!supportFootnotes]>[73].

            Australian laws, like the United States, vary state-to-state.  Cell lines are only harvested from IVF embryos frozen prior to 2002[74].  They are now allowed research on any frozen embryos with proper consent and ethical review[75].  In Israel, researchers can use embryonic stem cells from frozen embryos, but egg donation and SCNT is not allowed[76].

            Austria and Germany contains much more restrictive laws.  Religious views, a legacy of eugenics, and negative attitudes towards new technology are believed to be responsible for these restrictions[77].  German scientist can only work on human embryonic stem cell lines derived in labs outside of Germany that were derived prior to 2002, and Federal law prohibits the derivation of any new human embryonic stem cell lines[78]. Germany’s European Commission on stem cell research contributions end up funneled into countries with more liberal policies, meaning that they are indirectly funding research in other countries that is illegal in Germany[79]. 

            With such a great variation in international and even national policies, it can be confusing as to what scientific practices are allowed within in any given geographical boundary.  The Hixton Group comprised of 60 bioethicists and stem cell researchers from 14 countries are advocating for consistent policies between nations[80].  The group believes that it is vital to address restrictions placed on stem cell research and fears that these restrictions are hampering the progress of science and complicating the ability for scientists to conduct stem cell research across national boundaries.  For instance, a German stem cell researcher working in the U.K. “would be committing a criminal act under German law” because such research is prohibited in Germany[81].  The purpose of ethical guidelines for stem cell research released by the group is to clarify conflicting international policies[82].  The Hixton group asks journals to require researchers to confirm findings and to correspond with national guidelines as well as establishing a public website for researchers to share their findings.  While the Hixton group guidelines would not replace laws already set in place, they would “codify basic rules of acceptable behavior in many jurisdictions that lack stem cell laws[83]. 

 

Current Research

            One of the most exciting breakthroughs in stem cell research is that scientists at WiCell Research Institute, a private lab affiliated with the University of Wisconsin- Madison, recently developed a precisely defined stem cell culture system that is completely free of animal cells.  Using this new culture system, the WiCell Research Institute created two new human embryonic stem cell lines.  By completely ridding the culture medium that stem cells are grown in of animal products, the chance of harboring dangerous viruses or deleterious agents in the animal cells are completely eliminated.  The ability to grow stem cells in cultures free of animal products has been a topic of debate over the federal funding for additional stem cell lines, and by having this new culture medium available, stem cells have become closer to a clinical reality.  “Derivation and culture of serum-free, animal product-free, feeder-independent conditions mean new human (embryonic stem) cell lines could be qualitatively different from the original lines, and makes current public policy in the U.S. increasingly unsound,”  authors of Nature Biotechnology Report conclude[84].  Currently 2 new stem cell lines using the WiCell Research Institute medium have survived from more than 7 months[85].

            Other research that is leading scientists closer to understanding stem cells has occurred at the University of Edinburg.  Edinburgh scientists have shown that a protein Mbd3 plays a crucial role in the process that causes embryonic stem cells to become specialized cells.  This new information helps scientists understand how embryonic stem cells can be made to become a specific type of cell within the body.  Mbd3 is part of a large complex of proteins called Nucleosome Remodeling and Histone Deacetylation Complex, or NuRd, which is known as an epigenetic silencer as its role in cells is to turn genes off.  Edinburgh scientists made mouse embryonic stem cells lacking Mbd3 protein, and the Mbd3 lacking cells failed to form different cell types, leaving the stem cells in an uncommitted state.  If Mbd3 is absent, cells remain in an embryonic stem cell-like state[86].  With additional research, scientist may be able to use this information in the creation of therapeutic treatments using adult stem cells where embryonic stem cells were traditionally believed to be the best. 

            At the University of Rochester Medical Center, a study was launched on January 26, 2006 to investigate whether transplanted stem cells can be safely used to treat damaged heart muscle after a patient’s first heart attack.  Researchers are optimistic that cellular cardiomyopatsty, the use of stem cells to replace lost heart muscle cells, will prevent the loss of heart muscles after a heart attack.  The treatment is measuring the efficacy of 3 IV doses of adult human stem cells versus placebo in decreasing the damage to heart muscle within 10 days of a first heart attack and has been approved for a new study.  The study seeks to ensure that stem cell therapy is safe in treating heart failure.  The new study is a randomized, double-blind, placebo-controlled Phase I clinical trial with patients randomized to receive injections of either .5 million, 1.6 million, or 5.0 million cultured adult mesenchymal stem cells per kilogram of body weight or the placebo.  The trial is being conducted according to US FDA guidelines to evaluate the safety of treatment of stem cells obtained from healthy, unrelated adult donors.  Experts think that mesenchymal stem cells or MSCs have the potential to be a powerful new treatment in cardiology.  MSCs, like Blood Type O, are universally compatible and are transplanted without the risk of rejection.  Generating MSCs can be expensive, time-consuming, and produce a limited number of cells in culture, however, MSCs can be donated by other humans leaving the possibility for storage of stem cell supplies that would be ready for use as heart attack patients arrive at hospitals.  At this time MSCs are already used in the treatment of some cancers.  While MSCs do offer some hope to heart attack victims, there are still several complications that may keep them from being a standard treatment offered in hospital emergency rooms.  The MSCs hone in on damage for only a short period of time following the injury, so treatment must be administered as soon as possible after a heart attack.  Also, implanted stem cells are shown to only partly differentiate and the end result lacks some characteristics of mature heart muscle cells.   Finally, most implanted MSCs either re-enter the circulatory system or die rather than engraft to the heart muscle wall[87].

 

Current Obstacles

            The potential to treat degenerative disease using stem cell technologies seems to be very promising, which may leave many people to question why the scientific community isn’t pouring more time and resources into stem cell research.  In addition to ethical and moral issues and current legislative restrictions as mentioned previously in this chapter, there are other issues that leave the scientific industry hesitant to dedicate more time to stem cell research.  The issue of intellectual property within stem cell research has been an issue that has not been addressed[88].  One of the most frustrating aspects of stem cell research is the recent and expected explosion of patents in the stem cell field which may block scientists from developing new treatments.  Restrictions resulting from new patents discourage researchers from pursuing particular line of inquire and slows the pace of stem cell research[89].  It has been suggested that institutions such as the California Institute for Regenerative Medicine (CIRM) require all grant recipients to agree to donate exclusive license to any “insights, materials and technologies” that they discover through their research and patent them to a common open source patent pool that would be administered by a new non-profit organization[90].  The patent pool would then serve as a one-stop shop for investigators to obtain no-cost or low-cost licenses for new research.  These open source patent pools would stimulate innovative stem cell research[91].

            Currently there has been little discussion of the regulation that will govern the results of research as the medical field attempts to move stem cell therapies from the laboratory to physician’s offices.   Any future regulation must reassure the end-users, both patients and health care providers that the stem cell products reliably satisfy a medical need without creating unnecessary cost or moral concerns[92]. End-users will also need to be reassured that treatments are not detrimental to their health and that the treatments do not carry any infectious diseases.   It is also important that new regulations reassure those who supply raw materials and labor for stem cell research that this industry is beneficial for them to participate in while encouraging responsible manufacturing[93].  

            Once stem cell therapies have been created, additional hurdles will remain.  Before any new medical treatments can be used in the U.S. they must first be approved by the FDA.  The safety and effectiveness of new treatments must be proved through clinical trials that demonstrate that the drug or treatment performs as it is claimed to do.  Clinical trials are costly to conduct, and require the funding of private sectors[94].  During a recent clinical trial, a virus activated a cancer-causing gene, and as a result, the FDA is not currently approving gene-therapy clinical trials[95].

            Scientists are also concerned that existing stem cell lines have been shown to accumulate genetic mutations with time.  With these genetic mutations, it is very questionable that stem lines currently available would be eligible for therapeutic use[96].  Additional concern is the social impact that stem cell technologies may have around the world.  Minority and ethnic groups are unlikely to benefit equally from stem cells as stem cell banks do not include less common tissue haplotypes[97].  More stem cell lines need to be created in order to ensure a broad diversity that will better match patients appropriate stem cells, and  for scientists to gain a more comprehensive understanding of human disease as it affects people with different genetic backgrounds[98].

 

Potential Impact on Public Health

            Scientists think that stem cell research is important to the future of medicine because with adequate research, stem cells have the potential to treat degenerative conditions by transplanting human stem cells into patients.  Presently, many of these chronic conditions have no cure and are managed by treating the symptoms.  While the initial cost of receiving stem cell therapy may be high, it has the potential to outweigh the life long costs encured through daily medications and hospitalizations.  By making disease management easier, the quality of life for those diagnosed with this diseases and their family members would be greatly included.  With sufficient development of stem cell medicine, chronic diseases such as diabetes, heart disease, and Parkinson’s disease will be effectively managed.

            Diabetes is a chronic disease with severe complications including increased risk for limb amputations and vision loss ,and currently there is no cure.  The world-wide estimate of individuals with diabetes in 200 was 177 million people, and that number is expected to reach 300 million by 2025.  Deaths attributed to diabetes is reported to be over 800,000 but many experts argue that this figure is grossly underestimated and should be closer to 4 million deaths per year which is nearly 9% of the world population[99].  Managing the disease often involves drastic changes in lifestyle in additions to daily medication and medical monitoring.  It was estimated that the total annual economic cost of diabetes in 2002 was approximately US$132 billion or approximately 1 out of 10 health care dollars spent in the U.S.[100].  With more research, future treatments may include transplanting insulin-producing pancreatic beta cells, eliminating the need for daily medications and reducing the risk of diabetes related complications.

            Nearly 1 in a million people in the U.S. are diagnosed with Parkinson’s disease.  Parkinson’s disease is a movement disorder with symptoms that include debilitating tremors that continue and worsen with time.  Patients diagnosed with Parkinson’s disease take a variety of medications in different doses to manage the symptoms of the disease.  The varieties of medications are often confusing, causing individuals to miss doses.  While the surgical option of Deep Brain Stimulation has been shown to decrease the severity of the symptoms, the treatment is not successful for all patients[101].  Stem cell therapy may reduce and prevent the progression of Parkinson’s symptoms when destroyed dopamine-secreting neurons are replaced, improving the patient’s quality of life and reducing drug costs. 

            More than ½ million Americans suffer have their first heart attack every year, resulting in injury to the heart and scarring that contributes to the gradual loss of the heart’s pumping strength[102].  Of the 1.5 million heart attacks per year in the U.S., approximately 500,000 result in fatalities. If that number doesn’t open your eyes, nearly 14 million Americans have a history of heart attack or angina, and the costs related to heart attacks exceed US$60 billion per year[103].  While stem cell research has not yet proposed that they will be able to reduce the occurrence of heart attacks, it is believed with refinement of current research, doctors may be able to someday reduce damage to the heart muscles is stem cells are administered after a heart attack.

 

Conclusion

            While the benefits of stem cell research may seem to be out of reach for the immediate future, with continued research , stem cell therapies are predicted to one day be a common treatment for degenerative diseases.  In order for this field to be successful, researchers must collaborate and share limited resources.  With increases in funding and continued interest from private investors, stem cell research is expected to evolve rapidly in the next decade.

 

 

For More Information

These websites and journals are helpful in obtaining more information about stem cell research:

Institute for Stem Cell Research (ISCR)- www.iscr.edu.ac.uk

The Journal Regenerative Medicine www.futuremedicine.com

NIH Stem Cell Information Home Page: www.stemcells.nih.gov

American Association for the Advancement of Science:  www.aaas.org

Stem Cell Policy: World-wide Stem Cell map: http://mbbnet.umn.edu/scmap.html

 



[1] http://www.aaas.org/spp/cstc/briefs/stemcells/index.shtml

[2] Ibid

[3] Ibid

[4] www.stemcells.nih.gov

[5] www.stemcells.nih.gov

[6] Ibid

[7] Powerful Technique For Multiplying Adult Stem Cells May Aid Therapies.  January 23, 2006.  Retrieved from :  www.medicalnewstoday.com

[8] Russo E (2005) Follow the Money- The Politics of Embryonic Stem Cell Research.  PLoS Biol 3(7): e234

[9] Powerful Technique For Multiplying Adult Stem Cells May Aid Therapies.  January 23, 2006.  Retrieved from :  www.medicalnewstoday.com

[10] www.stemcell.nih.gov

[11] Russo E (2005) Follow the Money- The Politics of Embryonic Stem Cell Research.  PLoS Biol 3(7):e234

[12] Russo E (2005) Follow the Money- The Politics of Embryonic Stem Cell Research.  PLoS Biol 3(7):e234

[13] Ibid

[14] Ibid

[15] Cloned Stem Cells and Fertilized Stem Cells Identical.  January 17, 2006.  Retrieved from: www.medicalnewstoday.com

[16] Russo E (2005) Follow the Money- The Politics of Embryonic Stem Cell Research.  PLoS Biol 3(7):e234

[17] Cloned Stem Cells and Fertilized Stem Cells Identical.  January 17, 2006.  Retrieved from: www.medicalnewstoday.com

[18] Ibid

[19] www.stemcell.nih.gov

[20] Ibid

[21] Ibid

[22] Ibid

[23] Powerful Technique For Multiplying Adult Stem Cells May Aid Therapies.  January 23, 2006.  Retrieved from :  www.medicalnewstoday.com

[24] Ibid

[25] Cloned Stem Cells and Fertilized Stem Cells Identical.  January 17, 2006.  Retrieved from: www.medicalnewstoday.com

[26]  Cloned Stem Cells and Fertilized Stem Cells Identical.  January 17, 2006.  Retrieved from: www.medicalnewstoday.com

[27] Liddell, Kathleen and Susan Wallace.  Emerging Regulatory Issues for Human Stem Cell Medicine.”  Genomics, society and Policy 1.1. (2005) : 54-73.

[28] http://www.aaas.org/spp/cstc/briefs/stemcells/index.shtml

[29] http://www.aaas.org/spp/cstc/briefs/stemcells/index.shtml

[30] Ibid

[31] Ibid

[32] Liddell, Kathleen and Susan Wallace.  Emerging Regulatory Issues for Human Stem Cell Medicine.”  Genomics, society and Policy 1.1. (2005) : 54-73.

[33] Group Releases Ethical Guidelines on Stem Cell Research to Clarify Conflicting International Policies.  March 2, 2006.  Retrieved from:  www.medicalnewstoday.com

[34] Critchley, Christine and Lyn Turney.  “Understanding Australians’ Perceptions of Controversial Scientific Research.” Australian Journal of Emerging Technologies and Society 2.2 (2004) ; 79-140.

[35] Stem Cell Research: Legal and Ethical Questions.  March 1, 2006. Retrieved from www.medicalnewstoday.com

[36] Ibid

[37] Ibid

[38] http://www.aaas.org/spp/cstc/briefs/stemcells/index.shtml

[39] Ibid

[40] Ibid

[41] http://www.aaas.org/spp/cstc/briefs/stemcells/index.shtml

[42] Ibid

[43] Ibid

[44] Ibid

[45] Ibid

[46] http://www.aaas.org/spp/cstc/briefs/stemcells/index.shtml

[47] Ibid

[48] Ibid

[49] Wisconsin Scientists Grow Two New Stem Cell Lines in Animal Cell-free Culture.  January 2, 2006.  Retrieved from:  www.medicalnewstoday.com

[50] Ibid

[51] http://www.aaas.org/spp/cstc/briefs/stemcells/index.shtml

[52] National Academy Of Sciences To Create Privately Funded Embryonic Stem Cell Research Committee.  February 20, 2006.  Retrieved from:  www.medicalnewstoday.com

[53] Ibid

[54] President Bush Signs Bill Authorizing Funding for Establishment of Umbilical Cord Blood Network.  December 22, 2005.  Retrieved from:  www.medicalnewstoday.com

[55] Ibid

[56] Russo E (2005) Follow the Money- The Politics of Embryonic Stem Cell Research.  PLoS Biol 3(7):e234

[57] Ibid

[58] Ibid

[59] Russo E (2005) Follow the Money- The Politics of Embryonic Stem Cell Research.  PLoS Biol 3(7):e234

[60] Ibid

[61] Broad Foundation Donates $25 Million to Create New Stem Cell Institute at USC.   February 25, 2006.  Retrieved from: www.medicalnews.com

[62] Radical Proposal to Speed Development of Stem Cell Therapies.  March 1, 2006.  Retrieved from : www.medicalnewstoday.com

[63] Russo E (2005) Follow the Money- The Politics of Embryonic Stem Cell Research.  PLoS Biol 3(7):e234

[64] Ibid

[65] Ibid

[66] Liddell, Kathleen and Susan Wallace.  Emerging Regulatory Issues for Human Stem Cell Medicine.”  Genomics, society and Policy 1.1. (2005) : 54-73.

[67] Ibid

[68] Ibid

[69] Russo E (2005) Follow the Money- The Politics of Embryonic Stem Cell Research.  PLoS Biol 3(7):e234

[70] Ibid

[71] Ibid

[72] Ibid

[73] Ibid

[74] Russo E (2005) Follow the Money- The Politics of Embryonic Stem Cell Research.  PLoS Biol 3(7):e234

[75] Ibid

[76] Ibid

[77] Ibid

[78] Ibid

[79] Ibid

[80] Group Releases Ethical Guidelines on Stem Cell Research to Clarify Conflicting International Policies.  March 2, 2006.  Retrieved from:  www.medicalnewstoday.com

[81] Group Releases Ethical Guidelines on Stem Cell Research to Clarify Conflicting International Policies.  March 2, 2006.  Retrieved from:  www.medicalnewstoday.com

[82] Washington Post Examines Scientists, Ethicists Proposing International Stem Cell Research Guidelines.  March 6, 2006.  Retrieved from: www.medicalnewstoday.com

[83] Ibid

[84] Wisconsin Scientists Grow Two New Stem Cell Lines in Animal Cell-free Culture.  January 2, 2006.  Retrieved from:  www.medicalnewstoday.com

[85] Ibid

[86] Edinburgh Scientists Identify a Key Player in Making Specialized Cells From Embryonic Stem Cells.  February 8, 2006.

[87] Stem Cell Study Seeks to Prevent Heart Failure.  January 26, 2006.  Retrieved from: www.medicalnewstoday.com

[88] Stem Cell Research: Legal and Ethical Questions.  March 1, 2006. Retrieved from www.medicalnewstoday.com

[89] Radical Proposal to Speed Development of Stem Cell Therapies.  March 1, 2006.  Retrieved from : www.medicalnewstoday.com

[90] Ibid

[91] Radical Proposal to Speed Development of Stem Cell Therapies.  March 1, 2006.  Retrieved from : www.medicalnewstoday.com

[92] Liddell, Kathleen and Susan Wallace.  Emerging Regulatory Issues for Human Stem Cell Medicine.”  Genomics, society and Policy 1.1. (2005) : 54-73.

[93] Ibid

[94] Radical Proposal to Speed Development of Stem Cell Therapies.  March 1, 2006.  Retrieved from : www.medicalnewstoday.com

[95] Powerful Technique For Multiplying Adult Stem Cells May Aid Therapies.  January 23, 2006.  Retrieved from :  www.medicalnewstoday.com

[96] Wisconsin Scientists Grow Two New Stem Cell Lines in Animal Cell-free Culture.  January 2, 2006.  Retrieved from:  www.medicalnewstoday.com

[97] Liddell, Kathleen and Susan Wallace.  Emerging Regulatory Issues for Human Stem Cell Medicine.”  Genomics, society and Policy 1.1. (2005) : 54-73.

[98] Wisconsin Scientists Grow Two New Stem Cell Lines in Animal Cell-free Culture.  January 2, 2006.  Retrieved from:  www.medicalnewstoday.com

[99] www.who.int/mediacentre/factsheets/fs236/en

[100] www.diabetes.org

[101] www.pdf.org

[102] Stem Cell Study Seeks to Prevent Heart Failure.  January 26, 2006.  Retrieved from:

www.medicalnewstoday.com

[103] www.womensheartfoundation.org