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The Clinical Investigation Of Stem Cell And Its Management Strategies Study In Our Country

Posted on:2017-08-29Degree:MasterType:Thesis
Country:ChinaCandidate:T J JiangFull Text:PDF
GTID:2334330485481374Subject:Social Medicine and Health Management
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Clinical study of stem cells in medical research is one of the most popular and most cutting-edge medical projects in recent years,it have made significant progress in the treatment of endocrine disorders,cardiovascular disease and cancer and other diseases,the stem cell therapy field already has a broad market.The attractive prospect prompted many hospitals and enterprises to increase investment,manyscientists and clinicians around the world have also attached great importance to the clinical applications of stem cell research.Currently there are nine kinds of stem cell products around the world,international industrial development of stem cells showed accelerating trend.Although China also has made breakthrough progress in the stem cell field,but stem cell technology is still in clinical studies,we have not yet entered clinical applications,especially compared with Japan and South Korea and other major scientific and technological country.In order to promote the stem cells industry developed healthy,many countries formulated relevant management policies.In the 1990 s,China began to use stem cell technology in clinical research and treatment;China has issued a series of management policies in stemcell technologyand ethical aspects,but has not yet established a comprehensiveregulatory regime,management policies did not raise to thelegal level.At the same time,doctors are not familiar to the policy,and most of them are not satisfied with the management effect.In this paper,we investigated the stem cell clinical research progress in China,as well as Medical personnel policy awareness,satisfaction surveys,finding the problems,making recommendations,providing a reference for stem cell clinical research administrationpolicy.1.ObjectiveThis study focuses on current progress of stem cellclinical research,as well as effect.Learning stem cells clinicians' cognition and satisfaction of current stem cell management policy,try to discover the characteristics,in order to further the development of stem cell clinical research and improve the regulations to provide advice,prompting the basic research transfer to the clinical application,accelerating stem cell clinical application of the results output.2.Materials and MethodsResearch objects come from Shenyang Army General Hospital of Military Region,463?202 Hospital of Shenyang Military Region,Dalian 214 hospitals,Dalian 210 hospitals,Dalian Central Hospital,Beijing Air Force General Hospital,Beijing 263 Hospital,Guangzhou Military Region General Hospital,Guangzhou Zhujiang Hospital,Guangdong Province people's hospital,Chengdu Military General Hospital,Nanjing Military Region General Hospital,Suzhou Provincial People's Hospital,Shanghai Changhai Hospital,Shanghai 85 Hospital,Shanghai Eastern Hepatobiliary Hospital,Shanghai Changzheng Hospital,Zhongshan Hospital of Hubei Province,East China Henan liver disease Hospital and Lanzhou Military Region General Hospital,a total of 21 units(East China Henan liver disease Hospital is constructed according to the national three level of first-class hospital standard),45 clinical studies conducted stem cells departmentsand 37 project teams,290 doctors.The study uses self-designed questionnaire,investigated the source,approval authority,approval time,Indications,to to conduct a comprehensive analysis.At the same time,this study carries out the construction department,personnel structure,etc.In addition,the stemcells in clinical research physician for clinicalmanagement policy awareness,management effectivenesssatisfaction surveys stem cells are included.This paper adopts descriptive analysis,?2 text,and logistic multivariate analysis.We use software SPSS13.0 to entry and analysis data,P <0.05 was statistically significant.3.Results(1)The departments which conduct clinical trials of stem cell includedhematology,neurology,gastroenterology,endocrinology and other departments,the most mature is hematology.The cells are mostly allogeneic stem cell,mainly obtained from peripheral blood,umbilical cord blood and bone marrow.Most clinical Stem cell therapy is indicated for two or more,but some indicate six.More than half of patients adverse reactions in clinical stem cell therapy,most symptoms are headache,fever and allergy.Compared with the general therapy,64.9% of the efficacy of stem cell therapy is superior to ordinary therapy program,the remaining 35.1% of the therapeutic effect is almost the same with ordinary therapy,and there is no significant difference.In clinical trials,the majority of hospitals(73%)charged to the patient,most of stem cell therapies cost 10 million,some of them cost more than one million.(2)The personnel structure of clinical research department of stem cells is not reasonable,some departments lack of young doctors,senior level doctors.82.2% of the department had not imported from abroad stem cell clinical research professionals,some department lack of international meeting experience,and 33.3% of the department had never make speech in the international meeting.In the part of cooperation,33.3% o of department has never been cooperated with the basic research sector,66.7% of the department has never been cooperated with the stem cell enterprise,and the cooperation with the basic research sector is a major factor in stem cell research used in clinical treatment of confidence.(3)The clinical doctors lack of professional and technical training,hospitals and departments should strengthen the stem cell clinical research physician training policy.9.0% of the doctors totally does not care about our management policy of stem cells,54.1% of physicians do not know the country's new 2015 introduction.Training policies is the factor to doctors whether understand the current management policies.The vast majority of doctors think the current clinical management of stem cell policy is imperfect,only 45.3% of doctors believe that the current regulatorypromote the development of clinical applications of stem cells.21% of the doctors expressed dissatisfaction with the current management effectiveness;resources(people,money,equipment)are the main factors that influenced satisfaction.Most doctors believe that they need active policies to promote the development of stem cell technology in clinical applications.4.Promblems and RecommendationsClinical study of stem cells developed rapidly in recent years,our country has also introduced some management policy,but there is still a gap among developed countries.At present,the main problems in the clinical research of stem cells in China are as followed: Stem cell clinical research management specification still need to be improved,patients are charged and some operating procedures do not comply with the provisions of the state administration,the resource allocation and talent structure of the stem cell clinical research department are not good enough to support the development of the stem cell cilinicl research,the cooperation between clinical research and basic research is not close enough,the doctor of stem cell clinicl research need to improve their technical ablity and policy cognition.In order to promote clinical research and development of stem cells,we shouldenhance stem cell clinical department building,improve resource allocation,increasing capital investment,and encourage the cooperation with basic researchdepartments.At the same time,we should strengthenpersonnel training,build reasonable echelon personnel.Hospitals should provide adequate resources to support stem cell therapy department develop,providing them more opportunities to further their study,and carry out clinical research training seminars regularly.In order to promoteclinical research of stem cells development healthy,we suggest build a information platform,give stem cell clinical researchers and managers a platform to communicate information.At the same time,we should enhance supervision,making stem cells guidance document management level rose to laws and regulations.In the meanwhile,we should guide patient making reasonable choice,promote stem cell treatment rationally.Only in this way can we promote our stem cell clinical research developssustainably and effectively.
Keywords/Search Tags:stem cells, clinical research, policy, talent echelon, regulatory regime
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