In a groundbreaking advance for eye care, Vivienne Hau, MD, PhD, a Clinical Assistant Professor at Kaiser Permanente Bernard J. Tyson School of Medicine (KPSOM) and vitreoretinal surgeon at Kaiser Permanente Riverside Medical Center, has successfully performed a stem cell implant for age-related macular degeneration (AMD). This procedure marks the first such surgery performed within Kaiser Permanente’s Southern California region and only the 17th procedure of its kind worldwide.
Conducted as part of an innovative clinical trial, the surgery aims to use stem cell-derived tissue to replace cells damaged by AMD, a leading cause of vision loss. Unlike traditional approaches requiring extended therapy, this research offers hope that patients may one day regain lost vision through regenerative techniques.
Dr. Hau expressed optimism about the medical breakthrough. “It’s exciting to think for the first time in the history of treating eye disease we may finally be able to regrow parts of the eye that have been lost and bring back some form of vision,” she said.
The operation took place at Kaiser Permanente Riverside Medical Center. It was made possible through the Division of Clinical Trials at the Kaiser Permanente Department of Research & Evaluation.
Stem cell implant surgery for AMD is an experimental but promising treatment that involves surgically implanting stem cell-derived retinal pigment epithelium (RPE) cells under the retina to replace damaged cells and support vision. This procedure has shown potential in clinical trials for safety and visual improvement in patients with severe AMD, though it is not yet a widely available, standard treatment. The surgery involves a complex process of creating new cells, preparing them on a special membrane or as a cell suspension, and then carefully injecting them into the eye to their proper position.
“Dr. Hau continues to lead pioneering research focused on the restoration of vision in debilitating conditions such as diabetic retinopathy and macular degeneration,” said William J Towner, MD, FACP, FIDSA, Physician Director, Clinical Trials for Southern California Permanente Medical Group. “Her work demonstrates significant promise for advancing the field and has the potential to substantially improve outcomes and quality of life for a large patient population.”
After completing the historic procedure, Dr. Hau reflected on how the opportunity emerged and why it represents a milestone for vision restoring research.
Upon joining Kaiser Permanente in 2013, Dr. Hau set out to build a prospective clinical trials program in ophthalmology, something the organization did not yet have. “My chief said she would be very supportive of me building the program,” she explained. By 2016, the first study launched, and the program has since grown substantially. “Since then, we've been involved in probably over 20 studies now. Over that time period, we've developed a reputation within the field for how strong our clinical trials program is here at Kaiser Permanente.”
As the program expanded into areas such as gene therapy and stem cell research, it began to attract recognition. This positioned Dr. Hau’s team to participate in studies that could address conditions with limited or no current treatment options, including the loss of the macula caused by age-related macular degeneration, the leading cause of blindness in older adults. “One way we could potentially treat this is regrowing that tissue,” she said. “If we could regenerate the macula and restore vision, that would be incredible. That's where stem cells could play a role.”
When Dr. Hau learned that Astellas Research Institute of America was exploring such an approach, she pursued the possibility of bringing the study into the Kaiser Permanente system. The organization’s integrated model made it well suited for a complex trial of this kind. “For these complicated studies, which need involvement of multiple entities, Kaiser Permanente became a sought-after place to do [them],” she said. With only a handful of investigators nationwide participating, the procedure marked a major milestone.
Although the surgical steps were familiar to her from other retinal procedures, preparing the stem cells required specialized training. “The actual steps to do the surgery and injection of the stem cells are things I’ve done with other types of retinal surgery. It's not a new technique … Previously, for big bleeds under the macula in wet age-related macular degeneration, I'd inject a blood clot thinner under the retina to break up the blood and prevent scarring. The technique for this study is similar, just using stem cells instead of a thinner,” Dr. Hau said.
The distinction came in handling the cells themselves. “They come spun down in a tiny tube, and I need to break it up and reconstitute it.” She completed virtual training, practiced with Astellas representatives, prepared her surgical team, and consulted with other investigators at institutions including Stanford and Thomas Jefferson University.
Looking ahead, Dr. Hau remains cautiously optimistic. “This is still a very early phase one trial, so it's testing viability and safety,” she said. “It’s going to be several years before it could become FDA approved, but I think it’s promising. Animal models show potential.” While the treatment is far from ready for broad clinical use, the scientific implications are significant. “Being able to regrow lost tissue is pretty incredible, so I'm excited,” she added. “Even if it doesn't get FDA approval, we'll learn about stem cell growth and broader applications.”
