Landmark whole-eye transplant is a major paradigm shift for potential vision therapies.

A surgical team from NYU Langone Health performed the world’s first whole-eye and partial face transplant for a 46-year-old military veteran from Arkansas who survived a work-related high-voltage electrical accident. The surgery included transplanting the entire left eye and a portion of the face from a single donor, making this the first-ever human whole-eye transplant in medical history and the only successful combined transplant case of its kind.

While it is still unknown whether he will regain sight, since the May 2023 procedure, the transplanted left eye has shown remarkable signs of health, including direct blood flow to the retina  the area at the back of the eye that receives light and sends images to the brain. Although many questions remain in a case with no precedence, this groundbreaking achievement opens new possibilities for future advancements in vision therapies and related medical fields.

 

Aaron James and Patrick Hardison meet - another face transplant recipient.

 

About the Procedure

The May 27 surgery lasted approximately 21 hours and included a team of more than 140 surgeons, nurses and other healthcare professionals, led by Eduardo D. Rodriguez, MD, DDS, director of the Face Transplant Programme, the Helen L. Kimmel Professor of Reconstructive Plastic Surgery, and chair of the Hansjörg Wyss Department of Plastic Surgery at NYU Langone.

The recipient, Aaron James of Hot Springs, Arkansas, survived a deadly 7200-volt electric shock while working as a high-voltage lineman in June 2021, when his face accidentally touched a live wire. Despite multiple reconstructive surgeries, James had extensive injuries  including the loss of his left eye, his dominant left arm from above the elbow, his entire nose and lips, front teeth, left cheek area, and chin down to the bone.

“Aaron has been extremely motivated to regain the function and independence he lost after his injury. We couldn’t have asked for a more perfect patient,” said Dr Rodriguez. “We owe much of our success in this monumental endeavor to the exceptional institutional support we receive at NYU Langone and the unwavering dedication of our world-class team in delivering the highest level of care to our patient. This achievement demonstrates our capacity to embrace the most difficult challenges and drive continuous advancements in the field of transplantation and beyond.”

The NYU Langone team was introduced to James’ case just two months after his injury, allowing guidance during the early-phase reconstructions with specialists at a Texas medical center where he was receiving care. The possibility of a face transplant was discussed over the next year, and an initial evaluation for the transplant took place one year following the initial injury in June 2022.

When Texas surgeons were forced to remove James’ left eye after injury due to severe pain, Dr Rodriguez and his team recommended that the optic nerve be cut as close to the eyeball as possible, to preserve as much nerve length to maximize reconstructive options, including the hope of a potential transplant later. This began the discussion on the possibility of including an eye with the face, something that has never been attempted before.

NYU Langone’s multidisciplinary team, Dr Rodriguez, and the James family collectively made the decision to move ahead with a whole-eye transplant in combination with the face – understanding that at best it may only provide cosmetic benefits but leave many unknowns. “Given James needed a face transplant and will be taking immunosuppressive drugs regardless, the risk versus reward ratio of transplanting the eye was very low. Despite the eye being successfully transplanted, from a cosmetic standpoint, it would still be a remarkable achievement,” said Dr Rodriguez.

This is the fifth face transplant performed under the leadership of Dr Rodriguez and the first known whole-eye transplant in existence. “The mere fact that we’ve accomplished the first successful whole-eye transplant with a face is a tremendous feat many have long thought was not possible,” added Dr Rodriguez. “We’ve made one major step forward and have paved the way for the next chapter to restore vision.”

 

Credit - Joe Carrotta.

 

One of the shortest wait times for a donor – three months

Once James’ case cleared all approvals within NYU Langone, he was officially listed as a potential recipient in February 2023 with the United Network for Organ Sharing (UNOS), the private, nonprofit organisation that manages the nation’s organ transplant system.

Locally, the effort to find a donor for James was led by LiveOnNY, the organ procurement organisation for the greater New York metropolitan area. In May 2023, just three months after James was listed for organ donation, coordinators from LiveOnNY identified a potential donor at another hospital in New York City. After a series of donor evaluations – including tests to determine if the eye was healthy and viable, led by Vaidehi S. Dedania, MD, retina specialist in the Department of Ophthalmology at NYU Langone – he was deemed an ideal donor. The total time from injury to transplant was a little under two years.

“The donor hero was a young man in his 30s who came from a family that strongly supports organ donation. He, in support by his family, generously donated tissues leading to this successful face and eye transplant, but also saved three other individuals between the ages of 20 and 70, donating his kidneys, liver, and pancreas,” said Leonard Achan, RN, MA, ANP, president and CEO of LiveOnNY. “LiveOnNY is proud to have collaborated with such a distinctive team of medical professionals at NYU Langone. This act of grace and innovative surgical procedure will have a multigenerational impact on all the recipients and their loved ones."

 

A Question of Nerve

While corneal transplants have become relatively common, with thousands performed in the United States each year, successful whole-eye transplants to restore vision have remained elusive due to the complex nature of the eye and the challenges associated with nerve regeneration, immune rejection, and retinal blood flow.

The human eye is intricately connected to the brain through the optic nerve, part of the central nervous system and responsible for transmitting visual information to the brain. Reestablishing these nerve connections successfully is a fundamental requirement for a whole-eye transplant to restore vision and one of the biggest challenges.

Dr Rodriguez, in collaboration with the team at NYU Langone’s Transplantation and Cellular Therapy Center, part of the Blood and Marrow Transplant Program at Perlmutter Cancer Center, made the decision to combine the donor eye with donor bone marrow-derived adult stem cells. Bone marrow is a sponge-like tissue found inside the large bones in the body. Adult stem cells that are transplanted can work as a replacement therapy and natural repair crew, dividing again and again to create heathy cells that replace the damaged or dysfunctional elements.

“This is the first attempt of injecting adult stem cells into a human optic nerve during a transplant in the hopes of enhancing nerve regeneration,” said A Samer Al-Homsi, MD MBA, executive director of the Transplantation and Cellular Therapy Center, and professor in the Department of Medicine at NYU Langone. “We chose to use CD34-positive stem cells which have been shown to harbor the potential to replace damaged cells and neuroprotective properties.”

During the transplant, bone marrow that was harvested from the donor’s vertebrae and processed preoperatively to isolate the CD34-positive stem cells was brought into the operating room (OR) and injected at the optic nerve connection of the recipient.

"We have now demonstrated that the procedure is safe and potentially efficacious, but we need time to determine if this step plays a role in enhancing the chance of sight restoration, and if there’s anything further that can be done in the future to optimize the procedure,” added Dr Al-Homsi.

 

Innovations in Face Transplant Technology

Through collaboration with Depuy Synthes, the Orthopedics Company of Johnson & Johnson, and Materialise, state-of-the-art technology played a pivotal role in both presurgical planning and the actual surgery. Cutting-edge three-dimensional (3D) computer surgical planning, along with patient-specific 3D cutting guides, enabled precise alignment of bones and optimal placement of implantable plates and screws. This meticulous approach fit the grafted partial face and whole left eye onto James.

The successful surgery took place in NYU Langone’s Kimmel Pavilion, where expansive ORs enabled two highly skilled surgical teams to simultaneously operate in both the donor and recipient rooms. The surgical teams adhered to a carefully planned timetable  which was rehearsed many times over the last year – as the team proceeded with the transplantation and reconstruction process, seamlessly integrating the donor’s face and eye onto James as quickly as possible to ensure the optimal outcome. Dr Rodriguez and his surgical team of 7  and OR team of 80  transplanted the following:

  • partial face, including the nose, left upper and lower eyelids, left eyebrow, upper and lower lips, and underlying skull, cheek, nasal and chin bone segments, with all of the tissues below the right eye including the underlying muscles, blood vessels and nerves
  • left whole-eye and socket including the orbital bones and all surrounding eye tissues including the optic nerve.

As they do in all transplant operations, the surgeons sought to complete the procedure as quickly as possible to limit the ischemia time, or the amount of time the donated tissue is not receiving a blood supply.

“The progress we’ve seen with the eye is exceptional, especially considering that we have a viable cornea paired with a retina showing great blood flow five months after the procedure. This far exceeds our initial expectations, given our initial hope was that the eye would survive at least 90 days,” said Bruce Gelb, MD, a transplant surgeon at the NYU Langone Transplant Institute and vice chair of quality in the Department of Surgery. “We will continue to monitor, and I am excited to see what else we may learn over time.”

Dr Rodriguez has since performed a less extensive follow-up surgery for James to optimize his functional and aesthetic outcome. James plans to have orthodontic treatment and dental rehabilitation in the coming months.

“Beyond the eye, the quality of Aaron’s results from the face transplant is special. You would never think he underwent such a procedure so recently. He looks great,” said Dr Rodriguez.

The NYU Langone team has set the standard in the field of face transplants for eliminating and avoiding early rejection episodes as well as the frequency of rejections using a unique immunosuppression regimen.

As in previous face transplants, Dr Rodriguez and his team collaborated with NYU’s advanced 3D media services center, LaGuardia Studio, to create a 3D-printed replacement of the donor’s face to restore the integrity of the donor’s identity after the organs were removed to return to his family. Traditionally, a molded, hand-painted silicone mask had been used. There are few printers in the world like the one at LaGuardia, which prints with 60,000 colors.

 

Aaron James and Director of the Face Transplant Programme, Eduardo D. Rodriguez.

 

A Determined Patient Focused on Healing

Following the surgery, James spent just 17 days in the intensive care unit at NYU Langone, one of the shortest recoveries among Dr Rodriguez’s face transplant recipients. He was discharged on July 6 to a nearby apartment. From there, he continued outpatient rehabilitation including physical, occupational, and speech therapy.

James continues to remain positive and eternally grateful to regain many elements of life he lost after the 2021 injury, especially the ability to taste, smell, and eat solid foods. On September 14, he returned home to Arkansas with his wife, Meagan, and daughter, Allie. James comes back to New York City monthly for follow-up appointments. He has the option to return to work as a safety manager for high-voltage line workers in the future.

“I’m grateful beyond words for the donor and his family, who have given me a second chance at life during their own time of great difficulty. I hope the family finds solace in knowing that part of the donor lives on with me,” said James. “I will also forever be thankful to Dr Rodriguez and his team for changing my life. My family and I wouldn’t have been able to navigate this difficult journey without their expertise and support. Our hope is that my story can serve as inspiration for those facing severe facial and ocular injuries.”

James is looking forward to spending the upcoming Thanksgiving holiday with his family, getting to enjoy eating a holiday meal for the first time since his injury.

 

Credit - Meagan James

 

Seeing the Future

While James’ vision in his native right eye is intact, the transplanted left eye does not currently have any sight. However, over the last six months, his eye has shown remarkable signs of health in other regards based on various clinical tests that measure outcome.

Dr Rodriguez, Dr Dedania, and a multidisciplinary team of world-renowned researcher scientists and clinicians – including leaders in neurology, ophthalmology, radiology, and neuroradiology – continue to convene and discuss questions that remain related to the eye and ways to measure any indications toward sight restoration.

“What we’re witnessing now is not something we ever expected or thought we’d see,” said Dr Dedania, who runs regular tests for James in relation to his eyes. “The first step is having an intact eyeball, a lot of things could come after that; this is a first in the world, so we are really learning as we go.”

James will continue to have various clinical tests on the left transplanted eye, including electroretinography, a test that measures the electrical response of the retina to light.

“This is certainly one extraordinary step in the right direction,” said Steven L. Galetta, MD, renowned neuro-ophthalmologist and the Philip J. Moskowitz, MD, Professor and Chair of Neurology at NYU Langone. “We’re now crossing into the frontier of the central nervous system. Whatever happens next allows the opportunity for various methods to try to enhance the remaining aspects of the retina, whether it be through growth factors, stem cells, or a device that can pick up the signals and then bypass things along that optic nerve pathway. I’m looking forward to further advancements from this case in collaboration with the very talented minds that made it happen here at NYU Langone.”