It is now possible to develop new treatments and cures for human disease and eliminate suffering with stem cells.
The potential applications for stem cells are staggering. Today, there are 4,644 stem cell related clinical trials globally with 2,669 from U.S. companies alone. Of these, 528 are in the state of Texas (www.clinicaltrials.gov) at institutions like the Texas Biomedical Research Institute in San Antonio, the University of Texas Health Science Center at San Antonio and Houston, The Texas A&M Health Science Center College of Medicine Institute for Regenerative Medicine (IRM) and the Texas Heart Institute in Houston. As shown in figure 1, stem cell clinical trials are now far reaching with applications ranging from treatments for lymphoma to organogenesis – the creation of organs – to drug testing.
Totipotent cells, stem cells which retain the full potential to differentiate into any other kind of cell, have been invaluable in not only the study of developmental biology but in the creation of the first cloned mammals and cultured stem cells as well. The first in vitro (“in the laboratory”) stem cell lines were developed in mice in 1981 and in hamsters in 1988. In 1984, a Danish scientist by the name of Steen Willadsen cloned a sheep from embryonic stem cells. This was the first confirmed case of mammalian cloning. Two years later, Neal First, Randal Prather and Willard Eyestone of the University of Wisconsin cloned a cow from embryonic cells. Then in 1996, Ian Wilmut and Keith Campbell cloned Dolly the sheep. Her birth showed that it was possible to take cells from an adult animal, de-differentiate them and use them as stem cells to form a new embryo. Subsequently, in 1997, two Rhesus monkeys were cloned using stem cells combined with nuclear transfer at the Oregon Regional Primate Research Center. Due to the combined use of nuclear fusion, advanced embryo and cell culture techniques, and embryo transfer, numerous animals were cloned in the years that followed including mice, rats, rabbits, pigs, goats, sheep, cattle, Rhesus monkeys and many endangered and threatened species. These studies advanced our understanding of totipotent and pluripotent stem cells, and how they might be used to generate life-saving tissues for use in humans.
Because cloning and regenerative cell technology were moving closer to human application, they became very ethically and politically controversial. In 1997, President Clinton signed a five-year moratorium on the use of federal funds for human embryonic stem cell research. Although this greatly hindered the advancement of stem cell research, important stem cell research in animals and in some cases, humans, continued using private funds.
In 1998, it was proven that cancer stem cells existed in bone marrow and that these cells can cause cancer, namely “leukemia.” Soon after, it was shown that bone marrow stem cells could be induced to develop into alternative cell types such as nerve and liver cells. Researchers then found that brain tissue could also be induced to yield alternative cell types, demonstrating for the first time that it was possible to have scientific control over regenerative processes.
In 2000, additional government regulation hindered stem cell advancement. The National Institutes of Health (NIH) released guidelines for human pluripotent stem cell research. They indicated human embryonic stem cells must be derived from frozen embryos from fertility clinics using private funds, have been created for fertility treatment, be in excess of the donor’s clinical need, and obtained with the consent of the donor. Finally, these guidelines outlawed the Federal funding of stem cell research even if they were derived from embryos using private funds.
In 2001, then-President George H. W. Bush prohibited Federal funding of any research using stem cell lines derived after August 9, 2001, but his policy did not affect research in the private sector or research conducted with state funding. It was not until 2007 that Bush issued an executive order to the U.S. Department of Health and Human Services (HHS) to support and encourage pluripotent stem cell research.
In November of that same year, two scientists, independently and at different institutes – Shinya Yamanaka, Kyoto University and James Thomson, University of Wisconsin-Madison – injected human genes into pluripotent stem cells and induced these cells to become beating heart and nerve cells. In December 2008, the International Society for Stem Cell Research released its Guidelines for the Clinical Translation of Stem Cells, acknowledging the tremendous potential for the stem cell therapies for the treatment of human diseases and providing guidelines for stem cell experimentation, safety and efficacy testing.
Then, on March 9, 2009, President Obama reversed former President Bush’s 2001 executive order and removed the barriers to “Responsible Scientific Research Involving Human Stem Cells.” This action opened the gates for biomedical research with the first clinical trials of human embryonic stem cell therapy beginning in 2010. The FDA granted Advance Cell Technology, Inc. approval to test stem cell therapy for degenerative eye disease. In 2012, the NIH was legally able to fund research on human embryonic stem cells using cell lines derived from destroyed day-old embryos.
Stem cell research then progressed very rapidly. In 2013, scientists grew human stem cells from cloned embryos, and Japanese researchers grew human liver from human stem cells. Just this year, scientists from London’s Royal Free Hospital as well as others from around the world made body parts and organs from human stem cells. Adult stem cells are currently being used to treat many conditions such as heart disease and leukemia. Fetal cord blood transfers (containing stem cells) have also show great promise in the treatment of blood related diseases.
Today, we are on the edge of a new era medicine in which stems cells will be used to cure human diseases yet beyond our imagination. Through this, it is important to know that we would not be at this historical threshold without the arduous ground breaking efforts of those pioneering scientists of the last 25 years.
Jane C. Andrews, Ph.D., is a Senior Consultant with Frost & Sullivan’s Health Care & Life Sciences practice. She has a diverse and multidisciplinary background with particular expertise in biomedical and integrated applied sciences, reproductive science, animal health, cell culture and imaging. Her current career focus is in vitro diagnostics, medical devices, alternative animal models, and pharmaceuticals.
For more information about Frost & Sullivan’s global Healthcare & Life Sciences practice, email Jennifer.Carson@frost.com
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