaffold for tissue engineered using 3-(4,5-dimethylthiazol- 2-yl)-2,5-diphenyl-tetrazolium bromide(MTT), 2-(methoxy-4-nitrophenyl)-3-(4-nitrophenyl)-5-(2-4- disulfophenyl)-H-tetrazolium(WST-8) and Alamar Blue cytotoxicity assay on cytotoxixity of scaffold for tissue engineering. In order to evaluate the sensitivity of rat bone marrow stromal cell(rBMSC) for cytotoxicity assays, a series of two-fold dilution of rBMSC were plated in 96-wells. rBMSC suspension was seeded on poly(lactide-coglycolide) (PLGA) scaffold and then cytotoxicity was measured in vitro by MTT, WST-8 and alamar blue assay. The MTT assay was more sensitive than WST-8, alamarblue assay for rBMSC. rBMSC suspension seeded on various content of demineralized bon particle(DBP) impregnated PLGA scaffold was measured to confirm on affect to natural material by MTT assay. In the MTT assay results, optical density was influenced by content of DBP. Finally, cytotoxicity of DBP/PLGA scaffold was assayed using modified method of ASTM F813-07. We confirmed that cell viability was significantly high in PLGA scaffold including DBP of 20 and 40% compared to other scaffolds. This report may be useful as guideline in tissue engineered scaffolds.
PLGA미립구의 크기에 따른 인간디스크세포의 증식 및 표현형 분석
소정원 ( Jeong Won So ),김순희 ( Soon Hee Kim ),백미옥 ( Mi Ock Baek ),임지예 ( Ji Ye Lim ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),김문석 ( Moon Suk Kim ),유규하 ( Gyu Ha Ryu ),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ) 한국조직공학·재생의학회 2007 조직공학과 재생의학 Vol.4 No.4
The PLGA microspheres can create an environment conductive to promising candidate as an injectable system for tissue engineered intervertebral disc(IVD). The final goal of this study was to investigate the condition of PLGA microspheres as microcarriers for IVD cells. We prepared PLGA microspheres using oil-in-water(O/W) solvent evaporation method and investigated the size variation of the microspheres(180~425 μm). Human disc cells were used in a prospective study of attachment, proliferation, and gene expression within various size of PLGA microspheres. Mophology of cell attached on the microspheres was studied using scanning electron microscopy (SEM). Cellular behavior in response to various size of PLGA microspheres was analyzed using MTT assay and reverse transcriptase - polymerase chain reaction(RT-PCR). SEM showed that cells could be bridge between microspheres with elongated shapes. MTT assay revealed that the cells could be attach, proliferate and spread on PLGA microspheres, in particular on the ones having size below 250 μm. In RT-PCR results, we observed strongly specific gene expression of type collagen at more 250 μm microsphere. In conclusion, this result will be used to injectable system for disc regeneration.
이해광,조양하,유규하,박해대,이창형,정호년,노혜원,정광훈,백동헌,장우익,김정구,이해빈 식품의약품안전청 2000 식품의약품안전청 연보 Vol.4 No.-
과학문명의 발전과 더불어 의료기기의 발전 추세는 한 가지 주요 기능 외에 부가적 기능을 겸비하는 다목적인 형태로 발전하고 있다. 이러한 다기능의료기기의 경우 부가기능이 주요 기능의 안전성에 위해를 가할 수 있으며, 또한 동작원리가 서로 다른 의료기기가 준합되어 사용되는 경우에는 전기적인 결합에 의한 간섭 등에 의하여 전기적인 위해의 요소가 증가할 수 있다. 파라서 본 연구에서는 대표적인 다기능 의료기기인 의료용 마취기를 중심으로, 제조사별 제품의 특성과 국제규격과의 조화를 고려하여 안전성 평가를 위한 기술규격을 개발하고자 한다. 또한 개발 확림된 의료용 마취71의 개별기준규격을 고시화하여, 페품의 안전성확보에 관한 기준규격으로의 유웅한 정보제공과 아울러 국제규격과 조화를 이룬 국내 제품의 개발 가능성을 극대화할 것으로 기대된다. The medical devi Purpose Ivhich includes additionalfunctions maf exert a harmful ices in these modern days have a current trend of multi-funci4ions other than major function. However,these additionalnfluence upon a major function such as potential risk of anaccordance with international standards, one of major multi-pumose rrom In)'estlgation ofvarious sl;andards on anaesthetic apparatus toThis standard directilye will be useful information to evaluatdomestic apparatus inharmony with international standards.
이해광,유규하,조양하,노혜원,박해대,이창형,정호년,양원선,김정구 식품의약품안전청 2001 식품의약품안전청 연보 Vol.5 No.-
조직긍학은 의학 연구 분야에서 활발한 성장을 보이핀 있늘 분야로 떠오르고 있다. 이러한 조직공f·? 제푿들 대다수는 자연적이거나 생체재료와 조합된 니포구성 성력의 이용에 의존하고 있다. 하지만 쵤근 들어 인공피부, 인긍연골 등 조직긍학 계품이 급슥히 상품화되어 출시될 단계에 있으나 이fl 퍼한 안전성과 유효성 평가피준은 아직 정린되지 못하초 있는 상채이다. 이에 본 연구에서는 믿을만한 의학적 산둘로서 자리 매깅 할 인공연골을-비릇한 조픽공학 재품을 사람에 적용함에 있어 이에 대:한 안전 성쏙 성능 평가를 위한 일반적인 접근을 시도곯였다. 쪼직공학 재품의 쵱가기법과 관련된 제품의 개발 과정베서 반드시 고려리어야 할 분야에 대하여 기쑨하있다. 이에 대한 사항은 다음과 같아 요약될 수 있다 : 1) 세포 및 조직의 유래 ?) 세포 딪 조직의 특서 3; 싱페재료 f,1험 4) 품질보증 5) 픔질관리 6) 비인상 딪 7) 꼴상 펼가가 이엑 해당된다. 로글 코픽공착 제픔 가운데 세포의 유래에 차하여 콩속꼭친 분야왁 독린적인 분야호 영역을 분리하였다. 첫 1,4Fil 길우는 T·11룸의 작용기작이 진체의 극뚜건 부위엑서 구즈쓱 기논의 수복이나 재건을 목적으로 사욧쓴:=7 겄이. 투 껀째 경우는 711품의 작응기각이 진신적으로꺼 껑리학적이나 약리학적으로 활성들 나니내글- 게붐이다. 일반적으초 조직공학 제품의 안진겊곽 성늘 편가를 워한 기법의 개발은 장대적으로 오랜 기간 동안 찬자에게 이식되는 제품에 초점이 딱추어꼭 것이며, 본쳔케서는 제 1단계 사업으로꺼 현Rf 상품화 단끼에 있는 인공연골을 중심으로 안전성쓱 껑능에 패글 기적적인 가이드라인을 )If시하핀자 곡다. 이는 관련 재품의 개발에 도음이 될 것이라 믿는다. Tissue Engineering is a very promising field in biomedical research and development. Guidance of tissue engineered medical devices(TEMDs) is very important for the patients' safety and national welfare. Most of TEMDs consist of natural and/or biomedical polymers and polymer- cell/tissue component mixture. Some TEMDs like artificial skin and cartilage are in the stage of commercialization, however, the evaluation standards and testing methods are not prepared yet. In this study, we have developed a guidance for the function, biocompatibility and safety tests of tissue-engineered cartilage. The guidance contains the essential checking ponits in the development process of TEMDs, which are as follow ; 1) cell or tissue origin 2) cell or tissue characteristics 3) biomaterial test 4) quality assurance 5) quality control 6) non-clinical evaluation 7) clinical evaluation. TEMDs were divided into two categories according to the cell origin. The first category contains the devices used for repair and reconstruction of structural function of impaired tissues. The other category contains the systemic devices with physiological and pharmacological activity. Generally, the guideline for function and safety of TEMDs would be focused on the long-term implants. We believe that adoption of thes guidance of tissue-engineered cartilage sould lead to the products consistent in quality and performance as well as safety.