BBC NEWS Website wrote:Advanced Cell Technology: Stem cell retinal implants safe

Early results from the world's first human trial using embryonic stem cells to treat diseases of the eye suggest the method is safe, say researchers. US firm Advanced Cell Technology told The Lancet how two patients who had received the retinal implants were doing well, four months on.

The aim of these first human studies is to establish that the treatment is safe to use. The treatment takes healthy immature cells from a human embryo, which are then manipulated to grow into the cells that line the back of the eye - the retina. Experts hope that by injecting these cells into a diseased eye, they will be able to restore vision for people with currently incurable conditions such as Stargardt's disease - one of the main causes of blindness in young people.

Advanced Cell Technology, along with the Jules Stein Eye Institute at the University of California, Los Angeles, are reporting their first experiences with this treatment in human trials. The study involved one elderly patient in her 70s with dry age-related macular degeneration - the leading cause of blindness in the developed world - and another female patient in her 50s with Stargardt's disease.

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After surgery, structural evidence confirmed the cells had attached to the eye's membrane as hoped, and continued to survive throughout the next 16 weeks of the study. Furthermore, the procedure appeared to be safe, causing no signs of rejection or abnormal cell growth.

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But even if this does become possible, such treatments would face stiff opposition by critics who say it is ethically wrong to use human embryonic tissue. Dr Dusko Ilic, Senior Lecturer in Stem Cell Science at Kings College London, said that these early findings did not necessarily hint towards a viable treatment.

"We should keep in mind that people are not rats. The number one priority of initial clinical trial is always patient safety. If everyone expects that the blind patients will see after being treated with human embryonic stem cell-derived retinal pigment epithelium, even if the treatment ends up being safe (which is what Advanced Cell Technology are trying to determine in this trial), they risk being unnecessarily disappointed."

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Schwartz et al wrote:Human embryonic stem cells trials for macular degeneration

• Steven D. Schwartz, MD, chief, retina division, Jules Stein Eye Institute, Los Angeles.
• Anthony Atala, MD, director, Institute for Regenerative Medicine, Wake Forest University.
• Robert Lanza, MD, chief scientific officer, Advanced Cell Technology Inc., Marlborough, Mass.

Summary

Background: It has been 13 years since the discovery of human embryonic stem cells (hESCs). Our report provides the first description of hESC-derived cells transplanted into humans

Method: We started two prospective clinical studies to establish safetly and tolerability of subretinal transplantation of hESC-derived retinal pigment epithelium (RPE) in patient with Stargardt's macular dystrophy and dry age-related macular degeneration--the leading cause of blindness in the Western world. Pre-operation and post-operation ophthalmic examinations included visual acuity, fluorescein angiography, optical coherence tomography, and visual field testing. These studies are registered with ClinicalTrials.gov numbers NCT01345006 and NCT01344993.

Findings: Controlled hESC differentiation resulted in greater than 99% pure RPE. The cells displayed typical RPE behaviour and integrated into the host RPE layer forming mature quiescent monolayers after trans plantation in animals. The stage of differentiation substantially affected attachment and survival of the cells in vitro after clinical formulation. Lightly pigmented cells attached and spread in a substantially greater proportion (>90%) than more darkly pigmented cells after culture. After surgery, structural evidence confirmed cells had attached and continued to persist during our study. We did not identify signs of hyperproliferation, abnormal growth, or immune mediated transplant rejection in either patient during the first 4 months. Although there is little agreement between investigators on visual endpoints in patients with low vision, it is encouraging that during the observation period neither patient lost vision. Best corrected visual acuity improved from hand motions to 20/800 (and improved from 0 to 5 letters on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual acuity chart) in the study eye of the patient with Stargardt’s macular dystrophy, and vision also seemed to improve in the patient with dry age-related macular degeneration (from 21 ETDRS letters to 28).

Interpretation: The hESC-derived RPE cells showed no signs of hyperproliferation, tumorigenicity, ectopic tissue formation, or apparent rejection after 4 months. The future therapeutic goal will be to treat patients earlier in the disease processes, potentially increasing the likelihood of photoreceptor and central visual rescue.

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trubble76 wrote:Get more babies in the blender.

mrjonno wrote:

But even if this does become possible, such treatments would face stiff opposition by critics who say it is ethically wrong to use human embryonic tissue. Dr Dusko Ilic, Senior Lecturer in Stem Cell Science at Kings College London, said that these early findings did not necessarily hint towards a viable treatment.

Where are such people?, not a lot around in the UK and probably zero for anyone who is going blind