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Regenerative Patch Technologies, a company developing stem-cell-derived treatments for people with retinal diseases, has reported encouraging results for the first five patients with advanced, dry age-related macular degeneration (AMD) participating in a Phase 1/2a clinical trial for its therapy – a patch comprised of a layer of retinal pigment epithelial (RPE) cells on a synthetic scaffold. The treatment is known as the California Project to Cure Blindness–Retinal Pigment Epithelium 1 (CPCB-RPE1).
One patient in the trial had visual acuity improvement of 17 letters (about 3 lines on an eye chart) in her treated eye. Three patients had vision maintained in their treated eyes. Two had improved fixation. One patient did not receive the patch due to debris underneath the retina. No evidence of safety issues with the treatment was observed.
The study investigators also reported anatomic improvements in the treated eyes. Imaging showed that the transplanted RPE cells integrated with photoreceptors, the cells that make vision possible.
In people with advanced AMD, RPE cells degenerate leading to loss of photoreceptors. RPE cells provide critical support functions – including nutrition and waste management – for photoreceptors. The RPE cells used in Regenerative Patch’s emerging therapy are derived from human embryonic stem cells.
The treatment’s scaffold mimics Bruch’s membrane, which breaks down in people with AMD. Also known as the blood-retina barrier, Bruch’s membrane works like a sieve to transport waste debris to, and nutrients from, the retina’s vasculature.
“People with advanced dry AMD have very limited options for saving or restoring their vision,” says Stephen Rose, PhD, chief scientific officer at the Foundation Fighting Blindness. “These early results from the California Project to Cure Blindness are good news for these patients. We look forward to learning more about the therapy as the trial moves forward.”
Initial results of the clinical trial were published online in the journal Science Translational Medicine. Authors of the paper include Mark Humayun, MD, PhD, at the University of Southern California (USC), developer of the Argus bionic retina; Amir Kashani, MD, PhD, surgeon at USC; and Dennis Clegg, PhD, at the University of California, Santa Barbara, who has been funded by the Foundation Fighting Blindness to develop scaffolding for a therapeutic retinal patch in development at the University of Wisconsin-Madison.
Good job and keep the good work
This is amazing news! Would this procedure also possibly apply to a person who has lost vision in one eye due to retinal detachment and issues stemming from diabetes?
Hi Barbara, this clinical trial is only being completed for those with dry AMD at this moment.
Thanks for the effort
I would like tp enter your ” Retinal Patch Trial.
Kindly contact me with details.
Thank you,
Marsha Peckler
Hi Marsha, you can enroll in this trial by visiting their clinicaltrials.gov website here: https://clinicaltrials.gov/ct2/show/NCT02590692 You can contact any of the recruiting locations. Good luck!
This is wonderful news.Thank you.
When do you think this wonderful breakthrough will be available?
Hi Alice, unfortunately there’s no way of knowing an exact timeline, but this trial is still recruiting for those interested in participating. You find learn who to contact to participate here: https://clinicaltrials.gov/ct2/show/NCT02590692
I have a genetic disorder which causes the rods and cones to degenerate . Is this treatment going to help people with my condition?
Hi Richard, this trials is currently only for patients with dry AMD. But we recommend searching for other clinical trials for your condition on http://www.clinicaltrials.gov. Good luck!
Where can this be performed? My husband has
Dry AMD..
Thank you.
Hi William, there are multiple locations that are recruiting for this trial. You can find those locations and contact information by visiting: https://clinicaltrials.gov/ct2/show/NCT02590692