Cells are transplanted and treated: Hold cells to prepare and close

Cells are transplanted and treated: Hold cells to prepare and close
Staff reporter Good special correspondent Huang XianBin TanCells - -Construct the foundation stone of the life entity. Draw the motive power of overcoming disease in the foundation stone of constructing the life entity, it has been the goal that the medical circle has sought assiduously all the time, one challenging the intersection of exploration and course at the same time, demand guarantee security of technology this put in the first place. Ministry of Public Health solicit opinion " whether cell transplant the standardard management of the treatment technology " ' Hereafter referred to as " norm ") ,Will guarantee technological security will be classified as the most important thing.Eliminate a batch of medical organizations not up to standard ofHaematological researcher of research institute, national project director of research center Dr. Han Zhongchao of cell products of Chinese Academy of Medical Sciences say, cell it transplants to be have normal function and active cell in the human histoorgan, " move and plant into " The patient is in the body, thus achieve and substitute or mend patient's damaged organ and treatment of the tissue. Hematopoietic stem cell transplant, treat blood disease kind of cell transplantation technology that you familiar with most. Transplant the hepatocyte, treat hepatopathy, pancreas cell to transplant, treat transplantation technology of cell such as diabetes, have made sure progress too in recent years.PLA man treat director, the infectious disease Professor Wang FuSheng, chief of research institute of PLA of research center and introduce 302 hospitals of living beings, cells can already play a certain role in treating important internal organs damaging, disease in the blood system, acute traumatism, disease of nervous system etc. while transplanting the treatment technology.According to the introduction of expert, several dozen medical organizations have already launched cells and transplanted the treatment technology at home at present, but mostly do things in his own way, lack unified technical standard and norm. The specific organization is driven by the economic benefits, get on horse hurriedly, it is difficult to guarantee therapeutic security and validity, have damaged the patient's interests.Han Zhongchao say as one new the intersection of disease and treatment means, cell transplant treat and have the characteristic of high-tech content. This norm has set up the line of minimum standard, will eliminate a batch of medical organizations not up to standard of, avoid causing medical risk and unnecessary expense expenditure to patient.Cells are prepared must accord with high-standardlyIn cells are transplanted and treated, the main weapon that doctors used is the cells with normal function activity, so, it is to determine cells and transplant the first step in quality that ripe cells prepare technology."Cells prepare the hardware condition with high-level need to guarantee. " Han Zhongchao introduces, at first, it is qualified to support the body to need choosing; In gather, get qualified support organization, organ of body, separate and make into cells and hang the liquid particular cells; It will should find whether there are enough cell numbers to carry on the quality testing of the cell products at the same time, whether cells keep enough activity, will measure infectious disease, genetic disease and toxicity of different virus, so as to ensure the cell products are safe and harmless. Prepare course while being whole, must go on, operate in high aseptic laboratory of standard by professional personnel, and establish the system of intact quality control to control." norm " requires clearly, launch the medical organization that is transplanted treatment technology of cell, must have, check and approve registration, accord with clinical cGMP of requirement by the intersection of pharmaceuticals administration and department ' Standardard management of quality of production of dynamic medicines) Standard cell centre and corresponding corollary equipment, the relevant apparatus with relevant instrument and cell products quality control of medicine density measurement of blood. It must be according to the cell products quality control standard sanctioned that cells prepare the laboratory, carry on to find strictly bacterium, fungi, mycoplasma, endotoxin,etc. to every the intersection of batch and the intersection of cell and products. Require the cell purity to be be greater than 70% at the same time, the cell activity is greater than 85%, purity and one have already reached the clinical application level, measure cells and possess normal function and biological effect outside the body." norm " still requires, cells prepare the laboratory there are advanced and overall persons in charge of the post qualifications of the above professional technique at least, engaged in the attenbant whose cell prepare has cell biological background and research experience, have no less than 50 experimental cell prepare experience, prepare relevant professional system, train and examine qualified through cell.The hospital of the first, second and third could launch this technology"Have good things, use to place, could play a good role. " Professor Wang FuSheng points out, the high-quality cell products prepared in the laboratory, infuse to the patient in the body, can give play to the best result in clinical practice, still depend on the scientific and normal decision of the clinician with enough experience, hold indication and taboo disease strictly. This reflects in " norm " directly too." norm " proposes, the clinician should strictly observe cells and transplant the operation regulation of the treatment technology and guide of making a diagnosis, judge synthetically that makes and treats the measure according to factors such as patient's condition, optional healing solution, patient's economic endurance,etc., construct and cure due to illness, treat rationally, know cells and transplant clinical practice indication and taboo disease of the treatment technology strictly.Expert point out cell transplant divide into until body transplant and allosome transplant two kinds, the two involve the ethics problem. So " norm " is still proposed, the hospital must have the cells composed of respects such as medical science, law, ethics,etc. expert to transplant clinical practice and ethics committee of treatment technology, and the standardard management, operation are normal. Transplant and treat cells, must be have cells to transplant to clinical practice ability of the treatment technology, on-the-job doctor of our institute with qualifications above the associate professor of treatment and propose by two the above, can implement after committee verifies ethics and passes.Also to launch cell transplant medical organization and employee qualification of the treatment technology, go on the restriction of the minimum standard " the norm ".According to the stipulations of " norm ", the medical organization which launches this technology must be the tertiary first rate hospital, there is subject of making a diagnosis related to employing cells and transplanting the treatment technology that health authorities check and approve registration, its engineering level reaches the key department's technical standard of the tertiary relevant specialized department of first rate hospital, in leading position in the tertiary first rate hospital of the province, autonomous region and municipality directly under the Central Government where one stays.The tertiary first rate hospital becomes " The thick stick of hard thick stick " . Han Zhongchao says, mainly the comprehensive strength based on tertiary first rate hospital is relatively strong for this restriction, can offer the intact medical scheme.The bad reaction needs to pay close attention toProfessor Wang FuSheng points out, " norm " is to launching the basic demand that cell medical organization and doctor that is transplanted treatment technology put forward. The constant and ripe and development of this technology also needs following up a case by regular visits to for a long time through clinic, and take the lasting control that security, validity, bad reaction,etc. various clinic comment on.Should say technological security by he and long-term two respect weigh from recently. For example carry on cell transplant, treat, patient have have a fever, symptom such as being irritated, perhaps shock takes place in the specific and serious one even dies etc.; Whether will cause the emergence of chronic immune disease and tumour in the long term, or situations such as the damage of important internal organs such as the kidney of liver,etc.,etc.. These two respects need clinicians to pay close attention to.In appraisal of the validity of clinical curative effect, for the quantity of cells in treating and offer the route; Cells are in internal surviving time; Whether planting into cells can contribute, how is the function size, whether have side effects to the important internal organs, need to follow up a case by regular visits to for a long time, set up and improve curative effect and assess the index. Various bad reactions that may appear after in addition need to pay close attention to that treat. Through the comprehensive appraisal on clinical curative effect, offer scientific basis for the improvement, development of the cell transplantation treatment technology.Wang FuSheng proposes, the responsible institution of the hygiene can organize Committee of Experts alone, conduct supervisor and guidance on the norm implement the situation fixedly or irregularly, organize experts to transplant further thinning norms of professional technique question such as indication of the treatment technology, clinical application scheme,etc. to cells at the same time, and subdivide and manage yardstick to the public's healthy extent of injury according to disease.
|