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US stem cell company given green light for blindness trials

6 February 2012
Appeared in BioNews 643

US company StemCells Inc have received Food and Drug Administration (FDA) authorisation to carry out clinical trials of their treatment for a leading cause of blindness in over 55-year-olds.

This is the latest in a number of clinical trials assessing the potential use of stem cells as a treatment for dry age-related macular degeneration (AMD), which affects around 30 million people worldwide.

StemCells Inc's treatment, which injects purified central nervous system (CNS) stem cells into the patient's retina, has been approved for phase I/II clinical trials to assess its safety and efficacy.

A total of 16 patients will be enrolled in this trial, and they will receive standard ophthalmological examinations throughout the first year. A separate observational study will then assess the patients over the subsequent four years.

There is currently no cure or treatment for dry AMD, although some trials are attempting to delay the vision loss process. It is caused by the degeneration of the cells below the retina in the eye, which causes a loss of photoreceptors and eventually blindness.

Approval was given following positive results in initial tests using a well-established rat model of retinal disease. Study author Dr Raymond Lund said that in this study, published in the European Journal of Neuroscience, 'the effect on vision was long-lasting and correlated with the survival of [stem cells] more than seven months after transplantation'. Furthermore, there was no evidence of any uncontrolled, tumour-like cell growth, an important result in terms of clinical use.

Recently biotech company Advanced Cell Technology and the Jules Stein Eye Institute at the University of California, Los Angeles reported positive results in clinical trials of stem cell injections to treat two different types of eye disease (reported in BioNews 642).

StemCells Inc has already begun clinical trials with purified stem cells in patients paralysed from spinal cord injuries and also for children with Pelizaeus-Merzbacher disease, a rare degenerative disorder of the central nervous system.

Is the Move in StemCells trustworthy?
24/7 Wall St. |  2 February 2012
StemCells, Inc. Announces Publication of Preclinical Data Demonstrating Its Human Neural Stem Cells Preserve Vision
MarketWatch |  30 January 2012
StemCells, Inc. Receives FDA Authorization for Age-Related Macular Degeneration Clinical Trial
StemCells, Inc. (Press Release) |  2 February 2012
StemCells Trial On Dry AMD Treatment Approved By FDA
Wall Street Journal |  2 February 2012
Transplantation of human central nervous system stem cells – neuroprotection in retinal degeneration
European Journal of Neuroscience |  25 January 2012
5 October 2015 - by Jenny Sharpe 
A potential treatment for wet age-related macular degeneration has been carried out for the first time...
29 July 2013 - by Dr Greg Ball 
Light-sensitive cells found in the retina have been grown from mouse embryonic stem cells (ESCs) and successfully transplanted into the eyes of visually impaired mice, restoring some vision...
28 May 2012 - by Ana Pallesen 
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12 March 2012 - by Dr Nadeem Shaikh 
A potential stem cell therapy for glaucoma – a degenerative eye condition that can lead to blindness – has yielded positive results in animal tests...
31 January 2012 - by Dr Dusko Ilic 
In the last few months of 2011, a couple of stories on human embryonic stem cells hit the headlines. Both were bad news for stem cell researchers...
31 January 2012 - by Rosemary Paxman 
A clinical trial testing the safety of using human embryonic stem cell (hESC) in the treatment of progressive eye conditions has been carried out by researchers in the USA...
31 January 2012 - by Dr Dusko Ilic and Dr Emma Stephenson 
Last week, Advanced Cell Technology (ACT) of Massachusetts, USA, made two important announcements regarding human embryonic stem (hES) cell-based therapies for the potential treatment of Stargardt's dystrophy and age-related macular degeneration, two devastating degenerative disease leading to blindness....
26 September 2011 - by Dr Rachael Panizzo 
UK scientists have been granted approval to begin the first clinical trial using embryonic stem cells (ES cells) in Europe, which they hope could lead to an effective treatment for a degenerative eye disease causing blindness...
18 July 2011 - by Dr Sophie Pryor 
Doctors in the USA have begun treating patients in two clinical trials for degenerative eye diseases. The studies at the Jules Stein Eye Institute at the University of California, Los Angeles (UCLA), will test whether specialised eye cells, which have been produced from human embryonic stem cells (hESCs), can be used to treat dry age-related macular degeneration (dry AMD) and Stargardt's macular dystrophy....
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