• 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.

• Maxillofacial Plastic and Reconstructive Surgery
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• v.41
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• pp.29.1-29.10
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• 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.

• Journal of Life Science
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• v.30 no.8
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• pp.672-679
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• 2020

Distal myopathy is a clinically and genetically heterogeneous group of degenerative diseases of the distal muscle. Glycogen storage disease type IXD (GSD9D) is a metabolic distal myopathy characterized by muscle deficiency of phosphorylase kinase, a key regulatory enzyme in glycogen metabolism. Affected individuals may develop muscle weakness, degeneration, and cramps, as well as abnormal muscle pain and stiffness after exercise. It has been reported that mutations in the PHKA1 gene which encodes the alpha subunit of muscle phosphorylase kinase cause GSD9D. In this study, we examined a Korean GSD9D family with a c.3314T>C (p.I1105T) mutation in the PHKA1 gene. This mutation has not been previously reported in any mutation database nor was it found in 500 healthy controls. The mutation region is well conserved in various other species, and in silico analysis predicts that it is likely to be pathogenic. To date, only seven mutations in the PHKA1 gene have been documented, and this is the first report of Korean GSD9D patients. This study also describes and compares the clinical symptoms and pathological conditions of previously reported cases and these Korean patients. We believe that our findings will be useful for the molecular diagnosis of GSD9D.