StemCells, Inc. Announces First Transplant of Neural Stem Cells Into Patient in Clinical Trial for Dry Age-Related Macular Degeneration

Source: StemCells, Inc.
Date: October 4, 2012

 Summary:

 NEWARK, Calif. -- StemCells, Inc. today announced that the first patient in its Phase I/II clinical trial in dry age-related macular degeneration (AMD) has been enrolled and transplanted. The trial is designed to evaluate the safety and preliminary efficacy of the Company's proprietary HuCNS-SC® product candidate (purified human neural stem cells) as a treatment for dry AMD, and the patient was transplanted with the cells yesterday at the Retina Foundation of the Southwest (RFSW) in Dallas, Texas, one of the leading independent vision research centers in the United States. AMD afflicts approximately 30 million people worldwide and is the leading cause of vision loss and blindness in people over 55 years of age.

Scientists Produce Eye Structures from Human Blood-Derived Stem Cells

Source: University of Wisconsin-Madison
Date: March 13, 2012

Summary:

For the first time, scientists at the University of Wisconsin-Madison have made early retina structures containing proliferating neuroretinal progenitor cells using induced pluripotent stem (iPS) cells derived from human blood.

And in another advance, the retina structures showed the capacity to form layers of cells - as the retina does in normal human development - and these cells possessed the machinery that could allow them to communicate information. (Light-sensitive photoreceptor cells in the retina along the back wall of the eye produce impulses that are ultimately transmitted through the optic nerve and then to the brain, allowing you to see.) Put together, these findings suggest that it is possible to assemble human retinal cells into more complex retinal tissues, all starting from a routine patient blood sample.

Many applications of laboratory-built human retinal tissues can be envisioned, including using them to test drugs and study degenerative diseases of the retina such as retinitis pigmentosa, a prominent cause of blindness in children and young adults. One day, it may also be possible replace multiple layers of the retina in order to help patients with more widespread retinal damage.

The study is published in the journal Investigative Ophthalmology & Visual Science.

StemCells, Inc. Receives FDA Authorization for Age-Related Macular Degeneration Clinical Trial

Source: StemCells, Inc.
Date: February 2, 2012

Summary:

NEWARK, Calif. -- StemCells, Inc. today announced that the U.S. Food and Drug Administration (FDA) has authorized the initiation of a Phase I/II clinical trial of the Company's proprietary HuCNS-SC® product candidate (purified human neural stem cells) in dry age-related macular degeneration (AMD), the most common form of AMD. AMD is the leading cause of vision loss and blindness in people over 55 years of age, and approximately 30 million people worldwide are afflicted with the disease. There are no approved treatments for dry AMD.

The Phase I/II trial will evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. The trial will be an open-label, dose-escalation study, and is expected to enroll a total of 16 patients. The HuCNS-SC cells will be administered by a single injection into the space beneath the retina. Patients' vision will be evaluated using conventional methods of ophthalmological assessment at predetermined intervals over a one-year period. Patients will then be followed for an additional four years in a separate observational study.

Preclinical data submitted as part of the Company's Investigative New Drug application demonstrated that HuCNS-SC cells protect host photoreceptors and preserve vision in a well-established animal model of retinal disease that is relevant to dry AMD. HuCNS-SC transplants significantly protect against the degeneration of photoreceptors, the key cells of the eye involved in vision. Moreover, the number of cone photoreceptors, which are responsible for central vision, remain constant over an extended period, consistent with the sustained visual acuity and light sensitivity observed. In humans, degeneration of the cone photoreceptors account for the unique pattern of visual loss in dry AMD. A summary of the Company's preclinical data was published in the February issue of the international peer-reviewed European Journal of Neuroscience.

Stem Cells Can Repair a Damaged Cornea

Source: University of Gothenburg
Date: February 1, 2012

Summary:

A new cornea may be the only way to prevent a patient going blind -- but there is a shortage of donated corneas and the queue for transplantation is long. Scientists at the Sahlgrenska Academy have for the first time successfully cultivated stem cells on human corneas, which may in the long term remove the need for donators. Their study is now published in the journal Acta Ophthalmologica, and shows how human stem cells can be caused to develop into what are known as "epithelial cells" after 16 days' culture in the laboratory and a further 6 days' culture on a cornea.

Scientists are hailing the discovery as the first step towards being able to use stem cells to treat damaged corneas. They also note that if a routine method is established to carry out the procedure, the availability of material for patients who need a new cornea will be essentially unlimited. Both the surgical procedures and the aftercare will also become much more simple

StemCells, Inc. Announces Publication of Preclinical Data Demonstrating Its Human Neural Stem Cells Preserve Vision

Source: StemCells, Inc.
Date: January 30, 2012

Summary:

StemCells, Inc. today announced the publication of preclinical data demonstrating that its proprietary HuCNS-SC® cells (purified human neural stem cells) protect host photoreceptors and preserve vision in an animal model of retinal disease. The preclinical results are highly relevant to human disorders of vision loss, the most notable of which is dry age-related macular degeneration (AMD). The study and will be featured as the cover article in the February issue of the international peer-reviewed European Journal of Neuroscience. The results of the study show that photoreceptors, the key cells of the eye involved in vision, were protected from degeneration following transplantation of HuCNS-SC cells into the Royal College of Surgeons (RCS) rat.

COVERAGE SUMMARY: ACT Publishes First Report of Embryonic Stem Cell (ESC)-Derived Cells Transplanted Into Patients

Below is a summary of media coverage of the announcement by Advanced Cell Technology Inc. that Phase 1/2 clinical data published in The Lancet as an early online publication demonstrate the safety of ACT’s human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells for the treatment of Stargardt’s macular dystrophy (SMD) and dry age-related macular degeneration (dry AMD):

Washington Post, January 23, 2012: "Embryonic stem cells appear to restore some vision to legally blind patient":

For the first time, an experimental treatment made from human embryonic stem cells has shown evidence of helping someone, partially restoring sight to two people suffering from slowly progressing forms of blindness. Although the purpose of the experiment was to test the safety of stem cells injected into the eye, both patients “had measurable improvement in their vision that persisted through the duration of the study,” said Robert Lanza, chief scientific officer at Advanced Cell Technology, the Massachusetts biotech company that sponsored the closely watched experiment.

NPR, All Things Considered, January 23, 2012, 11:46 am EST: "First Hints That Stem Cells Can Help Patients Get Better":

Two women losing their sight to progressive forms of blindness may have regained some vision while participating in an experiment testing a treatment made from human embryonic stem cells, researchers reported today. The report marks the first time that scientists have produced direct evidence that human embryonic stem cells may have helped a patient. The cells had only previously been tested in the laboratory or in animals.

Reuters, January 23, 2012 6:32 pm EST: "First patients shown to improve with embryonic stem cells":

Before treatment, the 51-year-old graphic artist was legally blind, unable to read a single letter on a standard eye chart. She has suffered from Stargardt's disease, the most common form of macular degeneration in young patients, since she was a teenager, and it was getting progressively worse.

A second patient, aged 78, suffered from dry macular degeneration - the leading cause of blindness in the elderly -and could not even see well enough to go shopping. But after being treated with stem cells from a donated human embryo, both women have improved dramatically, researchers said on Monday. Stem cells are master cells that can differentiate into any of the 200 kinds of cells in the human body. Their results are the first-ever report of the medical use of stem cells taken from human embryos, making them crucial barometers of whether the controversial technique will ever find widespread therapeutic uses.

Associated Press, January 23, 2012: "Study: Stem cells may aid vision in blind people":

Two legally blind women appeared to gain some vision after receiving an experimental treatment using embryonic stem cells, scientists reported Monday. While embryonic stem cells were first isolated more than a decade ago, most of the research has been done in lab animals. The new results come from the first tests in humans for a vision problem. Researchers caution the work is still very preliminary.

USA Today, January 23, 2012: "Stem cells offer first glimpse of blindness treatment":

In the first published results of a therapy using human embryonic stem cells, the controversial treatment slightly improved the vision of two legally blind patients, researchers reported Monday. Intended as a safety test, the experiment reported in the journal The Lancet follows more than a decade of debate over human embryonic stem cells. Seen as a potential treatment of diseases such as diabetes and blindness, the therapy has also drawn criticism from conservative groups that have decried the cells' origins — removed from early human embryos that are destroyed in the process, and then grown into colonies for research.

New York Times, January 23, 2012: "Stem Cell Treatment for Eye Diseases Shows Promise":

A treatment for eye diseases that is derived from human embryonic stem cells might have improved the vision of two patients, bolstering the beleaguered field, researchers reported Monday. The report, published online in the medical journal The Lancet, is the first to describe the effect on patients of a therapy involving human embryonic stem cells.

Daily Telegraph, 23 January 2012 4:18PM GMT: "Human stem cell therapy works in blind patients in first trial":

Scientists have improved the sight of two people who were almost blind by injecting their eyes with stem cells from embryos. Marcus Hilton is the first person in Europe to take part in stem cell trial for a rare eye disease. The two women, both registered as blind, saw their vision improve in a matter of weeks after being given the embryo-derived cells in the US safety trial. The breakthrough holds out the hope of a cure in the future for age-related macular degeneration, which currently affects some 500,000 people in Britain. The results, published this week in The Lancet, provide a major boost for the field of stem cell research.

Toronto Star, January 23, 2012: "Can stem cells cure blindness?":

Two women who are legally blind appear to have some vision restored after being treated with stem cells from a donated human embryo, scientists reported Monday. One patient, a 51-year-old graphic artist with Stargardt’s macular dystrophy, the most common form of macular degeneration in young patients, reported seeing a greater range of colours and felt comfortable riding a bike after the treatment. More crucially, the scientists reported no adverse affects or safety concerns in either woman four months after the experimental therapy. The study is the first-ever to report on the medical use of human embryonic stem cells in patients for the treatment of any disease.

HealthDay News, January 23, 2012: "Small Stem Cell Study Claims Early Success in Treating Eye Disease: Two patients appeared to benefit from therapy for macular degeneration":

Using human embryonic stem cells to treat the eye disease macular degeneration appears to be safe and leads to some vision improvement, a small, early-stage study found. The study included one elderly patient and one younger adult patient with different types of macular degeneration that had led to severe vision loss.

After four months, the embryonic stem cell transplants seemed safe and both patients had some improvement in vision, the U.S. researchers said. The study, published online Jan. 23 in The Lancet, is the first report of the use of human embryonic stem cells (hESC) in humans for any purpose, the researchers said in a news release from the journal.

ACT Publishes First Report of Embryonic Stem Cell (ESC)-Derived Cells Transplanted Into Patients

Source: Advanced Cell Technology, Inc.
Date: January 23, 2012

Summary:

MARLBOROUGH, Mass. —– Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that Phase 1/2 clinical data published in The Lancet as an early online publication demonstrate the safety of ACT’s human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells for the treatment of Stargardt’s macular dystrophy (SMD) and dry age-related macular degeneration (dry AMD). Results were reported for two patients, the first in each of the Phase 1/2 clinical trials. In addition to showing no adverse safety issues, structural evidence confirmed that the hESC-derived cells survived and continued to persist during the study period reported. Both patients had measurable improvements in their vision that persisted for more than four months.

At four months following treatment, no hyperproliferation, tumorigenicity, ectopic tissue formation, or apparent rejection were observed in either patient at any time. Detailed clinical and diagnostic laboratory assessments were performed at multiple post-transplantation evaluations. Abnormal growth (or tumor formation) would be considered a significant safety concern for stem-cell based therapies, in particular those derived from hESCs due to their pluripotency; it is therefore critical to control the differentiation of hESCs. Results reported indicate that stem cell differentiation was well controlled in these patients. No adverse safety signals were detected.

ACT Receives Approval for First Human Embryonic Stem Cell Trial in Europe

Source: Advanced Cell Technology, Inc.
Date: September 22, 2011

Summary:

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that it has received clearance from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to begin treating patients as part of a Phase 1/2 clinical trial for Stargardt’s Macular Dystrophy (SMD) using retinal pigment epithelium (RPE) derived from human embryonic stem cells (hESCs). ACT received similar approval from the the Gene Therapy Advisory Committee (GTAC), which has responsibility for the ethical oversight of proposals to conduct clinical trials involving gene or stem cell therapies in the U.K. The European Medicines Agency (EMA) previously granted Orphan Drug designation for the company's RPE cell product for use in treating SMD.

First patients treated in new human embryonic stem cell study

Source: Washington Post
Posted: July 14, 2011 08:30 AM ET

Summary:

The Washington Post reports researchers have treated the first two patients in the second government-authorized attempt to evaluate a therapy created using human embryonic stem cells to treat Stargardt Macular Dystrophy, a progressive form of blindness:

Researchers have treated the first two patients in the second government-authorized attempt to evaluate a therapy created using human embryonic stem cells in the United States. A team led by Steven Schwartz at UCLA administered about 50,000 cells Tuesday into one eye of a volunteer suffering from Stargardt Macular Dystrophy, a progressive form of blindness that usually begins in childhood, and another with Dry Age-Related Macular Degeneration, the leading cause of blindness in the developed world, Advanced Cell Technology, which is sponsoring the study, announced Thursday.

ACT Announces First Patients Undergo Embryonic Stem Cell Transplantation Treatment for Stargardt's Disease and Macular Degeneration

Source: Advanced Cell Technology, Inc.
Date: July 14, 2011

Summary:

MARLBOROUGH, Mass. -- Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, today announced the dosing of the first patients in each of its two Phase 1/2 clinical trials for Stargardt's macular dystrophy and dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patients were treated Tuesday (July 12) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute. Robert Lanza, M.D., chief scientific officer of ACT, attended the procedures. Both patients successfully underwent the outpatient transplantation surgeries and are recovering uneventfully.

ACT Announces First Patients Enrolled in Two Clinical Trials Using Embryonic Stem Cells to Treat Stargardt's Disease and Dry Age-Related Macular Degen

Source: Advanced Cell Technology, Inc.
Date: June 16, 2011

Summary:

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today the enrollment of the first patients in its two Phase 1/2 clinical trials for Stargardt's Macular Dystrophy (SMD) and Dry Age-Related Macular Degeneration (Dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patients were enrolled at the Jules Stein Eye Institute at the University of California, Los Angeles (UCLA).

The Phase 1/2 trials are prospective, open-label studies primarily designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with SMD and Dry AMD. Each study will enroll 12 patients with cohorts of three patients in an ascending dosage format. The primary endpoint of both studies is to determine the safety and tolerability of hESC-derived RPE cells at 12 months.

Stem Cells from Patients Make 'Early Retina in a Dish'

Source: University of Wisconsin - Madison
Date: June 15, 2011

Summary:

Soon, some treatments for blinding eye diseases might be developed and tested using retina-like tissues produced from the patient's own skin, thanks to a series of discoveries reported by a team of University of Wisconsin-Madison stem cell researchers.
The team, led by stem cell scientist and ophthalmologist Dr. David Gamm of the UW School of Medicine and Public Health and former UW scientist Dr. Jason Meyer, used human embryonic stem (ES) cells and induced pluripotent stem (iPS) cells to generate three-dimensional structures that are similar to those present at the earliest stages of retinal development. The research is published online in the journal Stem Cells.

Sections of Retinas Regenerated and Visual Function Increased With Stem Cells from Skin

Source: Schepens Eye Research Institute
Date: May 16, 2011

Summary:

Boston, MA— Scientists from Schepens Eye Research Institute are the first to regenerate large areas of damaged retinas and improve visual function using IPS cells (induced pluripotent stem cells) derived from skin. The results of their study, which is published in PLoS ONE this month, hold great promise for future treatments and cures for diseases such as age-related macular degeneration, retinitis pigmentosa, diabetic retinopathy and other retinal diseases that affect millions worldwide.

Self-Made Eye: Formation of Optic Cup from Embryonic Stem Cells

Source: RIKEN Center for Developmental Biology
Date: April 7, 2011

Summary:

New research from the RIKEN Center for Developmental Biology shows how mouse stem cells spontaneously form into optic cups, the precursors of eyes. The research sheds light on the embryonic development of complex tissues. A breakthrough report describes how mouse embryonic stem cells (ESCs) are able to differentiate and assemble into an optic cup, capable of giving rise to a tissue exhibiting the stratified structure characteristic of the retina in vivo. Published in Nature, the study used a cutting-edge three-dimensional tissue culture system not only to demonstrate this self-organizing capacity of pluripotent stem cells, but the underlying cell dynamics as well.

The self-made eye: Formation of optic cup from ES cells

Source: Riken Institute / Riken Cener for Developmental Biology
Date: April 7, 2011

Summary:

Developmental processes are increasingly well-characterized at the molecular and cell biological levels, but how more complex tissues and organs involving the coordinated action of multiple cell types in three dimensions is achieved remains something of a black box. One question of particular interest and importance is whether signaling interactions between neighboring tissues are essential to guiding organogenesis, or whether these can arise autonomously from developmental routines inherent to a given primordial tissue. Finding answers to these questions will be critical both to a better understanding of embryonic phenomena and to the ability to control the differentiation of cell populations into desired configurations.

In a breakthrough new report, RIKEN Cener for Developmental Biology researchers describe how mouse embryonic stem cells (ESCs) are able to differentiate and assemble into an optic cup, capable of giving rise to a tissue exhibiting the stratified structure characteristic of the retina in vivo. Published in Nature, the study used a cutting-edge three-dimensional tissue culture system not only to demonstrate this self-organizing capacity of pluripotent stem cells, but the underlying cell dynamics as well.

Stem cell therapy for age-related macular degeneration -- a step closer to reality

Source: Georgetown University Medical Center
Date: March 24, 2011

Summary:

Washington, D.C. – The notion of transplanting adult stem cells to treat or even cure age-related macular degeneration has taken a significant step toward becoming a reality. In a study published today in Stem Cells, Georgetown University Medical Center researchers have demonstrated, for the first time, the ability to create retinal cells derived from human-induced pluripotent stem cells that mimic the eye cells that die and cause loss of sight. The research shows that this critical step in regenerative medicine for AMD has greatly progressed.

Advanced Cell Technology Receives FDA Clearance For Clinical Trials Using Embryonic Stem Cells to Treat Age-Related Macular Degeneration

Source: Advanced Cell Technology, Inc.
Date: January 3, 2011

Summary:

MARLBOROUGH, MA – Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that the US Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). ACT is now permitted to initiate a Phase I/II multicenter clinical trial to treat patients with Dry AMD, the most common form of macular degeneration in the world. There are currently no treatments available for this prevalent disease of an aging global population. Dry AMD, representing a substantial global market opportunity and afflicts between 10-15 million Americans.

Medical News Today, The Los Angeles Times, Agence France Presse (AFP) and Bloomberg News carried news stories about the trial today.

Coverage Summary: Advanced Cell Technology Receives FDA Clearance For Rare Disease

Below is a summary of media coverage about the announcement by Advanced Cell Technology Inc. that it received FDA approval for the first clinical trial Using embryonic stem cells to treat Stargardt disease, a form Macular Degeneration:

Associated Press, November 25, 2010 at 9:06 PM: "Test OK'd for stem-cell treatment of rare disease":

NEW YORK — For only the second time, the U.S. government has approved a test in people of a treatment using embryonic stem cells — this time for a rare disease that causes serious vision loss. Advanced Cell Technology (ACT), a biotechnology company based in Santa Monica., Calif., said the research should begin early next year, following the green light from the U.S. Food and Drug Administration.

...ACT's experiment will focus on Stargardt disease, which affects only about 30,000 Americans. But the company hopes the same approach will work for similar and more common eye disorders like age-related macular degeneration, which affects millions. Stargardt is an inherited disorder that attacks central vision used for tasks like reading and recognizing faces. Some patients go totally blind, even losing peripheral vision, while others are severely impaired and can only perceive light or see their hands moving in front of their faces.

...The disease typically starts in adolescence. The key problem is that impaired scavenger cells fail to remove toxic byproducts from the eye, allowing them to build up and kill other cells. There is no proven treatment. In the new study, 12 patients will be treated with healthy scavenger cells, created in a laboratory from human embryonic stem cells. This early phase of the research is primarily to test the safety of various doses, injecting only one eye of each patient.

Los Angeles Times, November 22, 2010, 2:02 p.m.: "FDA clears second clinical trial involving human embryonic stem cells":

Another therapy derived from human embryonic stem cells is headed for clinical trials. Advanced Cell Technology Inc. said Monday that the Food and Drug Administration has cleared the way for its Phase I/II trial of retinal cells for patients with Stargardt’s macular dystrophy, a childhood version of macular degeneration. Up to 12 patients will be enrolled at several sites across the country, including the Casey Eye Institute in Portland, Ore., the University of Massachusetts Memorial Medical Center in Worcester, and UMDNJ – New Jersey Medical School in Newark.

...Advanced Cell Technology hopes to treat these patients by giving them new retinal pigment epithelium cells to replace the ones that are lost to the disease. The therapy has restored vision in rats and mice, according to published studies. The Phase I/II trial is designed to test the safety and tolerability of the RPE cells in humans.

Reuters, November 22, 2010 5:20pm EST: "Second U.S. company gets stem cell go-ahead":

The U.S. Food and Drug Administration has approved the second human trial of human embryonic stem cells -- this one testing cells in people with a progressive form of blindness, the company said on Monday. Massachusetts-based Advanced Cell Technology said it would start testing its stem cell-based treatment on 12 patients with Stargardt's macular dystrophy. It is the second trial of human embryonic stem cells to be approved by the FDA this year. Last month Geron Corp enrolled the first patient in its study using the cells in people whose spinal cords have been crushed.

Time, November 22, 2010: "FDA Approves Second Trial of Stem-Cell Therapy":

For only the second time, the Food and Drug Administration approved a company's request to test an embryonic stem cell-based therapy on human patients. Advanced Cell Technology (ACT), based in Marlborough, Mass., will begin testing its retinal cell treatment this year in a dozen patients with Stargardt's macular dystrophy, an inherited degenerative eye disease that leads to blindness in children. ...ACT's trial will involve injecting retinal pigment epithelium (RPE) cells, which nurture the retina, into volunteers with the most advanced forms of Stargardt's, in an attempt to replace dying and no longer functioning photoreceptor cells. In animals, the infusion of healthy cells improved vision and rescued the function of some diseased cells.

New Scientist, 22 November 2010, 16:36 GMT: "Stem cell trial for blindness gets green light":

Twelve people left almost blind by a hereditary condition that strikes in childhood are to receive the world's first eye therapy derived from human embryonic stem cells (hESCs). The treatment is for Stargardt's macular dystrophy, which affects 1 in 8000 people in the US. Their sight deteriorates from around age 6 when retinal pigment epithelial cells (RPEs) start to die off rapidly, possibly due to a defective gene. Without RPEs to support and nourish them, adjacent photoreceptor cells which capture light signals, die too and blindness is the result. People in the trial will be those whose vision has deteriorated to the point where they can see the movement of their own hand, but little else. They will receive injections into their eyes of between 50,000 and 200,000 RPEs.

"The goal is to halt the rate of photoreceptor loss," says Robert Lanza, chief scientist at Advanced Cell Technology (ACT) of Worcester, Massachusetts, the company that has been developing the treatment since first turning hESCs into RPEs in 2004. By implanting new RPEs, which do not contain the defective gene, the team hopes to prevent further deterioration or perhaps even reverse it.

Boston Globe, November 22, 2010: "ACT wins FDA’s approval to test stem cell therapy":

Advanced Cell Technology, a stem cell company with a research laboratory in Marlborough, has received federal approval to test a human embryonic stem cell treatment on patients with a rare disease that causes blindness. ...ACT filed an investigational new drug application with the Food and Drug Administration a year ago to use retinal cells derived from human embryonic stem cells to treat patients with Stargardt’s, a rare genetic disease that affects about 30,000 people in the United States. The disease causes progressive vision loss, starting in patients between 10 and 20 years old, and results in blindness.

Advanced Cell Technology Receives FDA Clearance For the First Clinical Trial Using Embryonic Stem Cells to Treat Macular Degeneration

Source: Advanced Cell Technology, Inc.
Date: November 22, 2010

Summary:

MARLBOROUGH, MA – Advanced Cell Technology, Inc. announced today that the US Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to immediately initiate a Phase I/II multicenter clinical trial using retinal cells derived from human embryonic stem cells (hESCs) to treat patients with Stargardt’s Macular Dystrophy (SMD), one of the most common forms of juvenile macular degeneration in the world. The decision removes the clinical hold that the FDA had placed on the trial.

Biosynthetic corneas restore vision in humans

Source: Ottawa Hospital Research Institute
Date: August 25, 2010

Summary:

A new study from researchers at Ottawa Hospital Research Institute in Canada and Linköping University in Sweden has shown that biosynthetic corneas can help regenerate and repair damaged eye tissue and improve vision in humans. The results, from an early phase clinical trial with 10 patients, are published in the August 25th, 2010 issue of Science Translational Medicine.