First note

Concise Review: Mind the Gap: Challenges in Characterizing and Quantifying Cell- and Tissue-Based Therapies for Clinical Translation.

ERIN, A. R. & DAVID, J. W. (2010). Stem Cells

Cell medicine has potential to diagnose and cure some disease conditions where current medical approaches are inefficient. Cells in cell therapy must be proliferated and purified in sterile conditions with high quality processes, effective and potent. These challenges require more stringent and specific culture conditions if they originated from animal tissue sources. Cell specification is the first step and after identification of a potential cell/tissue-based therapy by clinical trials, all process in the product safety must be considered. This includes sterility testing for microbiological agents (aerobic and anaerobic bacteria), fungi, mycoplasma, virus and endotoxin with. In addition, animal sources components of cell culture media are increased body’s immune responses to cell/tissue-based products which promote the risk of rejection due to the use of immune suppression agents, so fewer HLA mismatches may lead to better cell/tissue acceptances. On the other hand, since the requirements of large number of cell amplification, the risk of genetic changes is increased that should be assessed by karyotype testing to ensure chromosomal stability. Finally, as a result of the contamination risk by undifferentiated cells, these undifferentiated unwanted calls will need to be removed before patient treatment. Cell potency and proper characterization of efficacy which are related to safe dosages, cell number and cell viability could be measured by effective cell-specific tests. The main problems of freezing (slow: replacement of water with cryoprotectant and fast: using liquid nitrogen) are loss of cell numbers, decrease cell viability and slow growth curve. Purity of manufacture of cell proliferation, differentiation or activation are distinguished by cell surface and intracellular markers, however most of these are not specific. Master cell bank (MCB) should be mentioned cell origin, standard operating procedure, cell markers, sterility and thawing methods. All three main stages of general test processing for cell/tissue-based therapy including safety, efficacy and purity have been shown below:

Then, the final products will be approved by FDA methods which are mentioned in this article and finally will prepare for commercial use.

اين مقاله، به درمان سلولی اشاره دارد. در حال حاضر، درمان سلولی، به عنوان يک راهبرد جديد  در درمان  برخی بيماريها استفاده می شود که کاربرد آن نيز روز به روز بيشتر می شود. در اين مقاله به اشاره به پتانسيلهای اين رويکرد جديد درمانی، به محدوديتهای آن اشاره و در قالب طراحی يک پروفايل، درمان سلولی را کاربردی می کند. يعنی مثلا، در ابتدا سلول مربوطه تحت بررسی و کنترل باکتريايي، ويروسی وقارچی قرار گيرد، در مرحله بعد امکان تکثير و درجه خلوص آن چک شود و ...

البته، در قالب يک جدول، که اگر در هر مرحله، نتايج موفقيت آميز بود، به مرحله بعد می رود. بنظرم، آينده پزشکی نوين، در قالبی شبيه به همين موارد است. اگر بيشتر علاقمند بوديد، اين عناوين را در اينترنت جستجو کنيد. Cell Medicine, Molecular Medicine

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