Tag: ophthalmology

Bioethics Blogs

Blinded by the Promise of Stem Cell Treatments

Alan F. Cruess cautions against the use of unproven stem cell ‘treatments.’

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Recently, many of you may have read about three patients who are blind after receiving stem cell ‘treatments.’  The patients were ‘treated’ at a Florida clinic for age-related macular degeneration. This common eye condition is the leading cause of vision loss among people over the age of 50. The clinic harvested stem cells from the patients using liposuction and then injected these stem cells into their eyes. Again, these three patients, are now all blind as a result of this unproven ‘treatment.’

There are two types of age-related macular degeneration: ‘wet’ and ‘dry.’ In recent years, treatment of wet macular degeneration has been transformed by new drugs which can be very effective if they are applied early. Meanwhile, treatment of the more common dry macular degeneration remains elusive. As such, patients with dry macular degeneration may be desperate to prevent and reverse blindness and willing to try emerging regenerative therapies.

Some experimental stem cells treatments to prevent blindness are promising, and they are being studied worldwide in laboratories and highly regulated clinical trial settings. In these settings, the safety and efficacy of experimental treatments can be closely monitored. Yet, the safety and efficacy should be called into question when these so-called ‘treatments’ are marketed outside of the research context. This was the case at the Florida clinic.

Before subjecting oneself or a loved one to any new ‘treatment’ with stem cells patients should be informed about the risks and potential benefits of the proposed treatment.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Regenerative Medicine: The Promise and Peril

Caption: Scanning electron micrograph of iPSC-derived retinal pigment epithelial cells growing on a nanofiber scaffold (blue).
Credit: Sheldon Miller, Arvydas Maminishkis, Robert Fariss, and Kapil Bharti, National Eye Institute/NIH

Stem cells derived from a person’s own body have the potential to replace tissue damaged by a wide array of diseases. Now, two reports published in the New England Journal of Medicine highlight the promise—and the peril—of this rapidly advancing area of regenerative medicine. Both groups took aim at the same disorder: age-related macular degeneration (AMD), a common, progressive form of vision loss. Unfortunately for several patients, the results couldn’t have been more different.

In the first case, researchers in Japan took cells from the skin of a female volunteer with AMD and used them to create induced pluripotent stem cells (iPSCs) in the lab. Those iPSCs were coaxed into differentiating into cells that closely resemble those found near the macula, a tiny area in the center of the eye’s retina that is damaged in AMD. The lab-grown tissue, made of retinal pigment epithelial cells, was then transplanted into one of the woman’s eyes. While there was hope that there might be actual visual improvement, the main goal of this first in human clinical research project was to assess safety. The patient’s vision remained stable in the treated eye, no adverse events occurred, and the transplanted cells remained viable for more than a year.

Exciting stuff, but, as the second report shows, it is imperative that all human tests of regenerative approaches be designed and carried out with the utmost care and scientific rigor.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Embryonic stem cells to treat severe eye diseases?

El Mundo issue, wich we  consider ethically questionable beacause the results of uncompleted clinical trials are assumed to be reliable, since this can create unfounded expectations

Introduction

On 15 October 2014, Spanish newspaper El Mundo published a report, with a prominent editorial, discussing a recent article published online in medical journal The Lancet (doi.org/10.1016/S0140-6736(14)61376.3) on the same date.

The facts

The article published in The Lancet described how retinal epithelium cells were obtained using embryonic stem cells (eSC), which were then transplanted into nine patients with Stargardt’s macular dystrophy and a further nine patients with age-related macular degeneration (AMD). The patients were followed-up for 22 months with the relevant ophthalmological examinations. The trials were recorded on the Clinical Trials.gov website: trial number NET0134500 for Stargardt’s dystrophy patients, and NCT01344993 for AMD patients.

This was a phase 1/2 clinical trial, so its aim was to evaluate the safety and tolerability of treatment, not the clinical results. There was no evidence of adverse proliferation or rejection. The adverse effects found were attributed to the vitreoretinal surgery and immunosuppressive therapy. Although the aim of the study was not to assess the clinical effects, the investigators reported that vision was recovered in ten patients (in the treated eye), remained unchanged in seven, and decreased in one, while the vision in the patients’ untreated eye remained similar to the baseline values.

The authors stated that this was the first time that such an experiment had been conducted, and that it had been shown to be safe, with survival of the cell implant and possible biological activity of the transplanted stem cell progeny.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Two Cheers for Choosing Wisely

The Choosing Wisely campaign is one of the most exciting experiments in health care in quite a while. If it lives up to its potential, Choosing Wisely could prevent some of the harm caused by unnecessary tests and treatments, while helping to bring down medical costs. But the real challenge to the campaign is whether it actually “empowers” consumers to do anything other than hurl themselves at a brick wall.

Choosing Wisely, begun in 2012, challenges medical specialties to create lists of the five most commonly misused and overprescribed interventions. Today there are more than 50 lists. Consumers Union is helping the campaign to bring its message to consumers in user-friendly form. And, indeed, the campaign is doing a wonderful job. The website (choosingwisely.org) has not only the lists, but terrific back-up resources to help laypeople understand the reasoning behind the lists. There are explanations about everything from why to avoid feeding tubes for Alzheimer’s patients, to how often one needs a colonoscopy.

True, Choosing Wisely is a work in progress. I wish dentists and orthodontists would sign on. And the current lists have been criticized for focusing on low-ticket items or on interventions performed by other specialties. Number one on the list from the American Academy of Ophthalmology, for example, is routine electrocardiograms (EKGs) before cataract surgery, a relatively low cost intervention provided commonly by primary care physicians.

The rationale for the campaign is to “educate and empower” consumers (whom they insist on calling “patients”) and to “promote conversations between providers and patients.” The goal is to help consumers choose care that is evidence-based and not harmful.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.