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Can a New Type of Blood Test Identify Macular Degeneration Much Earlier? New Research Says Yes

Cover of the journal Ophthalmology

New research led by the AMD Center of Excellence at Harvard Medical School, the University of Coimbra, Portugal, and Brigham and Women's Hospital has used an emerging field of study, called "metabolomics" (explained below), to test patients' blood and identify blood profiles that are associated with age-related macular degeneration (AMD).

According to study co-author Joan W. Miller, M.D., "With metabolomics, we can identify blood profiles associated with AMD and its severity through laboratory testing. Because the signs and symptoms of early-stage AMD are very subtle, with visual symptoms only becoming apparent at more advanced stages of the disease, identification of [indicators of AMD] in human blood plasma may allow us to better understand the early to intermediate stages of AMD so we may intervene sooner and ultimately provide better care."

From the Journal Ophthalmology

This new macular degeneration blood testing research, titled Human Plasma Metabolomics Study Across All Stages of Age-Related Macular Degeneration Identifies Potential Lipid Biomarkers (explained below), has been published online ahead of print in the September 2017 edition of Ophthalmology, the official journal of the American Academy of Ophthalmology. Ophthalmology publishes original, peer-reviewed research in ophthalmology, including new diagnostic and surgical techniques, the latest drug findings, and results of clinical trials.

The authors are Inês Laíns, MD, MSc; Rachel S. Kelly, PhD; John B. Miller, MD; Rufino Silva, MD, PhD; Demetrios G. Vavvas, MD, PhD; Ivana K. Kim, MD; Joaquim N. Murta, MD, PhD; Jessica Lasky-Su, PhD; Joan W. Miller, MD; and Deeba Husain, MD, who represent the following institutions: Harvard Medical School, Boston, Massachusetts; the University of Coimbra, Portugal; the Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal; and Brigham and Women's Hospital, Boston, Massachusetts.

First, An Explanation of Terms Used in the Research

Here is a brief explanation of some key terms used in this macular degeneration research:

  • Biomarker: A substance in the body that can be measured and whose presence indicates disease, infection, or environmental exposure.
  • Lipid: A substance that is oily to the touch and does not dissolve in water. In the body, lipids store energy and are one of the components of the cells in our bodies.
  • Metabolomics: An emerging field of study that identifies "metabolites," the unique chemical "fingerprints" that specific cell processes leave behind in our bodies.
  • Metabolites: Tiny particles in our bodies that reflect our specific genes and environment, produced during metabolism.
  • Metabolism: The chemical processes that occur within our bodies in order to maintain life.
  • Plasma: The liquid part of blood, which makes up about half the volume of blood. It holds the blood cells in suspension.

About the Macular Degeneration Blood Testing Research

Edited and excerpted from Researchers identify potential biomarkers of age-related macular degeneration, via Medical Xpress:

Patients with any stage of age-related macular degeneration (AMD) carry signs of the disease in their blood that may be found through special laboratory tests, according to a new study. The study describes a new technique known as "metabolomics," which can identify blood profiles associated with AMD and its level of severity. These potential lipid biomarkers in human blood plasma may lead to earlier diagnosis, better [predicting] information, and more precise treatment of patients with AMD, as well as potential new targets for AMD treatment.

"With metabolomics, we can identify blood profiles associated with AMD and its severity through laboratory testing," said co-author Joan W. Miller, M.D. "Because the signs and symptoms of early stage AMD are very subtle, with visual symptoms only becoming apparent at more advanced stages of the disease, identification of biomarkers in human blood plasma may allow us to better understand the early to intermediate stages of AMD so we may intervene sooner, and ultimately provide better care."

"The study used a technique known as metabolomics, or the study of the tiny particles called metabolites, in our body that reflect our genes and environment," explained co-author Ines Lains, M.D. "The metabolome—the set of metabolites present in an individual—is thought to closely represent the true functional state of complex diseases."

"This is why we used it to test 90 blood samples obtained from study participants with all stages of AMD (30 with early-stage disease, 30 with intermediate-stage, and 30 with late-stage) and 30 samples from patients without AMD."

Their [study] revealed 87 metabolites, or small molecules in the blood, that were significantly different between subjects with AMD and those without. Furthermore, the [research] team noted varying characteristics between the blood profiles of each stage of disease. This information has the potential to improve earlier diagnoses for AMD patients, and ultimately, may lead to more treatment options, as well as personalized treatment, for earlier stages of the disease.

More About Age-Related Macular Degeneration

NEI image of how someone with macular degeneration sees: overall blurriness with a blind spot in the center

Seeing the world with AMD

Age-related macular degeneration (AMD) is a gradual, progressive, painless deterioration of the macula, the small sensitive area in the center of the retina that provides clear central vision. Damage to the macula impairs the central (or "detail") vision that helps with essential everyday activities, such as reading, preparing meals, watching television, playing card and board games, and sewing.

AMD is the leading cause of vision loss for people aged 60 and older in the United States. According to the American Academy of Ophthalmology, 10-15 million people have AMD and about 10% of people who are affected have the "wet" type of AMD.

Wet (Neovascular) Macular Degeneration

In wet, or exudative, macular degeneration (AMD), the choroid (a part of the eye containing blood vessels that nourish the retina) begins to sprout abnormal new blood vessels that develop into a cluster under the macula, called choroidal neovascularization (neo = new; vascular = blood vessels).

Because these new blood vessels are abnormal, they tend to break, bleed, and leak fluid under the macula, causing it to lift up and pull away from its base. This damages the fragile photoreceptor cells, which sense and receive light, resulting in a rapid and severe loss of central vision.

About Dry Macular Degeneration

The dry (also called atrophic) type of AMD affects approximately 80-90% of individuals with AMD. Its cause is unknown, it tends to progress more slowly than the wet type, and there is not – as of yet – an approved treatment or cure. "Atrophy" refers to the degeneration of cells in a portion of the body; in this case, the cell degeneration occurs in the retina.

In dry age-related macular degeneration, small white or yellowish deposits, called drusen, form on the retina, in the macula, causing it to deteriorate or degenerate over time.

Photograph of a retina with drusen

A retina with drusen

Drusen are the hallmark of dry AMD. These small yellow deposits beneath the retina are a buildup of waste materials, composed of cholesterol, protein, and fats. Typically, when drusen first form, they do not cause vision loss. However, they are a risk factor for progressing to vision loss.

Risk Factors for Macular Degeneration

The primary risk factors for AMD include the following:

  1. Smoking: Current smokers have a 2-3 times higher risk for developing AMD than do people who never smoked. It's best to avoid second-hand smoke as well.
  2. Sunlight: Ultraviolet (UV) light is not visible to the human eye, but can damage the lens and retina. Blue light waves that make the sky, or any object, appear blue, are visible to the human eye and can also damage the lens and retina. Living Well with Low Vision reports on these lighting issues in Artificial Lighting and the Blue Light Hazard. Avoid UV light and blue/violet light as much as possible by wearing sunglasses with an amber, brown, or orange tint that blocks both blue and UV light.
  3. Uncontrolled hypertension: The National Eye Institute (NEI) reports that persons with hypertension were 1.5 times more likely to develop wet macular degeneration than persons without hypertension. It's important to keep your blood pressure controlled within normal limits.
  4. A diet high in packaged, processed food and low in fresh vegetables: NEI suggests that eating antioxidant-rich foods, such as fresh fruits and dark green leafy vegetables (kale, collard greens, and spinach) may delay the onset or reduce the severity of AMD. Eating at least one serving of fatty fish (salmon, tuna, or trout) per week may also delay the onset or reduce the severity of AMD.
  5. Race: According to NEI, Whites/Caucasians are more likely to have AMD than people of African descent.
  6. Family history: NEI reports that individuals with a parent or sibling with AMD have a 3-4 times higher risk of developing AMD.

You can read more about the full range of AMD risk factors at Risk Factors for Age-Related Macular Degeneration on the VisionAware website.

More Advanced Information About the Study from Ophthalmology

Edited and excerpted from the study Abstract:

Purpose: To characterize the plasma metabolomics profile of patients with age-related macular degeneration (AMD) using mass spectrometry.

Participants: We prospectively recruited participants with a diagnosis of AMD and a control group (greater than 50 years old) without any [retinal] disease. [Editor's note: A prospective study tests the subjects and then follows them into the future.]

Methods: All participants underwent color fundus photography, used for AMD diagnosis and staging, according to the Age-Related Eye Disease Study classification scheme. Fasting blood samples were collected and plasma was analyzed by Metabolon, Inc., using ultrahigh-performance liquid chromatography and high-resolution mass spectrometry. [The research assessed] differences in the metabolomic profiles of AMD patients versus controls, while controlling for potential confounders.

Results: We included 90 participants with AMD (30 with early AMD, 30 with intermediate AMD, and 30 with late AMD) and 30 controls. Using ultrahigh-performance liquid chromatography and mass spectrometry, 878 biochemicals were identified.

[The research analysis] identified 87 metabolites with levels that differed significantly between AMD patients and the controls. Most of these metabolites (82.8%), including the most significant metabolites, belonged to the lipid pathways. [Research analysis] revealed that of the 87 metabolites, 48 (55.2%) also were significantly different across the different stages of AMD.

Conclusions: Participants with AMD have altered plasma metabolomic profiles compared with controls…. These findings have the potential to improve our understanding of AMD pathogenesis, to support the development of plasma-based metabolomics biomarkers of AMD, and to identify novel targets for treatment of this blinding disease.

Additional Information About Macular Degeneration


Topics:
Low Vision
Macular Degeneration
Medical Updates

New Research: Using Virtual Reality Environments to Help with Wayfinding Problems Related to Glaucoma

a view of the retina to check for glaucoma

Glaucoma often is called "the sneak thief of sight" for good reason: Many people are unaware that glaucoma has few symptoms or warning signs in its early stages.

Early treatment for glaucoma can sometimes (but not always) slow the progression of the disease. However, as of yet, there is no cure for glaucoma and its resulting visual field loss, which can interfere with a wide range of everyday activities.

Visual field loss from glaucoma can create problems with moving safely through the environment, including indoor movement and outdoor travel. You can feel unsafe when crossing streets or become lost or disoriented, either inside your home or out in the community.

Now, researchers from the University of California San Diego have investigated the connection between visual field loss from glaucoma and difficulty with wayfinding (explained below) by creating an immersive visual reality environment to determine how people with glaucoma create (or have difficulty creating) a "mental map" to help with these everyday navigation tasks.

In addition to helping with navigation, this "visual mapping" research shows promise for (a) increasing the effectiveness of low vision exams and assessment, (b) teaching important visual skills, such as systematic scanning, and (c) contributing to safer and more efficient orientation and mobility skills.

From Investigative Ophthalmology & Visual Science

This new glaucoma and wayfinding (described below) research, titled Wayfinding and Glaucoma: A Virtual Reality Experiment, has been published as an open-source article in the July 17, 2017 issue of Investigative Ophthalmology & Visual Science, the official journal of the Association for Research in Vision and Ophthalmology (ARVO). ARVO is an international organization that encourages and assists research, training, and publication in vision and ophthalmology, including low vision.

The authors are Fábio B. Daga, Eduardo Macagno, Cory Stevenson, Ahmed Elhosseiny, Alberto Diniz-Filho, Erwin R. Boer, Jürgen Schulze, and Felipe A. Medeiros, from the University of California San Diego, La Jolla, California.

First, An Explanation of Terms Used in the Research

Here is a brief explanation of some key terms used in this glaucoma research:

  • Allocentric: An allocentric frame of reference provides information about the location of an object as it relates to other objects in the environment, independently of the person's own body.
  • Egocentric: An egocentric frame of reference provides information about the location of an object as it relates to the person's own body, such as left/right or up/down.
  • Virtual reality: A computer-generated simulation of a three-dimensional environment that a person can interact with by using special electronic equipment, such as a helmet with a screen inside or gloves fitted with sensors.
  • Wayfinding: The process of making and following a route between a beginning point and a destination.

About the Glaucoma Wayfinding Research

Edited and excerpted from the open-source article Wayfinding and Glaucoma: A Virtual Reality Experiment:

Wayfinding is the process of determining and following a path or route between an origin and a destination. As a process humans use to orient and navigate on foot or with a vehicle, wayfinding is an integral part of people's daily life, occurring in many situations, such as walking inside a home or a building, navigating through a city, or driving across a country.

Wayfinding requires the proper encoding, processing, and retrieval of spatial information, and visual cues are often the main source in perceiving the environment. The purpose of this study was to investigate wayfinding behavior and spatial cognition in patients with glaucoma using a virtual reality (VR) environment, the Virtual Environment Human Navigation Task [called the VEHuNT in this research].

The Subjects

The study included 31 people with glaucoma and 20 subjects with unimpaired vision. In addition to vision and glaucoma testing, the subjects also completed the Montreal Cognitive Assessment Test (MoCA). The MoCA test is a screening tool developed to detect mild cognitive dysfunction.

The Virtual Reality Setup

The subjects sat at a table, wearing polarized glasses to see a 3-D image during testing, and navigated through the virtual environment using a steering wheel and an accelerator pedal. You can view the online virtual reality setup at the ARVO website.

The Virtual Rooms

Virtual Room A contained several visual cues: two large colored walls, two wall cues (paintings), and two floor cues (a chair and a plant, both located off to the side). Because Room A contained many different visual cues, it promoted an allocentric solution to the wayfinding problem and required creating a mental representation of the room, called a cognitive map.

An allocentric frame of reference provides information about the location of an object as it relates to other objects in the environment, independently of the person's own body.

Virtual Room B contained only one visual cue, a chair near the center of the room. Because Room B contained only one central chair placed in a fixed spot, it promoted an egocentric solution to the wayfinding problem and did not require creating a cognitive map.

An egocentric frame of reference provides information about the location of an object as it relates to the person's own body, such as left/right or up/down. You can view the two virtual rooms at the ARVO website.

The Trials

The subjects were instructed to use the steering wheel to "drive" to a clearly indicated location in each one of the two virtual rooms (called the "visible target"), identified by a green cone on the floor. They were instructed to inspect the room and pay attention to the surroundings while "driving" to the target.

Additional trials required the subject to revisit the initial location, but the location was no longer visibly marked (called the "hidden target"). It only reappeared when the subject's driving path intersected with the base of the green cone, which ended the trial.

The Results

In the study, glaucoma subjects performed significantly worse than healthy subjects in wayfinding tasks that promoted allocentric-based spatial reference [those in Room A] to successfully complete the task. This suggests that people with glaucoma may have difficulty building accurate representations of the spatial structure of an environment, in the presence of significant visual field loss.

Times to complete the wayfinding tasks were, on average, over 40% longer for glaucoma compared to healthy subjects for Room A. However, there was no significant difference between the groups for Room B.

Why These Results?

In order to successfully complete the task with the hidden target in Room A, the subject initially had to build an accurate mental representation of the spatial structure of the environment (called a cognitive map). The person would then have to use the cognitive map to guide him or her on how to navigate toward the hidden target.

Cognitive maps help to explain the spatial relationship between things in the world and can recognize places, compute distances and directions, and help a person find the way from where the subject is to where the subject wants to be in complex environments.

There is evidence that loss of peripheral vision may prevent building accurate cognitive maps. In our study, the loss of peripheral field in glaucoma patients may have made it difficult for them to build an accurate cognitive map of the virtual environment. This translated later into difficulties in performing the wayfinding tasks with hidden targets for Room A.

What Does This Mean?

Loss of peripheral vision may impede the ability to perform effective visual searches in the environment and attend to relevant objects. In addition, in the presence of significant peripheral vision loss, the visual information acquired … may not be coherent enough to allow an accurate representation of the location of objects in space relative to each other and the overall environment structure.

Virtual reality environments may represent a useful approach for assessing functional vision in patients and for clinical trials of emerging therapies in ophthalmology.

What Is Glaucoma and Visual Field Loss?

Glaucoma is a group of eye diseases that can lead to blindness by damaging the optic nerve, which transmits information from the eye to the brain, where it is processed and interpreted. The eye continuously produces a fluid, called the aqueous, that must drain from the eye to maintain healthy eye pressure. Glaucoma is particularly dangerous to your vision because there are usually no noticeable initial symptoms or early warning signs.

Glaucoma results in peripheral (or side) vision loss initially, and the effect can be like looking through a tube or into a narrow tunnel. This "tunnel vision" effect makes it difficult to walk without bumping into objects that are off to the side, near the head, or at foot level:

These are examples of peripheral vision loss, or a constricted visual field:

A living room viewed through a constricted visual field

A living room viewed through a constricted visual field.
Source: Making Life More Livable. Used with permission.

Series of four photos demonstrating typical progression of vision loss due to glaucoma. Source: National Eye Institute

The typical progression of vision loss from glaucoma
Source: National Eye Institute

Detecting Glaucoma

Because glaucoma has no obvious initial symptoms, a comprehensive dilated eye exam is critical to detect early glaucoma changes. People who are over 40 should have a dilated eye examination from an ophthalmologist or optometrist at least every two years. African Americans; people who are over 35 and have a family history of glaucoma; and everyone age 60 or older should schedule a comprehensive eye examination every year.

You can learn more about glaucoma detection and treatment at How Can I Detect Glaucoma if There Are No Initial Symptoms?, What Are the Different Treatments for Glaucoma?, and Tips for Taking Glaucoma (and Other) Eye Drops at VisionAware.

More About the Glaucoma Wayfinding Research from Investigative Ophthalmology & Visual Science

Here is more information about the study, excerpted from the article Abstract, with the full open-source article available online:

Purpose: Wayfinding, the process of determining and following a route between an origin and a destination, is an integral part of everyday tasks. The purpose of this study was to investigate the impact of glaucomatous visual field loss on wayfinding behavior using an immersive virtual reality (VR) environment.

Methods: This cross-sectional study included 31 glaucomatous patients and 20 healthy subjects without evidence of overall cognitive impairment. Wayfinding experiments were modeled after the Morris water maze navigation task and conducted in an immersive virtual reality (VR) environment.

[Editor's note: A cross-sectional study analyzes a group of people at one specific point in time, rather than study them over a longer period of time. In contrast, a longitudinal study follows, and gathers information about, the same individuals or group of people over an extended period of time.]

Two rooms were built varying only in the complexity of the visual scene in order to promote allocentric-based (room A, with multiple visual cues) versus egocentric-based (room B, with single visual cue) spatial representations of the environment. Wayfinding tasks in each room consisted of revisiting previously visible targets that subsequently became invisible.

Results: For room A, glaucoma patients spent on average 35.0 seconds to perform the wayfinding task, whereas healthy subjects spent an average of 24.4 seconds. [Note: This result was statistically significant.] For room B, no statistically significant difference was seen on average time to complete the task.

Conclusions: Glaucoma patients performed significantly worse on allocentric-based wayfinding tasks conducted in a virtual reality environment, suggesting visual field loss may affect the construction of spatial cognitive maps relevant to successful wayfinding. Virtual reality environments may represent a useful approach for assessing functional vision endpoints for clinical trials of emerging therapies in ophthalmology.

Additional Information

Published in accordance with the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) License


Topics:
Assistive Technology
Environmental assessment and modification
Getting Around
Glaucoma
In the News
Low Vision
Online Tools
Technology

During Healthy Aging Month, Learn More About Older Adult Eye Health and Low Vision from the National Eye Institute

NEHEP logo

According to the United States National Eye Institute, "Older adults are at higher risk for certain eye diseases and conditions, including age-related macular degeneration, cataract, diabetic eye disease, glaucoma, dry eye, and low vision. Eye diseases often have no early symptoms, but can be detected during a comprehensive dilated eye exam."

"More than 40 million Americans are currently age 65 or older, and this number is expected to grow to more than 88 million by 2050. By that same year, the number of Americans with age-related eye diseases is expected to double, and the number of people living with low vision is projected to triple. Early detection and treatment are key to saving sight."

You can read more statistics about aging and vision loss at Research Navigator: Age is Just a Number, Facts and Figures on Adults with Vision Loss, and Special Report on Aging and Vision Loss at the American Foundation for the Blind website.

In response to these demographic trends, the National Eye Health Education Program (NEHEP), part of the National Eye Institute (NEI), has created the Healthy Aging Month Program, which offers a wide range of English and Spanish resources and media to community and healthcare organizations in order to raise awareness about eye health among older adults.

About the National Eye Institute (NEI) and the National Eye Health Education Program (NEHEP)

The mission of NEI, a part of the National Institutes of Health, is to "conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the blind."

In 1991, NEI established the National Eye Health Education Program (NEHEP) with the aim of increasing awareness among health care professionals and the public of scientifically-based health information that can be applied to preserving sight and preventing blindness.

NEHEP works in partnership with a wide range of public and private organizations that conduct eye health education programs. It also works with organizations that reach populations at higher risk for eye disease and supports collaboration among eye health professionals, healthcare providers, patients, and the public.

The goal of NEHEP is to "ensure that vision is a health priority by translating eye and vision research into public and professional education programs. NEHEP supports collaboration among eye health professionals, healthcare providers, patients, and the public." You can learn more at About NEHEP.

More About the Healthy Aging Month Program

The components of this comprehensive community-based information program include the following:

NEHEP Healthy Aging logo

NEHEP logo text left to right: Articles, Educational Tools and Resources,
Infocards and Infographics, Social Media, Videos

Healthy Aging Month Articles

Healthy Aging Month Articles include ready-to-use articles to share information on dilated eye exams, financial assistance with eye care, and age-related eye diseases and conditions. You can include them in your newsletter, blog, or website; print them to distribute at events; and share them with local media and health journalists.

Educational Tools and Resources

Educational Tools and Resources include:

  • See Well for a Lifetime Toolkit
  • Living with low vision: What you should know booklet
  • Educating older Americans about their aging eyes webinar
  • Vision and aging resources at-a-glance
  • Age-related eye diseases and conditions web page
  • What is a comprehensive dilated eye exam web page
  • Medicare benefit for eye health web page
  • Enfermedades y condiciones de los ojos relacionadas con la edad
  • ¿Qué es un examen completo de los ojos con dilatación de las pupilas?
  • Cómo vivir con Baja Visión: Lo que usted debe saber

Infocards and Infographics

Free downloadable infocards and infographics to share messages on your website or through social media include:

  • What's your risk of eye disease?
  • Smoking does more than take your breath away.
  • The number of people with age-related eye diseases and conditions is on the rise.
  • What Hispanics/Latinos need to know about low vision.
  • Cuide sus ojos y mire hacia el future.
  • El envejecimiento y la salud de los ojos.
  • Lo que los hispanos/latinos deben saber sobre la baja vision.

Social Media

Social Media includes NEHEP social media posts and resources to help you reach older adults about aging and vision loss, including Facebook and Twitter. You can find additional Facebook, twitter, and Pinterest suggestions at NEHEP Vision and Aging: Social Media.

Videos

Healthy Aging Videos include:

  • Dilated eye exam animation
  • Living with low vision: Ruth Lotz
  • Living with low vision: Ruth Margolies
  • Living with low vision: Lawrence Harrison
  • Living with low vision: Stories of hope and independence
  • Living with low vision: Stories of hope and independence [Spanish]
  • Living with low vision: Graciela Castaneda [Spanish]

Additional Information from VisionAware

Visit VisionAware.org to learn more about the different types of eye care professionals, the comprehensive low vision examination, and vision rehabilitation services.

You can use the American Foundation for the Blind Directory of Services to locate low vision and vision rehabilitation services that are available in your state and local area.

More National Eye Institute programs include:


Topics:
Aging
Cataracts
Diabetes and diabetic retinopathy
Glaucoma
Health
In the News
Low Vision
Macular Degeneration

The FDA Officially Cracks Down on Stem Cell Clinics Offering Unproven and Dangerous Treatments

On Monday, August 28, 2017, Scott Gottlieb, M.D., Commissioner of the United States Food and Drug Administration (FDA), announced a crackdown on stem cell clinics offering unproven and potentially dangerous treatments. Commissioner Gottlieb stated that he "will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work."

You can read Dr. Gottlieb's full stem cell statement at Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA's new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine on the FDA website.

According to The Washington Post (subscription required):

In a separate enforcement action, the [FDA] on Monday posted a warning letter issued last week to U.S. Stem Cell of Sunrise, Fla., saying that recent FDA inspections of the clinic found that it was using stem cells derived from fat to purportedly treat illnesses including Parkinson's disease, ALS, and heart disease. The agency said it hasn't approved any of the clinic products for any use.

The clinic in March was the subject of a New England Journal of Medicine article that said that three women with age-related macular degeneration were blinded or had their vision badly impaired after undergoing procedures at the clinic. Stem cells were injected into their [eyes].

You can read the full text of the FDA warning letter to U.S. Stem Cell at Inspections, Compliance, Enforcement, and Criminal Investigations: US Stem Cell Clinic, LLC 8/24/17

More About the U.S. Stem Cell Case

First, it's important to note that even if a clinical trial for eye disease is listed in ClinicalTrials.gov, it does not always mean that the trial has been approved by the United States Food and Drug Administration (FDA) or the National Institutes of Health (NIH). Patients should always consult with their own physicians before seeking to participate in any clinical trial.

Furthermore, if the sponsors of the treatment or trial request payment from the patient to participate, this raises a significant "red flag." Such a situation is called "pay to participate" and raises a number of profound ethical issues, including the lack of equal opportunity for all people to participate.

Photograph of a retina with wet age-related macular degeneration

A retina with wet AMD

The VisionAware blog, in Our Readers Want to Know: What Is the Progress of Stem Cell Research for Eye Disease? Answer: It Has a Very Long Way to Go, has also addressed a number of safety issues surrounding experimental stem cell trials for age-related macular degeneration (AMD), particularly the risks of tumor formation and potential immune rejection.

More recently, VisionAware reported on research conducted by University of Minnesota bioethicist Leigh Turner. Dr. Turner scrutinized the ClinicalTrials.gov website and concluded that "Individuals considering enrolling in [studies listed on ClinicalTrials.gov], advocates for patients, and research subjects, health researchers, and officials at both the NIH and the FDA need to be aware that some businesses are using the ClinicalTrials.gov registry to promote stem cell interventions that study subjects are being charged to receive."

In other words, consumers and their physicians should be aware that some of these businesses have learned to repurpose ClinicalTrials.gov as a marketing and public relations tool to promote their unproven stem cell products and interventions.

Most urgently, the New York Times published a detailed report of three women with AMD who suffered severe, permanent eye damage after stem cells were injected into their eyes in an unproven treatment at U.S. Stem Cell, a private clinic at Sawgrass Medical Center in Sunrise, Florida.

About the Stem Cell/Macular Degeneration Report

The New York Times report is based on Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD, a Brief Report published on March 16, 2017 in the New England Journal of Medicine. The authors are Ajay E. Kuriyan, MD; Thomas A. Albini, MD; Justin H. Townsend, MD; Marianeli Rodriguez, MD, PhD; Hemang K. Pandya, MD; Robert E. Leonard, II, MD; M. Brandon Parrott, MD, PhD; Philip J. Rosenfeld, MD, PhD; Harry W. Flynn, Jr., MD; and Jeffrey L. Goldberg, MD, PhD. The authors represent Bascom Palmer Eye Institute, University of Miami, FL; Center for Sight, Sarasota, FL; Flaum Eye Institute, University of Rochester Medical Center, NY; Dean McGee Eye Institute, University of Oklahoma, Oklahoma City; and Byers Eye Institute, Stanford University, Palo Alto, CA.

First, Some Basic Stem Cell Terminology

Here is a brief explanation of some key terms used in many types of stem cell research:

  • Autologous: Involving one individual as both donor and recipient
  • Immunogenic: Causing, or capable of producing, an immune response.
  • Embryonic stem cells (ESCs): Can form any cell type in the body. However, they are in limited supply, and – due to their origins – have ethical issues attached to their use.
  • Pluripotent: A stem cell that has the power to develop into any type of bodily cell or tissue ("pluri" = many; "potent" = having power)
  • Human pluripotent stem cells (hPSCs): The term includes both human induced pluripotent stem cells (hiPSCs) and human embryonic stem cells (hESCs)
  • Induced pluripotent stem cells (iPSCs): A type of pluripotent stem cell that can be generated or "reprogrammed" directly from adult cells. Induced pluripotent stem cells require viruses to reprogram the cells, which has the potential to cause cancerous tumors.

About the Harmful Stem Cell Treatment

Excerpted from Patients Lose Sight After Stem Cells Are Injected Into Their Eyes, via the New York Times:

Three women suffered severe, permanent eye damage after stem cells were injected into their eyes, in an unproven treatment at a loosely regulated clinic in Florida, doctors reported in an article published Wednesday in the New England Journal of Medicine.

One, 72, went completely blind from the injections, and the others, 78 and 88, lost much of their eyesight. Before the procedure, all had some visual impairment but could see well enough to drive. The cases expose gaps in the ability of government health agencies to protect consumers from unproven treatments offered by entrepreneurs who promote the supposed healing power of stem cells.

The women had macular degeneration, an eye disease that causes vision loss, and they paid $5,000 each to receive stem-cell injections in 2015 at a private clinic in Sunrise, Florida. The clinic was part of a company then called Bioheart, now called U.S. Stem Cell. Staff members there used liposuction to suck fat out of the women's bellies, and then extracted stem cells from the fat to inject into the women's eyes.

Two of the eye patients sued the clinic and settled, but it has faced no other penalties. [The clinic stated that] it no longer treats eyes, but continues to treat five to 20 patients a week for other problems like torn knee cartilage and degenerating spinal discs.

All three women found U.S. Stem Cell because it had listed a study on a government website, clinicaltrials.gov — provided by the National Institutes of Health. Two later told doctors they thought they were participating in government-approved research. But no study ever took place, and the proposed study on the site had no government endorsement. Clinical trials do not need government approval to be listed on the website. Legitimate research rarely, if ever, charges patients to participate, scientists say, so the fees should have been a red flag. But many people do not know that.

The women in Florida suffered detached retinas, in which the thin layer of light-sensing cells that send signals to the optic nerve pulls away from the back of the eye — a condition that usually needs prompt surgery to prevent blindness. Doctors who examined the patients said they suspected that the stem cells had grown onto the retina and then contracted, pulling it off the eyeball.

"The really horrible thing about this is that you would never, nobody practicing good medicine would ever do an experimental procedure on a patient on both eyes on the same day," said Dr. Thomas A. Albini, an author of the article who saw two of the patients, at the Bascom Palmer Eye Institute. Standard practice, he said, is to treat one eye at a time, usually the worse eye first, so that if something goes wrong at least the patient still has one eye left with some vision.

About Clinical Trials

Most clinical trials are designated as Phase 1, 2, or 3, based on the questions the study is seeking to answer:

  • In Phase 1 clinical trials, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe and effective dosage range, and identify possible side effects.
  • In Phase 2 clinical trials, the study drug or treatment is given to a larger group of people to determine if it is effective and to further evaluate its safety.
  • In Phase 3 studies, the study drug or treatment is given to even larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • In Phase 4 studies, after the United States Food and Drug Administration (FDA) has approved the drug, continuing studies will determine additional information, such as the drug's risks, side effects, benefits, and optimal use.

More About the Stem Cell Clinic from the New England Journal of Medicine

Excerpted from the full version of the article, available via subscription only:

We report three cases of vision loss after patients with AMD received bilateral [i.e., in both eyes; in this case, both eyes were injected on the same day] intravitreal injections of autologous adipose tissue–derived stem cells at a stem-cell clinic. ["Autologous adipose tissue-derived" means that staff members at the clinic used liposuction to suck fat out of the women's bellies, and then extracted stem cells from the fat to inject into the women's eyes.] After treatment, in June 2015, the patients were referred to two university-based ophthalmology practices.

Patient 1: A 72-year-old woman with a history of [dry] AMD and a best-corrected Snellen visual acuity of 20/60 in the right eye and 20/30 in the left eye underwent bilateral [i.e., both eyes] injection [into the eyes] of autologous adipose tissue–derived stem cells for the treatment of [dry] AMD.

The patient underwent the procedure at a stem-cell clinic that had an institutional review board–approved research trial listed on ClinicalTrials.gov at the time; however, the written information provided to the patient did not mention participation in a clinical trial, review or approval by an institutional review board, or an association with a trial listed on ClinicalTrials.gov.

The patient reported that she had found the stem-cell clinic through its listing on ClinicalTrials.gov. She also reported that she was under the impression that she was participating in a clinical trial and that she had met the criteria of the trial. She paid $5,000 for the bilateral [i.e., both eyes] procedure. The consent form indicated the risk of blindness. The patient presented to the Bascom Palmer Eye Institute in Miami three days after the intravitreal injection.

Patient 2: [Wet] AMD was diagnosed in a 78-year-old woman with a best-corrected Snellen visual acuity of 20/50 in the right eye and 20/100 in the left eye after she received bilateral injections of anti–vascular endothelial growth factor (VEGF) drugs in both eyes over the course of two years and before she received bilateral intravitreal injections [i.e., injected into both eyes] of autologous adipose tissue–derived stem cells at the same stem-cell clinic.

Like Patient 1, she was aware of the clinical trial posted on ClinicalTrials.gov by the stem-cell clinic. She also paid $5,000 for the same procedure that Patient 1 had undergone. Approximately two days after Patient 2 received bilateral intravitreal injections, she presented to both the Bascom Palmer Eye Institute and to the Center for Sight in Sarasota, Florida.

Patient 3: An 88-year-old woman with a visual acuity of 20/40 in the right eye and 20/200 in the left eye had a history of [dry] AMD with bilateral geographic atrophy and a retinal tear treated with cryopexy in the left eye 30 years before she received bilateral intravitreal stem-cell injections, as described in Patients 1 and 2. Patient 3 received injections at the same stem-cell clinic for $5,000. Patient 3 presented one week after the procedure to the Dean McGee Eye Institute, Oklahoma City.

Discussion: Although numerous stem-cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem-cell clinics are treating patients with little oversight and with no proof of efficacy. A distinction has been made between clinical studies of stem-cell therapies that are founded on solid preclinical research with strong scientific design and programs that lack preclinical research justification. These programs are often funded by patients at nonacademic centers, and they may not receive FDA oversight if these procedures are performed without the filing of an investigational new drug application with the FDA, which requires extensive safety data.

At least one of the patients thought the procedure was performed within the context of a clinical trial. However, the consent forms signed by all three patients do not mention a clinical trial. The patients paid for a procedure that had never been studied in a clinical trial, lacked sufficient safety data, and was performed in both eyes on the same day. Experimental bilateral [eye] injections are both atypical and unsafe.

The need for oversight of such clinics and for the education of patients by physicians and regulatory bodies is paramount to protecting patients while advancing proper research and innovation.

A Final Word from the FDA

According to The Washington Post (subscription required):

[FDA Commissioner] Gottlieb, in a separate policy statement about stem cell therapies, said that the emerging field of cell-based and so-called regenerative medicine holds "significant promise for transformative and potentially curative treatments" for serious illnesses but that "a small number of unscrupulous actors" is putting the field at risk. He said he is launching a new working group at the FDA "to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health."

To Our Readers

Please don't be enticed by unproven treatments, miracle cures, and faulty science. Always consult with your own physician before you enter any kind of clinical trial. Be an informed, careful, and wise consumer. Read the latest American Academy of Ophthalmology Statement on Stem Cell Therapy for Treating Eye Disease.

Additional Information


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Clinical Trials
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In the News
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Medical Updates

A New Eye Health Awareness Program from the National Eye Institute Designed Specifically for African American Consumers: Write the Vision

NEHEP logo

A growing body of diabetes, vision, and health care research indicates that significant disparities in the quality and equity of eye care exist throughout the United States, specifically within African American patient communities.

This research includes evaluating the disparities in screening rates for diabetic retinopathy among minority patients, examining the rates of vision loss of African-American patients with diabetes, and determining the rates of follow-up eye care among African-American persons with diabetic eye disease.

Now, in response to this developing body of evidence and knowledge, the National Eye Health Education Program (NEHEP), part of the National Eye Institute, (NEI) has released Write the Vision: Make Your Plan to Protect Your Sight, an eye health awareness initiative designed specifically for African Americans. Write the Vision offers monthly resources to a wide range of organizations, enabling them to promote healthy vision and help prevent vision loss and blindness in the communities they serve.

According to NEHEP, "It is important for African Americans to be aware of their eye health because they are at higher risk for certain eye diseases that, if left untreated, can cause vision loss, even blindness. The good news is that vision loss can often be prevented. Visiting an eye care professional for a comprehensive dilated eye exam is the only way to really be sure your eyes are healthy."

About the National Eye Institute (NEI) and the National Eye Health Education Program (NEHEP)

The mission of NEI, a part of the National Institutes of Health, is to "conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the blind."

In 1991, NEI established the National Eye Health Education Program (NEHEP) with the aim of increasing awareness among health care professionals and the public of scientifically-based health information that can be applied to preserving sight and preventing blindness.

NEHEP works in partnership with a wide range of public and private organizations that conduct eye health education programs. It also works with organizations that reach populations at higher risk for eye disease and supports collaboration among eye health professionals, healthcare providers, patients, and the public.

The goal of NEHEP is to "ensure that vision is a health priority by translating eye and vision research into public and professional education programs. NEHEP supports collaboration among eye health professionals, healthcare providers, patients, and the public." You can learn more at About NEHEP.

More About the Write the Vision: Make Your Plan to Protect Your Sight Initiative

NEHEP protect your sight logo

NEHEP logo text: Help raise awareness of eye health among African Americans.

The components of this comprehensive community-based information program include the following:

Eye Diseases Among African Americans

Eye Diseases Among African Americans includes information on the most common eye diseases and conditions that affect African Americans, including cataract, diabetic eye disease, glaucoma, and low vision.

According to NEHEP, "Many of these diseases and conditions do not have noticeable symptoms in their early stages, but they can be detected through a comprehensive dilated eye exam. Treatment is most effective when an eye disease is diagnosed early. African Americans have some of the highest rates of vision impairment and blindness due to eye disease. Unfortunately, too many African Americans do not get regular, comprehensive dilated eye exams that could help save their sight."

NEHEP eye statistics logo

NEHEP logo text (above): Approximately 828,000 African Americans have diabetic retinopathy and this number is expected to exceed one million by 2030. African Americans are at higher risk for glaucoma at a much younger age (40 years) than other populations (60 years). Approximately 188,000 African Americans have low vision and this number is expected to reach 366,000 by 2030.

Resources by Month

Resources by Month offers a free monthly set of materials, featuring a unique message that promotes healthy vision using a seasonal theme. Monthly materials include articles, slides, fact sheets, or infographics that users can incorporate into their existing programs and community outreach.

Resources by Topic

Resources by Topic includes vision materials that organizations can order, print, and download to support their educational efforts. NEI's Diabetic Eye Disease, Glaucoma, Healthy Vision, Low Vision, and Vision and Aging materials can help promote awareness for a variety of age groups throughout the year.

Resources by Type

Resources by Type includes a variety of educational sources to order, print, and download, including articles, social media posts, infocards, and infographics for health fairs and community events.

Watch, Listen, and Learn

Watch, Listen, and Learn provides a collection of NEI educational videos to help people learn about diabetic eye disease, comprehensive dilated eye exams, and to promote eye health messages. Topic areas include cataract; common vision problems; comprehensive dilated eye exam animation; living with low vision; patient testimonials; detecting glaucoma; and glaucoma animation.

Social Media

Social Media includes NEHEP social media posts and resources to help reach African American consumers about eye disease, including Facebook, Twitter, and YouTube. Use the hashtag #WriteTheVision.

Additional Information from VisionAware

Visit VisionAware.org to learn more about the different types of eye care professionals, the comprehensive low vision examination, and vision rehabilitation services.

You can use the American Foundation for the Blind Directory of Services to locate low vision and vision rehabilitation services that are available in your state and local area.


Topics:
Cataracts
Diabetes and diabetic retinopathy
Education
Glaucoma
Health
Low Vision
Online Tools

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