제대혈 관리 및 연구에 관한 법률의 검토

이정현(Lee-Jeong Hyun) 충북대학교 법학연구소 2010 과학기술과 법 Vol.1 No.1

Umbilical cord blood is blood that is separated from the umbilical cord and placenta connected to a mother's body when the new born is detached from the mother‘s body at childbirth. Umbilical cord blood contains hematopoietic progenitor cells and stem cells. In the past, umbilical cord blood was physiologically inevitably separated from a human body and discarded with the umbilical cord and placenta and it was not a matter of concern. However, as biomedical technologies have been developed, it has become possible to freeze and keep umbilical cord blood and then defrost it to use it for patients' treatment. In Korea, since Catholic Hematopoietic Stem Cell Bank was instituted in 1996, umbilical cord blood banks have been established and operated mainly by university-affiliated hospitals including Samsung Medical Center in 1997, and Severance Hospital in 1998, and these days many organizations are also operating umbilical cord blood banks as a private corporation. As such banks were not supported by systems, the Ministry of Health and Welfare set umbilical cord blood bank practice standards in August of 2005. The standards aimed at ensuring an adequate level of quality and safety of human umbilical cord blood and contributing to the improvement of national health through standards for the management of human umbilical cord blood. Nonetheless, the standards were not legally enforceable, and thus it was required to secure a proper level of safety of human umbilical cord blood and to introduce laws regarding the management of umbilical cord blood including the collection, examination, safekeeping and supply of umbilical cord blood. The Umbilical Cord Blood Management and Research Act was established on March 17, 2010 and the law will become effective from July 1, 2011. On the below, the enactment process and main details of the Umbilical Cord Blood Management and Research Act will be addressed and the problems underlying in the law examined.

제대혈 관리 및 연구에 관한 법제와 개선방안

정연덕(Yeun Dek Chung) 중앙법학회 2010 中央法學 Vol.12 No.4

The purpose of this study is to develop legal standards in the field of management of umbilical cord blood. Umbilical cord blood consist of hemopoietic progenitor cell and stem cell. Recently doctors and scientist discovers many usage of cord blood. Cord Blood Act deals with cord blood transplantation, private cord blood bank and public cord blood bank. KONOS (Korean Network for Organ Sharing) is the central resource for government-funded technical, and medical related cord blood information. Private cord blood banks and public cord blood bank have invested lots of resource in gaining cord blood and related information. However, outcome of these information does not spread to patient. Thus Cord Blood Act not only regulate but also promote development of this Cord blood industry. After this enactment, the public will have benefit in cancer therapy. This paper aims to suggest a standard to deal with balance of Private Cord Blood Bank and Public Cord Blood Bank. It also deal with right of patient in using the information provide from KONOS. The public would be served by having ready access with cord blood information. Finally, it will address the need to consider issues for regulation of Cord Blood Business and distribution of information to develop a legal framework to deal with this problem.

Umbilical Cord Blood Transplantation

Ahn, Hyo Seop,Shin, Hee Young The Korean Association of Immunobiologists 2003 Immune Network Vol.3 No.2

The number of umbilical cord blood transplantation is increasing worldwide as it has expanded the ability of the transplantaion community to meet the growing needs of their patients. Clinical data over the last decade show promising results in transplantation using both related as well as unrelated cord bloods. Cord blood banks are essential for the clinical use for transplantation and are now established around the world with the major efforts to standardize banking in collection, processing and distribution of cord blood for providing the highest quality stem cells for the patients. In Korea, Medipost, Histostem and some regional cord blood banks were established some years ago and collected thousands of cord blood for public but it had some limitations and was not expanded as the cord blood transplantation was not covered by medical insurance. Recently with the change in the policy of medical insurance to cover the cord blood transplantation, several venture companies are showing great interests in cord blood banking and trying to establish private cord blood banks in Korea. This review article discusses the current status of cord blood transplantaion and also the clincial use of stem cells from cord blood.

제대혈은행 설립을 위한 제대혈의 적혈구 분리 방 법에 관한 연구

성기웅,강형진,이준아,한효정,최형수,박현진,유은선,김석현,유경하 大韓血液學會 1996 大韓血液學會誌 Vol.31 No.3

제대혈 조혈모세포 은행 설립을 위한 제대혈 분리방법의 표준화에 관한 연구

이영호,김흥식,이건수,국훈,황태주,박경덕,조빈,김학기,성기웅,신희영,안효섭,최용묵 大韓血液學會 1999 大韓血液學會誌 Vol.34 No.2

부산 지역 임산부의 모체혈, 제대혈, 모유에서 PFOA, PFOS의 농도

서춘희,이채관,김건형,손병철,이종태,Suh, Chun-Hui,Lee, Chae-Kwan,Kim, Kun-Hyung,Son, Byung-Chul,Lee, Jong-Tae 한국환경보건학회 2012 한국환경보건학회지 Vol.38 No.1

Objectives: Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) are man-made, persistent global pollutants widely diffused throughout the environment. They have been even found in the cord blood and breast milk of humans. Furthermore evidence of developmental toxicity in animals exists. To assess the distribution of maternal and fetal exposure to PFOS and PFOA, we analyzed paired maternal blood, cord blood and breast milk samples. Methods: Maternal blood, cord blood and breast milk were collected from 150 volunteers from the general population (aged 20-40, mean $30.5{\pm}2.9$) of the city of Busan in 2009-2010. The samples were extracted using the weak anion exchange and solid-phase extraction methods and quantified by high-performance liquid chromatograph (HPLC, Agilent 1200 Series) coupled with an Triple Quad LC-MS/MS system (Agilent 6410). Results: Median PFOA and PFOS concentrations in maternal blood were 2.18 and 3.32 ng/ml, in cord blood were 0.83 and 0.58 ng/ml, and in breast milk were 0.13 and 0.11 ng/ml, respectively. PFOS and PFOA concentrations were significantly correlated among matrices (Spearson's ${\rho}=0.226$, p = 0.05 for maternal blood; ${\rho}=0.736$, p < 0.01 for cord blood; ${\rho}=0.493$ p < 0.01 for breast milk). The ratio of cord blood/maternal blood was 0.39 for PFOA and 0.19 for PFOS. The ratio of breast milk/maternal blood was 0.07 for PFOA and 0.06 for PFOS. Conclusions: Our findings suggest that PFOA and PFOS exposure through the placenta was more prominent than through breast milk among Korean neonates born in Busan. The transfer efficiency of maternal blood to breast milk was similar between PFOA and PFOS, but that of maternal blood to cord blood was higher in PFOA than PFOS.

COVID-19 판데믹이 기증제대혈은행에 미치는 영향

고리영,김정아,박수지,심재룡,곽민선,김경희 대한수혈학회 2022 大韓輸血學會誌 Vol.33 No.2

The COVID-19 pandemic has had a major impact worldwide, making it difficult to transplant unrelated hematopoietic stem cells. On the other hand, cord blood transplantations in Korea increased during the pandemic. In 2021, the release of 110 cord blood units and 83 cord blood transplantations were performed. Cord blood transplants have increased by 35% compared to the pre-pandemic period (average of 58 cases over four years vs. 78 cases over two years). This phenomenon is not only occurring in Korea. In France, cord blood transplantation in 2020 increased by 19% compared to the previous year. The cord blood is the blood in the umbilical cord and placenta that would be discarded during childbirth but can be used as a useful source of hematopoietic stem cells in the COVID-19 pandemic. In addition, it is essential to collect and store high-quality cord blood continuously because of the high likelihood of developing various therapeutic agents using cord blood. (Korean J Blood Transfus 2022;33:114-117)

제대혈 채취 후 유로키나제의 첨가가 제대혈 적혈구 제거시 조혈모세포의 수득률에 미치는 영향

이영호,박현우,이영아,한훈,김경희,한진영 대한조혈모세포이식학회 2000 대한조혈모세포이식학회지 Vol.5 No.1

목적:제대혈 채취 후 24시간이 경과하여 적혈구를 제거하는 경우에 제대혈내의 응고계 및 섬유소 융해계의 변화로 인하여 clumping이나 미세혈전 등이 생겨 유핵세포나 CD34+ 세포의 수득률이 감소될 수 있다. 따라서 비록 항응고제가 처리된 제대혈이라 할지라도 제대혈 분리 전에 urokinase를 첨가하면 조혈모세포의 수득률을 높일 수 있을 것으로 생각된다. 그러나 현재까지 이에 대한 연구가 전혀 없는 상태이므로, 본 연구에서는 시간이 경과된 제대혈에 urokinase를 첨가하는 것이 효과가 있는지, 있다면 얼마의 용량이 적절한지 알아보기로 하였다. 방법:1) 채취한 후 48시간 경과된 제대혈에 대한 분석: 15례의 제대혈을 채취하여 채취 직후와 48시간 후에 10% pentastarch로 적혈구를 분리한 다음, 총유핵세포수와 CD34+ 세포수를 측정하여 수득률을 비교하였다. 48시간이 경과한 검체에 대하여 urokinase는 제대혈 분리 30분 전에 첨가하였으며, urokinase를 첨가하지 않은 군과 urokinase 5,000 IU/mL, 10,000 IU/mL, 50,000 IU/mL을 첨가한 네군으로 나누어 각각의 수득률을 비교 분석하였다. 2) 채취한 후 24시간이내의 제대혈에 대한 분석: 12례의 제대혈을 채취한 직후에 적혈구를 분리하여 총유핵세포수와 CD34+ 세포수, CFU-GM 집락수를 측정하였다. 동일한 검체를 6시간, 12시간, 24시간 동안 실온에 방치한 후 상기 실험 결과 가장 효과적인 용량의 urokinase를 첨가한 군과 첨가하지 않은 군으로 나누어 각각 적혈구를 분리한 다음, 총유핵세포수와 CD34+ 세포수, CFU-GM 집락수를 측정 비교하였다. 결과:1) 제대혈 채취 48시간 후에 urokinase를 첨가하지 않은 경우와 urokinase 5,000 IU/mL를 첨가한 경우 총유핵세포수의 차이가 없었지만, urokinase 10,000 IU/mL, 50,000 IU/mL를 첨가한 경우에는 urokinase를 첨가하지 않은 경우에 비하여 총유핵세포수의 의미있는 증가를 보였다(P=0.0024, P=0.0009). 2) 제대혈 채취 48시간 후에 urokinase 5,000 IU/mL이나 50,000 IU/mL를 첨가한 경우에는 urokinase를 첨가하지 않은 경우에 비하여 CD34+ 세포수의 차이가 없었지만, urokinase 10,000 IU/mL를 첨가한 경우에는 urokinase를 첨가하지 않은 경우에 비하여 CD34+ 세포수의 의미있는 증가를 보였다(P=0.0402). 3) Urokinase 10,000 IU/mL를 첨가하였던 군이나 첨가하지 않았던 군 모두에서 제대혈 채취 즉시 적혈구를 분리하였던 경우에 비하여 6시간, 12시간, 24시간이 경과할수록 총유핵세포수, CD34+ 세포수, CFU-GM 집락수가 약간씩 감소하였으나 시간경과에 따른 통계적 차이는 없었다. 또한 제대혈 채취 24시간 이내에는 각 시간대별로 urokinase 10,000 IU/mL 첨가 유무에 따른 총유핵세포수, CD34+ 세포수, CFU-GM 집락수의 통계적 차이를 나타내지 않았다. 결론:채혈한지 48시간 경과된 제대혈을 냉동 보관해야 하는 경우에는 urokinase 10,000 IU/mL를 첨가하고 30분 후에 적혈구를 분리하는 것이 유핵세포와 CD34+ 세포의 수득률을 높일 수 있는 방법이며, 24시간 이내에 적혈구를 분리하는 경우에는 urokinase를 첨가할 필요가 없을 것으로 생각된다. Background:We assessed whether the urokinase could increase the yield of progenitor cells during processing in elapsed, even anticoagulated, cord blood after collection, and also determined the optimal dosage of urokinase. Methods:Twenty-seven cord blood samples were collected with ACD-coated syringes from umbilical cord vein after full-term vaginal delivery, and red cells were depleted with 10% pentastarch. We assessed the effect and optimal dosage of urokinase by comparing total nucleated cell (TNC) counts and CD34+ cell counts between fresh and 48 hour-elapsed cord bloods. The urokinase was administered to the 48 hour-elapsed cord bloods 30 minutes before separation as the dose of 0 IU/mL, 5,000 IU/mL, 10,000 IU/mL and 50,000 IU/mL, respectively. Thereafter, by using the most effective dosage of urokinase, we also assessed the effect of urokinase in the 6, 12 and 24 hour-elapsed cord bloods. Results:The TNC counts after separation in 48 hour-elapsed cord bloods were significantly higher in 10,000 IU/mL and 50,000 IU/mL of urokinase treated samples than untreated and 5,000 IU/mL treated samples. The CD34+ cell counts were significantly higher in 10,000 IU/mL of urokinase treated samples than untreated and 5,000 or 50,000 IU/mL treated samples. In 6, 12 and 24 hour-elapsed cord bloods, however, there were no significant differences of TNC count, CD34+ cell count and CFU-GM count between 10,000 IU/mL of urokinase treated samples and untreated samples . Conclusion: The addition of 10,000 IU/mL of urokinase before separation of 48 hour-elapsed, even anticoagulated, cord bloods could increase the yield of progenitor cells. However, there are no advantage of urokinase for processing of cord bloods not elapsed 24 hours after collection.

우리나라와 일본의 조혈모세포이식 관련법의 비교검토

송영민(Song, Young-Min) 원광대학교 법학연구소 2021 圓光法學 Vol.37 No.3

조혈모세포는 채취 방식 및 장･단점에 차이가 있지만, 골수･말초혈･제대혈로부터 채취가 가능하다는 기본적인 공통점을 가지고 있다. 조혈모세포이식법과 같은 통합적인 법의 제정은 ① 현행 ｢장기이식법｣ 체계상의 문제점을 해결할 수 있다는 점, ② 골수이식, 제대혈이식, 말초혈이식 등 이들 이식만이 갖는 고유한 기능에 대한 보다 적극적인 연구 및 이용의 활성화가 가능하다는 점, ③ 이들 물질의 통합적 관리시스템의 구축이 가능하다는 점 등의 장점이 있다. 일본은 우리나라에 비해 비교적 입법적 해결이 늦었지만 제대혈이식 성적은 우수한 것으로 알려지고 있다. 이는 조혈모세포이식법상의 골수, 말초혈, 제대혈을 통합하는 조혈모세포이식 데이터 센터(The Japanese Data Center for Hematopoietic Cell Transplantation, JDCHCT)를 중심으로 이식받은 환자 및 기증자의 폭넓은 정보를 수집하고 분석한 결과라고 한다. 반면에 우리나라는 각각의 독립된 법체계로 인하여 골수, 말초혈, 제대혈을 통합하는 정보수집과 제공에 일정한 한계가 있음을 부인할 수 없다. 이러한 이유로 의료계 내부에서도 이들 특별법의 상위법인 조혈모세포법의 제정이 필요하다는 의견이 있다. 더 나아가 최근에는 장기 등 이식에 관한 법률, 인체조직안전 및 관리 등에 관한 법률의 통합에 의해 자원의 관리와 배분의 효율성을 높이자는 움직임도 있다. 의생명과학의 발달로 인하여 인체의 다양한 부분을 치료나 연구의 목적으로 사용할 가능성은 점점 더 증가하고 있다. 입법 단계에서는 현재 발생한 문제를 해결하기 위한 단편적 측면이 강조되는 경우가 있다. 그러나 또 다른 한편으로는 장래에 발생가능한 법률문제 해결을 위한 법의 예측기능을 강조해야 하는 경우도 있다. 의생명과학기술의 비약적인 발전은 사전에 예측할 수 없는 법률문제를 발생시킬 수도 있지만 적어도 예측가능한 부분에 대해서는 사전예방적 차원에서 입법작업시에 검토되어야 할 것이다. 그렇다면 이번 기회에 골수, 말초혈, 제대혈을 통합하는 이른바 조혈모세포이식법을 제정하여 조혈모세포의 통합관리와 배분을 기하고 의료기술의 발전에 따른 법의 탄력적인 집행이 가능하게 할 필요가 있다. Although there are different collection methods, advantages and disadvantages in hematopoietic stem cell, it has basic common point to be able to collect from bone marrow, peripheral blood and umbilical cord blood. There are several advantages through integrative legislation like hematopoietic stem cell act, they are as follows. ① it can solve the problem about current ｢Internal Organ Transplant Act｣, ② it can activate more active research and use on unique function of bone marrow transplantation, umbilical cord blood transplantation and peripheral blood transplantation, ③ it can build integrative management system. Japan was late to solve legislatively comparing Korea, however the results of umbilical cord blood transplantation was excellent. This is the result of collecting and analysing wide-ranging information about donee and donor focusing on JDCHCT(the Japanese data center for hematopoietic cell transplantation) integrating bone marrow, peripheral blood, umbilical cord blood. On the other hand, Korea has certain limit to collect and provide the information integrating bone marrow, peripheral blood, umbilical cord blood due to each independent legal system. Thus, there is an opinion to legislate hematopoietic stem cell act, a higher act of this special act, in the medical world. Furthermore, there is a move to enhance efficiency of management and distribution of resource through integrating internal organs, etc. transplant act, and safety, management, etc. of human tissue act. The possibility to use various parts of human body for research and remedy is more and more increasing by development of biomedical science. Fragmentary side would be highlighted to solve current problems in legislative steps, but on the other hand, legal predictive function should be highlighted to solve possible legal problems in the future. Rapid development of biomedical science would generate unpredictable legal problems, but, at least, predictable parts should be examined as a preventive dimension in the legislative work. Therefore, it is necessary to enforce flexible law through integrative management and distribution of hematopoietic stem cell and development of medical technology by legislating so-called hematopoietic stem cell transplantation act that integrates bone marrow, peripheral blood, umbilical cord blood.

저장 제대혈액의 혈장 유리혈색소치, Adenosine Triphosphate와 2,3-Diphosphoglycerate의 변화

이정이,조희순,김동욱,이채훈,김경동,김정숙 대한임상병리학회 1997 대한임상병리학회지 Vol.17 No.2