• The Korean Society of Law and Medicine
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• v.16 no.1
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• pp.191-219
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• 2015

The Japanese government has announced that it would invest 30 billion yen in iPS cell research for the next 10 year, and the Japan National Assembly has made an act that supports the iPS cell research. This study analyzes 1) the current trend and application field of stem cell research under Japan; 2) recent policy and regulation change in stem cell research and its application under Japan. This treatise reviews about "Act for Promoting Regenerative Medicine", "Act for Assuring Safety of Regenerative Medicine", and "the Revision of Pharmaceutical Act under Japan. This study may serve as the fundamental reference for the improvements of legal and institutional systems with regard to regulations on the stem cell research under Korea.

• The Science & Technology
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• s.507
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• pp.14-17
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• 2011

• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.159-184
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• 2021

The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.

• Ceramist
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• v.7 no.1
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• pp.41-46
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• 2004

우리나라에서 노령화가 급속히 진행됨에 따라 근골격계(뼈 및 관절부분)의 기능 장애는 개인의 삶의 질을 심각하게 저하시킬 뿐만 아니라 개인 및 국가 경제에도 큰 손실을 초래하고 있다. 현재 국내에서 사용되고 있는 근 골격계의 재생/재건/재활 관련 의료기기 대부분은 수입에 의존하고 있다. 고가의 수입제품의 사용은 심각한 경제적 손실 뿐 만 아니라 환자의 의료비 부담에 따른 양질의 의료혜택에도 지장을 주고 있다.(중략)

• The Science & Technology
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• s.507
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• pp.18-22
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• 2011

• Journal of the KSME
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• v.55 no.11
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• pp.40-45
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• 2015

의료용 장치, 인공장기에 사용하는 재료 중 인체 조직과 접촉하여 사용하는 재료를 생체재료라고 한다. 이 글에서는 생체재료 계면에서의 세포 반응 조절을 통해 조직의 재생과 치유를 돕기 위한 나노공정 기술을 소개하고자 한다.

• Health and Mission
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• s.6
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• pp.54-54
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• 2006

• Health and Mission
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• s.4
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• pp.17-19
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• 2005

줄기세포는 난치병에 걸렸을 때 장기의 기능을 담당할 수 있는 세포를 재생해 낼 수 있게 한다. 줄기세포는 근래에 "21세기판 불로초"로 불리며, 무한히 증식 될 수 있는 자기 재생능, 정상염색체 유지 및 다양한 세포로의 분화 등 놀라운 특성으로 난치병, 노인성 질환 치료를 위한 치료제로 활용 중이다.

• Health and Mission
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• s.4
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• pp.29-38
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• 2005

가장 경이로운 것은 치유와 회복의 근원으로서의 재생의 힘을 가진 성체줄기세포가 우리 몸 안에 있고, 주님께서는 그러한 기적을 우리에게 허용하셨다는 사실일 것이다.

• Journal of the Korean Crystal Growth and Crystal Technology
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• v.33 no.2
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• pp.71-77
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• 2023

Absorbable periodontal tissue regeneration barrier membranes (total 6; domestic 4; import 2) were comparatively analyzed. In the case of the xenograft barrier membrane, the collagen product had excellent tensile strength but low strain, and the porcine pericardial membrane had good mechanical properties, but its thickness was too thick to control. The synthetic PLLA membrane manufactured by the electrospinning had a relatively low water absorption capacity. However, the hybrid barrier membrane was able to control mechanical properties and biocompatibility through proper mixing of synthetic polymer and natural polymer. DA02 (PLLA/gelatin), a newly developed hybrid absorbable periodontal tissue regeneration membrane that is entirely dependent on imports, can be applied to an absorbable periodontal tissue regeneration barrier membrane due to suitable mechanical properties and biocompatibility.