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news.Ocata Therapeutics, a leader in the field of Regenerative Ophthalmology, announced that a study has been published that includes top-line, positive results in Asian patients who were treated with Ocata’s proprietary RPE cells, manufactured using its DeltaCell Technology.
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These new data support previously reported positive long-term safety and signs of visual improvement, as presented in The Lancet of October 15th, 2014.
The Korean study published online in Stem Cell Reports features twelve months of post-transplant follow-up data from four Asian patients; two with Stargardt’s macular degeneration (SMD) and two with dry age-related macular degeneration (AMD).
"The results of this study conducted by CHA Biotech in Asian patients support the findings published in The Lancet in October 2014 and further underscores our leadership in regenerative ophthalmology," said Paul K. Wotton, Ph.D., President and Chief Executive Officer.
"The safe treatment of a total of forty two patients across multiple studies with this novel therapeutic approach in geographically distinct patient populations is encouraging. We look forward to the planned initiation of our comprehensive Phase 2 safety study in dry AMD and a pivotal study in SMD, two disabling diseases where there is no cure available today."
In this study there was no evidence of adverse proliferation, tumorigenic behavior, ectopic tissue formation, or other serious safety issues related to the transplanted cells. Although designed as a safety study, visual acuity improved 9-19 letters in three patients and remained stable (+1 letter) in one patient.
Vision was measured using the widely accepted standard for visual acuity testing, the Early Treatment Diabetic Retinopathy Study visual acuity exam.
Ocata Therapeutics chief scientific officer Robert Lanza said: "These results support the potential safety and efficacy of hESC-derived cells in Asian patients and provides further evidence that hESC-derived cells could serve as a potentially safe new source for regenerative medicine."