For Part I of this blog, I will highlight a new discovery where scientists have now been able to create cloned stem cells and I will review two ethical debates that were central to earlier discourse surrounding stem cell research: (1) the moral status of human embryos and (2) the potential physical and social harms to women as egg providers.

So finally research cloning (a.k.a. therapeutic cloning) has been achieved! The technique is called somatic cell nuclear transfer (SCNT) and now has been used to derive human embryonic stem cells (hESCs) (Tachibana et al., Cell 2013). Performing SCNT using human oocytes is an astonishing accomplishment and has significant ethical and clinical implications.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

Several scholars claim that hyping different biotechnologies will lead to a loss of public trust which in turn will result in a loss of support for science. This has been discussed in the context of genomics research, gene therapy, stem cell research, biobanking, neuroimaging research, and nanotechnology. The problem most articulate is that hype in terms of promising medical benefits to the public will generate an expectation by the public and when such expectations are unmet, the public’s support for science will wane. Certainly there is social science evidence to support that (a) hype over many biotechnologies is present in the popular media and (b) several actors are involved in hyping science including scientists, media, politicians, and others. And while the idea that hype and unmet expectations could result in a loss of public trust and support for science seems logical and to some degree intuitive, I think the reality is that the relationship between hype, public trust, and the loss of support for science is quite complex. It is also complicated to measure empirically and to date, there is no study I have come across that demonstrates this relationship. In fact, the one study evaluating the public and donor’s perceptions on hype and stem cell research actually shows that people “aren’t taken in by media hype.”

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

The Dickey-Wicker Amendment (DWA) was passed in 1996 and prevents federal funding of research that destroys embryos. This congressional prohibition defines a human embryo as “any organism not protected as a human subject” that was “derived by fertilization, parthenogenesis, or any other means from one or more human gametes.” While there has been much debate in the bioethics and popular press media about the ethics of embryo research, what has been almost entirely overlooked is the ethics of parthenote research.

The DWA conflates embryos and parthenotes even though there are important scientific and ethical differences between them. Parthenotes are cells derived by parthenogenesis, the process in which eggs become activated to begin dividing without fertilization. Because there is no sperm involvement, parthenotes contain genetic material from only one source (i.e. the egg). In contrast, embryos are created through fertilization and contain genetic material from two genetically dissimilar cells (i.e. egg and sperm). Another important difference is that while embryos can result in a live birth baby, human parthenotes cannot. Human parthenotes, whether they come into existence naturally or in a lab, die in the early stages of development. Scientists can create human parthenotes in the lab by activating eggs through chemical stimuli that mimic fertilization, but studies in other mammals indicate that, without the required genetic imprinting, further development is ruled out.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

Last month, I discussed a research integrity case making international headlines of an iPS cell study conducted by a researcher Hisashi Moriguchi who had allegedly falsified or fabricated data, provided false institutional affiliation, plagiarized work, and had questionable publication practices. In this post, I want to outline a few of the lessons we can learn from this case.

I think Péter Kakuk said it best when he wrote that the Hwang cloning scandal “might shed light on the often neglected benefits of the 'social control of science'".  As a trained scientist, I can say that I used to believe that many of the safeguards felt more like impediments to research progress. As a bioethics researcher, I still feel there are kinks in the system of ethical oversight and there is evidence to support this view. However, I also believe that the ethical safeguards are in place to promote the responsible conduct of research and ensure that research is performed by upholding the utmost standards of integrity. In every issue of Nature or Science there is some report of research misconduct or misbehavior. There have been studies done in the US and many other nations about the frequency of misconduct. Yet despite such reports, I feel many scientists still believe there are too many research hurdles only to catch a few bad apples. This view needs to shift.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

This blog will have two parts. In this first entry, I present will discuss a recent case of stem cell fraud and the subsequent blog entry will discuss possible lessons to learn appearing next month.

The tale begins when Woo-Suk Hwang, a once celebrated hero of South Korea, claimed to have made the first, patient-specific human embryonic stem cell (hES) line through a technique called somatic cell nuclear transfer (commonly referred to as research or therapeutic cloning). This study was soon after proven to be fraudulent. Not to get into too many details, but this technique requires obtaining ova from women providers, enucleating its genetic material, and placing the nucleus from a somatic cell and parthenogenically activating the egg. This initiates embryonic development and at about day 3-4 of development (where the embryo is at the blastocyst stage), hES cells can be isolated from the inner cell mass of blastocysts. This incredible feat in stem cell research was published in Science in 2004 and another study in 2005. In 2006, Hwang was discredited for fabricating results and after an investigation, he was convicted for embezzlement and bioethical allegations. He embezzled approximately 830 million won (US $700,000) of government funds and apparently used 2,200 eggs obtained from his female postgraduate students and junior researchers. All wasted!

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

Stem cell tourism is a pejorative term used to describe clinics that offer under or untested stem cell interventions to patients with debilitating diseases. This includes Parkinson’s disease, multiple sclerosis, ALS, blindness, cancer, cerebral palsy, spinal cord injury and many others. We used to think about stem cell tourism as potential patients traveling to clinics from countries like the US, UK, Canada and Australia to countries with lax regulations, but this simply is not the case anymore. There are several clinics within the US that offer under or untested stem cell interventions, some of which are being challenged by the FDA. The stem cell tourism market is an internet-based, direct-to-consumer market. There is a lack of scientific evidence and clinical research supporting the claims made by clinics in regards to the efficacy of these so-called “treatments”. The evidence sold to patients are testimonials by other patients saying how great they feel and how it has helped them and given hope. This is further fueled as some public perception studies indicate that several patients are frustrated and seem to distrust their domestic healthcare, research and regulatory system. So why offer these therapies? Well for starters, stem cell providers could make a ton of money (ranging from $5,000 to $30,000), especially because sometimes patients require repeated treatments. The market has more recently attracted celebrity types including several high profile athletes, Hollywood stars, and even a US State Governor.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

On July 11, Wills Eye Institute ophthalmologist Carl Regillo delicately placed 100,000 cells beneath the retina of 52-year-old Maurie Hill’s left eye. She was rapidly losing her vision due to Stargardt disease, an inherited macular dystrophy similar to the much more common dry age-related macular degeneration (AMD).

Maurie’s disease was far along, the normally lush forests of photoreceptor cells in the central macula area severely depleted, especially the cones that provide color vision. Would the introduced cells nestle among the ragged remnants of her retinal pigment epithelium (RPE) and take over, restoring the strangled energy supply to her remaining photoreceptors? They should, for the cells placed in Maurie’s eye weren’t ordinary cells. They were derived from human embryonic stem cells (hESCs).

I’ve waited 15 years to see human embryonic stem cells, or their “daughter” cells, make their way through clinical trials. And thanks to Maurie’s sharing her story, I’m witnessing translational medicine.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

On Sunday morning, July 21, I faced a room of people from families with Leber congenital amaurosis (LCA), an inherited blindness caused by mutations in any of at least 18 genes. It was the final session of the Foundation for Retinal Research’s bi-annual LCA family conference, and I was there to discuss the history of gene therapy. But I zapped through that quickly, because the future is much more intriguing.

The excitement pervading the room that day was palpable, following a day of scientific updates, and not only because those with young children were soon to visit Sesame World and the sights of Philadelphia.

Exome sequencing identified the rare mutation that causes Gavin Stevens’ hereditary blindness (Leber congenital amaurosis, or LCA). (Photo: Jennifer Stevens)

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

Hannah Sames, here with her dog Ginger, awaits gene therapy. (photo: Dr. Wendy Josephs)

The pharmaceutical industry rightly calls the stage in drug development between basic research and clinical trials the “Valley of Death.” This is when a potential treatment that’s worked in mice, monkeys, and the like catapults to a phase 1 clinical trial to assess safety. It’s rare.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

We humans might not be able to regrow a leg, as can a cockroach or salamander, or regenerate a missing half, like a flatworm, but our organs can replenish themselves – thanks to stem cells. Two new reports about opposite ends of the respiratory system may pave the way for replacement breathing parts.

A 36-year-old grad student from Eritrea was facing certain death from a golf-ball-sized tumor obstructing his trachea and sending tentacles towards his bronchi, the paired tubes that lead into the lungs. He was saved with a “tailored bioartificial nanocomposite” replacement trachea seeded with his own bone marrow stem cells, reported in The Lancet.

Cancer of the trachea is often inoperable and rapidly fatal because even a ventilator can’t push air into the lungs. But the combination of a glass-like tube standing in for the natural cartilage plus the patient’s own stem cells lets biology take over. Extracellular matrix spread over the tube, new capillaries sprouted, and a coat of epithelium knitted itself. The man is now well and lived to see the birth of his child, thanks to the tissue engineers at the Karolinska Institute and the University of Iceland.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.