While studies of the effects of mouse embryonic stem cell can be modified in specific genes in most mammals. Scientist for decades has been breaking down the doors as to the DNA, RNA of not only mammal genetics but humans as well. There is correlation finally between humankind's genetic genes and mouse genes that are ninety-nine percent relative in comparison.
Stem cells are essential for every living organism for many reasons and that is within 3 to 5 days the inner cells start the nucleus of life. The cells that are specialized in this time frame include heart, lung, skin, and tissue. Given the unique regenerative ability, the cells that are taken from embryonic stem cells offer new potential for treating diseases in cardiology, gastroenterology, and immunology. By discovering how the cell reproduce rapidly during normal development or even during abnormal cell division that leads to various diseases.
The surveys that are conducted are essential to collaborate each patient diagnosis in comparison with other treatments that have failed over the course of months or years as regards to drug treatments and therapies.
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The information provided within this paper will not only help patients in need of new therapies but also help the general doctors in offices across the country in prevention methods. In addition, the information provide in this paper for the layman eyes will be able to give knowledge that scientist are not in the business in cloning humans but only from the use of embryonic stem cells that are crucial and key to each mammal and human life.
Research Question and Hypothesis
How will gene trapping or gene targeting technology utilize mice embryonic stem cells for drug treatments in cardiology, gastroenterology, and Immunology? Scientist has for decades have been breaking down the doors as to the DNA, RNA of not only mammal genetics but humans as well. There is correlation finally between humankind's genetic genes and mouse genes that are ninety-nine percent relative in comparison.
Not only has biotechnology been advanced in the last fifteen years it has evolved into more complex avenues into developing new advance drug treatments and therapies. Furthermore, developments that are more recent scientist have been able to target embryonic stem cells from mice by extracting the DNA, as well as RNA genes. Once the good genes are identified, it can be reinserted into the female mouse that will produce offspring with only the good genes to target any bad genes and replicate.
Moreover, what is known as a chimeric mouse scientist are able to mate this mouse and normal mouse and from there eventually a healthy mouse. The role of this specific gene development known as knockout mice technology has revolutionized the theories of life, which will show that by doing so new development of medical drug therapy, pathology, and physiological re-growth of damaged tissues.
Even now new drugs are being developed and targeting such diseases as Cardiology muscle tissue, Gastroenterology and Immunology as to therapies or treatments. New drugs have even reach second stage clinical trials, which mean patient surveys in general are being sought on all fronts relating to Cardio muscle repair, gastroenterology as to Irritable syndrome and immunology as to arthritis for testing by volunteer patients. All this will benefit general doctors and specialist in new drug technology and treatments for patients.
Researchers in the biotechnology field that is connected to genetics, and diseases in their quest of understanding and developing new drugs for various diseases as well as cures for mankind. By understandings the development of the human gene mechanism the scientist use mice known as "knockout mice" (Lexicon, 2010), in order to understand how genes react and can be reactive in gene trapping and therapy. One reason why the mice are used is that 99 percent of the human genes have a mouse counterpart as to the physiology that it was recognized with the Nobel Prize winners in medicine.
Current literature will support this new technology by 2007 Nobel Prize winner Barry Sharpless that by using molecular chemical compounds that demonstrated drug like characteristics that involve in vivo for discovery purpose. The knockout mice that are used actually serves as a guideline in preclinical and clinical developments in the lead molecules. By utilizing in vivo meaning experimentation of living organisms whereas in vitro meaning artificial environment that is outside living organisms.
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Also to prove such aspects of this development Doctors Mario Capecchi, Martin Evans, and Oliver Smithies who also won the 2007 Nobel prize in physiology or medicine developed gene targeting that utilize knockout mice technology and is applied in all areas of biomedicine and new therapies today.
With the use of gene trapping and targeting results in the culture isolation of mouse embryonic stem cell the specific gene is deleted and once identified the good cells are re-injected back into the mouse embryo thus creating a new mouse without any genetic deficiencies that are analyze for any possible mutations or problems.
The technology can also replace DNA of the embryonic stem cell that can generate alterations, analyze its functions, and replace it with a human gene in preclinical research for developing any therapeutic discovery. Moreover, with such targeting that is 100 percent specific and potent in this develop technology the uses are being identified in "cardiology, immunology, and gastroenterology" (Lexicon, 2010). Now with the cardiology research the development in recognizing LDL or bad cholesterol, and the triglycerides that are increased in patients with coronary artery disease is ongoing. Other aspect is being targeted to metabolic syndrome such as stroke and type 2 diabetes.
The immunology discovery that has been discovered and being developed has targeted an enzyme missing in the thymus and spleen that circulates in blood system for those with inflammatory disease associate with arthritis and autoimmune disease like rheumatoid arthritis. By increasing this enzyme in mice, the scientists have reduced the T, and B cell production of lymphocytes that attack the body's own tissues.
In gastroenterology, which is being studied as to irritable bowel syndrome as well as tumors associated that is severe to cause other problems such as "rapid heartbeats, facial flushing, severe diarrhea, and bronchial restrictions" that are release into bloodstream with an uptake of serotonin in the GI tract. A new enzyme after targeting the gene responsible in the GI tract is the same as in the brain, which is serotonin, and such development has resulted in separating the two levels of serotonin without disrupting the serotonin in the brain.
Test subjects are then utilized as to new drug and treatment therapies before final approval. Now with the test subjects of humans no numbers were actually given as to a quantitative notion even though a qualitative as to the methods used and making sense as to what is to be accomplished.
Now according to (Greg Davis, Trevor Collingwood, and Phil Simmons of Sigma -Aldrich, 2008) have stated that by using genetic manipulation and ionizing radiation to make alterations to the gene functions. They believe that by utilizing this method is quicker than what have been previously stated due to low efficiency and the use of donors DNA to specific targets. Meaning not waiting 3 to 6 days to get results of the gene affected.
They contend that the study of zinc fingers that is "composed of two functional domains and structures of 30 amino acids that are held by the zinc ion" (Greg Davis, Trevor Collingwood, and Phil Simmons of Sigma -Aldrich, 2008) can be cut. As they see it, this process leads to multiple finger proteins through the DNA process by cutting strands of molecular DNA. They believe that a selected marker of a deficient gene was unnecessary at the DNA level. The contention is to target such genes at a high frequency rate by targeting the whole DNA strand. They found out by editing the DNA molecular compounds as to the deficient gene the cell lines in animals, and plants will create new drugs and cure human diseases. By inducing changes in human stem cell, the genetics will be change. They do not elaborate on the technology, as does Lexicon pharmaceuticals in to specifics relating to cardiology, immunology, or gastroenterology. Their main concern is manipulating the DNA through short deletion and insertions that would disrupt a functional gene.
With such statements by (WellTrust, 2003), is that knockout mice are widely used to study human diseases due to the fact their genes and humans are similarly close. This where knockout mice are inseminated artificially without any gene preselecting to study the loss of gene functions by just swapping the functional gene for the mutated gene in the embryonic stems of cells. They also contend that by using the embryonic stem cell early on they can watch the growth at different stages of the mutant gene as well as the deleted gene in through the embryo process of development.
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The important roles this will target genes to see what is causing that genes functions thus eliminating the particular gene and reinserting the good genes back into the embryo. The fact is by studying why and how better to utilize the gene due to its lack or loss of functioning will only help in determining the physiological and the biomedical disease in either producing better drug therapies or tissue rejuvenation of damaged areas.
According to (GenOway, 2006) their objective is to gather functional neurons, fat storing cell which will help in manipulating the genes for utilization of knockout and knock in mice. This will help ensure the screening of new drugs in metabolic disorders, immunological causes and targeting treatment of diseases. The company uses DNA pronuclear injection of the modified cell back into the mother's womb that will produce an offspring of the deleted diseased gene.
A newer DNA transgenesis technology is now aimed at the DNA pronuclear injection will allow an in vitro type preselecting of characteristics of the genes, which will allow shorter development times and cost. This is in contrast to the classical DNA transgenesis, which is modifying level of the transgene at the integration site.
In other words by targeting the gene faster in vitro will generate a faster new embryonic cell minus the disease gene. This will help in tissue growth as well as targeting bad genes in attacking and destroying those gene cells with the body. As with Lexicon pharmaceuticals test subjects were used but no notation as to quantitative research only qualitative methods of the subjects.
With all the technology as to embryonic stem cell to locate and study the disease cell and then by re-inserting the gene free of the disease, back into the mouse or the mother's womb will attack the other disease cells in reproducing more good cells and thus damaged tissue in the long run. The technology that will be gain in such development will reduce cardio and immunological disease that attack good genes and destroying cells.
As to any flaws in this research, I found that Greg Davis, Trevor Collingwood, and Phil Simmons of Sigma -Aldrich were more biased as that their development was better where as Lexicon pharmaceuticals came across with testing in a more depth perspective. This is in regards to gene trapping and targeting genes of the embryonic stem cell for rejuvenation of damaged tissue and new drug therapies for humanity.
As to WellTrust, they seemed similar in nature yet inconclusive as to the degree and nature of Lexicon and GenOway in their testing of embryonic stem cell as to gene targeting and pinpointing specific genes and its mutations to further enhance the ability of making new drug treatments and therapies.
The main difference was between Lexicon and Sigma -Aldrich where Sigma was utilizing the amino acid structure and ionizing radiation of the genes makeup which if the embryonic stem cell was missing amino acid one it could be infused back in or by ionizing radiation of cutting that particular strand of DNA. Whereas Lexicon pharmaceuticals trapped, and targeted the gene in the embryonic stem cell that was damaged by eliminating that gene all together. The researchers then reinserted the gene back into the embryo thus producing a healthier entity or tissue organ.
The only ethical issue that I read was the use of either test subjects Lexicon and GenOway were given a placebo or the actual drug that was used in the knockout mice to combat the mutant gene. Subjects of the test were not told what was what in either case in conducting such reviews. The ethical question is should test subjects be told as to what the drug is for and how long it will last in a blind study. Granted as you read this you can tell they were utilizing complete observation of the test subjects and what the qualitative and quantitative aspects are. The other two research companies used qualitative methods as to mice and mutant genes.
The audience of this scenario would be geared towards medical doctors that could and would use such study for future patients whether prescribing drug therapies, treatments for patients. The method used for this report would be historical and ethnographic data. Since this report will look at historical data. Since, historical data looks at origins, theories, and growth with current trends and future possibilities. Collect most pertinent evidence and analysis, and drawing a conclusion.
With Ethnographic part of this research I am using publish and unpublished data such as paper, books, magazines, video's and public records regarding gender, age, and ethnic groups, along with subtype percentages that is associated with the study. Secondary Analysis for this research is needed since existing sources of data is needed and secondly can help the scope of study.
Therefore, before I would get started I need to identify the research question in addition do I have time and resources to conduct such a study. Next would be resources, types of equipment needed if any, and funding of the study are all key components for a study to be successful.
The research looks as to why mouse embryonic stem cells are used to studying a variety of genes that are closely related to human genes in the production of new drugs and therapies. First thing, we need to know what disease is being looked at. Secondly, after all your studies have been done on your mouse model to rule out most adverse effects of the gene, which eliminates the bad gene.
Third, we need to know what disease is being look at so if it is under the gastroenterology series like IBS we need the percentage of age groups, ethnic and
subtype symptoms of the disease. The same would go for any of the diseases as to the same format. Fourth, compile a randomized cross section of patients from various doctor offices across the country that total number could be analyzed broken up into ethnic groups, ages, and gender for instance 100 or 200 patients may be needed for the test. Half could be given a placebo versus half the actual drug in patients.
As to what would be next is the reliability and validity of the information gathered. The reliability is how many times it has been repeated meaning the study, test and information. The validity of information regarding any study, test is how accurately a variable corresponds to what it is intended measure. All this followed by recording field f data followed by analysis field data.
Instruments and Data Collection
Instruments for the study included 150 surveys that where collect from doctor offices and specialist about patients that are good candidates for such clinical trials. The data collected used stratified sampling that incorporated a randomized cross sectional population to support their process at LCC Biotechnology.
By utilizing this method from a cross section of the population, you eliminate possibility of duplicating surveys and collecting as well as targeting just one area for your random sample survey as to possible physiological problems that maybe a contributory for such ailments.
Each patient was instructed to fill out the survey and return to his or her doctors, which were then mailed in to the staff at LCC Biotechnology. The surveys where collected and tabulated from the responses for these symptoms are subjective assessment of pain and discomfort; the assessment for each patient were collected on a weekly basis via clinical database research for 4 weeks which allowed researchers to rule out non participants to support their research in a quality assessment of values targeted for each patient.
Subject population in this study consisted of patients who were directed by doctors and specialist in the medical field. Furthermore, to effectively define the primary patients the survey is based on gender, age, ethnic background, education, and religion demographically for this study.
One hundred and fifty patients were randomized with an average age of 48 that range from 21 to 68 years of age. Sixteen percent were males and eighty-four percent were females. As regards to ethnicity 89.7 percent white, 7.7 percent African American, 0.6 percent Asian, while1.9 percent were mixed, or other. As to Irritable bowel syndrome, 23.9 patients were mixed and 76.1 patients had diarrhea.
As to education White males and Asian males percentage as to some high school respectively is 0.7/0.9,females 0.5/0.2 percent. As for black males with some high school and others or unknown respectively is 2.3/0.2, females 0.4/ 0.1percent.High school graduates again whites and Asian males percentages are fairly close with 10.6/9.1 respectively. Female high school graduates in this study where 9.2/11.3 percentages.
As to black males with high school degree compared to other or unknown respectively is 3.9/1 percent. Female black high school graduates compared to other or unknown 5/2 percent. As to bachelors degree white males to Asian males 4/5.4, female white to Asian 1.5/1.8 percent. Black male bachelor degrees to other or unknown 0.1/0.2 percent, female black to other or unknown 0.3/2 percent.
The survey went on for Master's and Doctorate degree with white males to Asian males was 3/2.2, females were 2/3.4 respectively. As for black males to other or unknown, the percentages were as follows 0.1/0.1, females 0.1/0.2 percent. In addition, white males with a doctorate degree and Asian males 2/2, females 0/2.3, for black males 0/0, females 0/0.
Other demographics that were taken into account for the survey was political format whether conservative liberal or independent. Reason for such avenue as to political aspects was to determine who would be best suited for such patient trials.
The data collection process occurred over the course of 4 months from January of 2009 - April of 2009. One hundred and fifty patients were determined to provide a substantial base for the applicable findings. The group of statisticians created a document representing the data in a quantitative format.
The standard deviations and means to represent the average and typical spread of values of variables have shown the precision of estimates. The outcome that was in the statistics as being 95% confident as to the limits that define the true value in the population from which we drew our samples from.
As to the numbers showing in one test irritable bowel syndrome (IBS), showed significant decrease in urinary protein abnormalities conducted over 14 days. The study of 150 volunteers value at p< 0.05 tolerated doses at all levels with no complications compared to other drugs used for constipation. At baseline, the placebo number was zero, at day five 3.45, day 10 showed 2.35 but when day 14 came 24.21. With 250 milligrams (n-6) administered again baseline showed 0 and day five showed -24.84, then at day 10 -20.66, and at day 14 -15.86. Lastly, at 1000 milligrams the baseline was at 0, day 5 -45.64, day 10 - 45.63, and at day 14 -36.59.
The study objectively studied the 150 patients (n=50/arm) whether changes in stool, urgency, frequency as well as severity which included urinary problems, discomfort, bloating and pain. Conclusion, over 14 separate meetings with patients was that the placebo showed (n=47), 250 milligrams showed (n=44), and at 1000 milligrams (n=43).
Broken down into terms for the nonprofessional is that the placebo percentages showed:
Safety Profile and Toxicology observed in patients
Blood Amylaise increase
White Blood cell increase
This shows that with the technology of knockout mice in formulating new drug technology in one example. The other test shows equal or better results. The significance of the assessment over the treatment period showed the placebo (P=0.0465). With patient improvement of 61 percent marked at a high dose over 45 percent placebo.
In examining, the data and all the results from other data that has been collected it clearly shows that the majority of genomics of embryonic research and studies of stem cells produced remarkable results in enzymes of cytosine deaminase that is capable of converting the nontoxic pro drugs into viable treatments as well as neutralize any harmful toxins. Plain and simple in laymen's terms is that once the stem cells embryo's where converted into essential proteins, and enzymes the results showed significant improvement in patients overall.
The challenges and difficulties with disease and injuries that previously have had no cure are the driving force behind stem cell research today. If disease and injuries never existed then there would be no heated debates over stem cell technology. The conventional approaches to therapy of the past were not promising but with the advent of stem cell, therapy offers likelihood of success.
With gene targeting concept that has transformed medicine as we see how genes interact between bad as well as good genes and the effects of once the bad gene is targeted and removed from the good genes are able to regenerate at a quick pace which has given scientist insight in to the developments. So far new drug technology and treatments are being testing in a variety of ways that include diseases that affect gastroenterology, immunology, as well as cardiology.
New technology in the biological genetics area as far as embryonic stem cell research will only better in developing response tissue re-growth that has led to diseased human pathologies to generate a tractable system in identification of new therapies and development of pharmacology drugs. This does not mean human cloning, as some believe it to be but advancement in understanding the genetic make-up of humans and mammals regarding tissue replacement of skin, cancer cures, and organ re-growth of muscle tissues.