Much has been said—as well as doubted—about stem cell treatment. Latest study conducted by the leading company in the regenerative ophthalmology field, Advanced Cell Technology, Inc. (ACT), reveals its own positive findings on stem cell treatment for particular eye diseases.
The ACT said in a statement that its Phase ½ clinical data indicate positive and long-term safety results of its Retinal Pigment Epithelium (RPE) cells in treating dry age-related macular degeneration (AMD) and Stargardt’s macular degeneration (SMD).
“These study results represent an important milestone and strengthen our leadership position in regenerative ophthalmology,” said ACT president and chief executive officer Paul K. Wotton, Ph.D.
Wotton added that their recent findings emphasize the possibility to replace or repair damaged tissues because of diseases and that the company intends to begin the broad clinical trials of Phase 2 for curing SMD and AMD, diseases with no known effective treatment at present.
SMD affects the eyesight of children and young adults aged six to 20 and may lead to vision loss. AMD, on the other hand, has been considered as the primary cause for the loss of vision among people 50 years old and above.
Published in The Lancet journal, the study [pdf] examined data from 18 patients based in the U.S. who have at least six months of post-transplant follow-up. The two-phased studies offer the very first evidence of mid- to long-term survival, safety, and possible “biologic activity of pluripotent stem cell progeny into humans with any disease.”
The anatomic evidence of the study also established the successful engraftment of RPE cells. To measure vision, the standard Early Treatment Diabetic Retinopathy Study visual acuity test.
Meanwhile, co-senior author of the research paper and ACT chief scientific officer Robert Lanza, M.D., also said that eye diseases “are attractive first-in-man applications for this type of investigational therapy due to the immune-privileged nature of the eye.”
Lanza further said that regardless of the degenerative nature of such eye diseases, they discovered that the eyesight of 10-18 patients demonstrated measurable improvement at their six-month follow-up, following the RPE cells transplantation. He elaborated that the cells were well tolerated for an average 22-month period, with two patients treated over three years ago.
“We are pleased that there have been no serious safety issues attributable to the cells observed in any of the patients,” said Lanza.
Paper’s lead author and principal investigator also shared his thoughts about the recent findings.
“This is a hopeful and exciting time for ophthalmology and regenerative medicine,” said Steven Schwartz, M.D., who is also Ahmanson Professor of Ophthalmology at UCLA’s David Geffen School of Medicine as well as retina division chief at UCLA’s Jules Stein Eye Institute.
Schwartz said that the published findings support the possible biological activity and safety of retinal tissue derived from stem cell, adding that such “regenerative strategy should move forward.”