• 의료법학
• /
• 제22권4호
• /
• pp.159-184
• /
• 2021

첨단재생바이오법의 제정 의의는 본질적으로 '이식'이라는 의료행위인 재생의료를 약사법 규제에서 벗어나 의료기술적 접근으로 환자치료기회를 확대하는 데 있다. 그러나, 법이 시행된 지 1년여가 지난 상황에서 식약처가 승인하는 고위험연구는 1건도 승인되지 않고 있는 등 임상연구가 활성화되지 않고 있다. 그 이유는 환자치료기회 확대를 위한 법률 취지에도 불구하고 법률적 근거가 미흡함에도 임상연구 승인을 위한 자료요건을 의약품 개발과 연결하여 정하고 있어 많은 연구자들이 자료요건을 맞추기가 어려운 실정이다. 법 제정 이전 약사법 체계 내의 세포치료제 임상연구를 위한 제출자료는 품질 및 비임상시험 자료가 상당히 면제되었지만, 첨단재생바이오법이 시행되면서 임상연구 계획 승인신청 시 품질 및 비임상시험자료를 의약품에 준해 요구하고 있다. 이를 바로잡으려면 치료기회 확대를 위한 첨단재생의료 임상연구의 정체성을 고려할 때 의약품 개발과 연결하는 데는 제한점이 있음을 인식하고 첨단재생의료 임상연구의 정체성을 지키고, 한편으로 품목허가 시 임상연구 결과를 활용할 수 있도록 하면서 활용요건을 구체화하여 시장의 힘으로, 임상연구자의 자발적인 동기로 임상연구 승인을 위한 기본요건보다 필요한 자료를 스스로 준비할 수 있도록 해야 한다.

• Journal of Microbiology and Biotechnology
• /
• 제34권5호
• /
• pp.1003-1016
• /
• 2024

This study explores the potential of plant-based decellularization in regenerative medicine, a pivotal development in tissue engineering focusing on scaffold development, modification, and vascularization. Plant decellularization involves removing cellular components from plant structures, offering an eco-friendly and cost-effective alternative to traditional scaffold materials. The use of plant-derived polymers is critical, presenting both benefits and challenges, notably in mechanical properties. Integration of plant vascular networks represents a significant bioengineering breakthrough, aligning with natural design principles. The paper provides an in-depth analysis of development protocols, scaffold fabrication considerations, and illustrative case studies showcasing plant-based decellularization applications. This technique is transformative, offering sustainable scaffold design solutions with readily available plant materials capable of forming perfusable structures. Ongoing research aims to refine protocols, assess long-term implications, and adapt the process for clinical use, indicating a path toward widespread adoption. Plant-based decellularization holds promise for regenerative medicine, bridging biological sciences with engineering through eco-friendly approaches. Future perspectives include protocol optimization, understanding long-term impacts, clinical scalability, addressing mechanical limitations, fostering collaboration, exploring new research areas, and enhancing education. Collectively, these efforts envision a regenerative future where nature and scientific innovation converge to create sustainable solutions, offering hope for generations to come.

• The Journal of Advanced Prosthodontics
• /
• 제16권4호
• /
• pp.244-254
• /
• 2024

PURPOSE. This study aimed to evaluate the reliability and validity of a four-item questionnaire using a face rating scale to measure dental trait anxiety (DTA), dental trait fear (DTF), dental state anxiety (DSA), and dental state fear (DSF). MATERIALS AND METHODS. Participants were consecutively selected from patients undergoing scaling (S-group; n = 47) and implant placement (I-group; n = 25). The S-group completed the questionnaire both before initial and second scaling, whereas the I-group responded on the pre-surgery day (Pre-day), the day of implant placement (Imp-day), and the day of suture removal (Post-day). RESULTS. The reliability in the S-group was evaluated using the test-retest method, showing a weighted kappa value of DTA, 0.61; DTF, 0.46; DSA, 0.67; DSF, 0.52. Criterion-related validity, assessed using the State-Trait Anxiety Inventory's trait anxiety and state anxiety, revealed positive correlations between trait anxiety and DTA/DTF (DTA, ρ = 0.30; DTF, ρ = 0.27, ρ: correlation coefficient) and between state anxiety and all four items (DTA, ρ = 0.41; DTF, ρ = 0.32; DSA, ρ = 0.25; DSF, ρ = 0.25). Known-group validity was assessed using the initial data and Imp-day data from the S-group and I-group, respectively, revealing significantly higher DSA and DSF scores in the I-group than in the S-group. Responsiveness was gauged using I-group data, showing significantly lower DSA and DSF scores on post-day compared to other days. CONCLUSION. The newly developed questionnaire has acceptable reliability and validity for clinical use, suggesting its usefulness for research on dental anxiety and fear and for providing patient-specific dental care.

• Maxillofacial Plastic and Reconstructive Surgery
• /
• 제41권
• /
• pp.29.1-29.10
• /
• 2019

Background: Reduction in postoperative complications is of vital considerations in impacted third molar teeth surgery. The aim of this study was to compare postoperative complications of impacted third molar surgeries for bone removal using laser, piezoelectric equipment, and conventional rotary instruments. Methods: To address the research purpose, the investigator designed the prospective double-blind clinical trial study. The sample size was determined 20 (40 teeth) by sampling formula in any kind of operation. The data of patients were obtained in the different periods in terms of pain, trismus, swelling, ecchymosis, and patient's satisfaction and then analyzed using SPSS 20 software via paired t test and Wilcoxon and McNemar's tests. Results: The pain immediately after surgery and 2 days and 7 days after surgery was higher in the laser group. The swelling immediately after surgery was more in the laser group but not significant. The amount of mouth opening immediately after surgery and 2 days and 7 days after surgery was significantly lower in the laser group than in the piezosurgery group. The total duration of surgery and duration of osteotomy were significantly longer in the laser group. The patient's satisfaction from surgery with piezosurgery was more than that with laser, but this difference was not significant. Conclusion: Due to the rising demand for impacted wisdom tooth surgery, the present study suggests that hard tissue laser surgery and piezosurgery can clear the future of impacted molar surgery, and these approaches are more efficient in reducing postoperative complications compared to the conventional surgeries.

• 생명과학회지
• /
• 제30권8호
• /
• pp.672-679
• /
• 2020

원위 근병증은 원위 근육의 퇴행성 질환이며 임상적, 유전적으로 이질적인 그룹이다. 당원 축적병 9D (GSD9D)는 원위 근병증 중 하나이며, 근육의 포스포릴라아제키나아제(phosphorylase kinase) 결핍을 특징으로 하는 대사 근병증이다. GSD9D 환자는 운동 후 근육 약화, 근육 변성, 경련과 비정상적인 근육통 및 근육 경직이 발생될 수 있다. GSD9D는 글리코겐 대사의 주요 조절 효소 인 근육 포스포릴라아제키나아제의 알파 소단위를 암호화하는 PHKA1 유전자의 돌연변이로 유발된다. 이 연구에서 우리는 한국인 GSD9D 가족에 대해 PHKA1 유전자에서 c.3314T> C (p.I1105T) 돌연변이를 동정하였다. 이 돌연변이는 이전에 어떠한 돌연변이 데이터베이스에서도 보고되지 않았으며 500명의 건강한 대조군에서도 발견되지 않았다. 이 돌연변이 영역은 다양한 다른 종 내에서 잘 보존되었으며 in silico 분석에서 돌연변이가 병원성일 가능성이 있다고 예측했다. 현재까지 PHKA1 유전자에는 보고된 병원성 돌연변이가 7개뿐이며 한국에서는 보고된 사례가 없다. 따라서 이 연구는 한국 GSD9D 환자의 첫번째 사례이다. 또한 이 연구는 이전에 보고된 환자와 한국 환자의 임상 증상과 병리 상태를 비교하고 설명하고자 하였다. 아울러 우리는 본 연구가 GSD9D의 분자 진단에 유용하게 활용될 것으로 기대한다.