The UCLA Health System has launched a face transplantation program for patients with devastating facial trauma, burns, or birth defects. It is the first such program in the western United States. The organizers of the program are currently looking to recruit potential patients with severe facial disfigurement who would be interested in enrolling as five-year study volunteers. Potential patients can come from anywhere in the United States.
The institution has a strong track record in transplantation medicine. It has performed more than 5000 liver transplants since 1984 and performs advanced research in immunology and immunosuppression that is necessary to conduct a transplantation program. In addition, UCLA has a strong commitment to advancing microsurgery and craniofacial surgery.
“Facial transplantation essentially, in my opinion, is the beautiful marriage of those disciplines: transplant surgery, microsurgery, craniofacial surgery, and immunology/immunosuppression,” Reza Jarrahy, MD, co-surgical director of the face transplantation program told Medgadget. “At UCLA, we have a longstanding history of performing these types of procedures independently at a very high level. The next evolution is to sort of marry these disciplines and offer this face transplantation service to patients.
Brian Klein, Medgadget: I understand that performing a face transplantation can take anywhere from eight to 20 hours. How does a surgeon prepare oneself for such an intense ordeal?
Reza Jarrahy, MD: Surgeons are an interesting breed. People ask me that all of the time. And we do [somehow make it through these long procedures]. People who do complex head and neck reconstruction or transplantation do, too. And one of the members of our team has done the West Coast’s first hand transplant, which was a 24-hour operation.
I would say we are so focused and in the zone that we really don’t notice the time. The amount of focus and attention that it takes to operate at the level really supersedes any other physical, psychological, or emotional issue that might come up. We can sit an operating table for, say, four, six, or eight hours without even needing to get up and have any sort of break.
In terms of the psychological preparedness, I think for those of us who are involved in the program are a little bit unique. The face transplantation program is a little bit of a unique endeavor. But, for those of use who are involved in the process, we have been thinking about this for quite some time. We have been reading about all of the other experiences that have been going on with face transplantation worldwide.
I am pretty certain that when we get right down to it, it is going to be like everything else we do—getting through all of the technical elements of the operation. And that focus and concentration, I believe, helps us get through the length of the procedure itself.
Medgadget: Is it difficult to coordinate a team of, say, 20 or 30 people in the OR in a procedure like this?
Jarrahy: Yes. [laughs] The level of coordination is tremendous. It is not just the 10 to 15 to 20 people who are directly involved in the surgery—it is everyone who is involved before the surgery, in the screening process, all of the doctors and the nurses, ancillary staff, administrative staff—both on the end of the recipient patient at UCLA and the donor patient, wherever they may be. During the operation, there is a tremendous amount of effort. There is only a certain amount of real estate in the operating room. A lot of people need to be in and out of that room. So you have to have a very organized flow and afterwards in taking care of the patient after to make sure the patient is in getting the right care from all of the various disciplines who need to see the patient and take care of them afterwards.
I will say, however, we have a similar coordination issue with hand transplantation and it went pretty flawlessly in our first hand transplant a little over a year ago. I think it is another benefit that we bring to the program—we’ve done it already. Certainly a hand is much different than a face, but in terms of the nuts and bolts—the nitty gritty of actually getting through such a complex procedure, we have done that once before, so we have sort of an idea of what it will take.
Medgadget: What can you tell me about the clinical trial and its endpoints?
Jarrahy: In medicine, when you try something new, and face transplantation is certainly a new endeavor relative to other more established surgical procedures, there are two ways to go about it: One way is to just do it. And the other way is to do it with a lot of scrutiny.
When I say “scrutiny,” I mean before launching this program for the past year, we’ve been working with our institutional review board—the group at UCLA that reviews the intent to do anything that is not sort of a standard of medical care. And we set up databases to collect every little bit of patient data that will come out from treating our patients and to study everything that we have done. I think almost every center that is doing this in the U.S. is doing it on a sort of experimental trial basis. In other words, they have gone through all of these measures. There may be one that is just sort of offering it as a procedure and not labeling it as experimental.
It is a more arduous process on the front end to try and get approval for all of these things. But we think it is very necessary and important because it keeps everyone honest. We cannot just make unilateral decisions as a surgical team and say “we are just going to do this.” There is a huge series of checks and balances from people of various backgrounds and fields including ethicists and psychologists. It really makes us think very carefully about every little decision we want to make in the care of these patients to make sure that decision we end up making is the responsible one, the ethical one, the appropriate one, so we actually get down to doing the surgery, all of those bases have been covered theoretically and everything is being done in the best possible manner for the care of the patient.
For the trial, we have to put some sort of time limit on the trial and we chose five years. We figure over the course of the next five years, we will do several face transplants. And from those procedures, we can gather a lot of data and present that data to the scientific community. We can say “here’s our experience with face transplantation, here’s what we think are the best protocols in terms of screening patients before surgery,” in terms of coordinating the surgery while it is actually going on, in terms of treating the patient with immunosuppression medications after. Hopefully, we’ll contribute to this evolving field and make it better as we go ahead.
Medgadget: I understand that every patient is different, but to what extent can a patient suffering from severe facial injury or deformity regain normal function after a face transplant?
Jarrahy: Based on what we have seen from some other centers around the world, those expectations are quite high. You are absolutely right; it does depend on the severity of the deformity. Some deformities involve only the soft tissue and it is more of a form issue and not as much of a functional issue.
The goal there is to restore the form. When the deformities are more complex and involve soft tissue and the underlying skeleton—the upper jaw and the lower jaw. And there are functional issues such as speech or swallowing, et cetera.
We are also really focused on functional improvement and the expectation is very high that patients will return to, if not “normal,” at least a very strong sense of normalcy in terms of just basic functions like speaking and eating,
Medgadget: What is the cutting edge now of face transplant surgery and where do you see the next breakthroughs going forward?
Jarrahy: Face transplantation is interesting in that what we are doing in the operating room is not necessarily new. We have done solid organ transplantation for decades. We do very complex craniofacial surgery at UCLA. We have been a leading center of microsurgery for many years and so the surgical techniques that we are using are not necessarily new by any means. The novelty is combining all of these disciplines into one.
The frontier is going to be actually in the surgical realm but in the medical realm because as you probably know, patients who receive any sort of transplant from another human being have to go on immunosuppressant medication for the rest of their lives. The immunosupresssion medication are really what we are concerned about in transplantation once we get out of the initial of the operation itself. Then we turn out attention to immunosuppression because it can cause problems down the line. The future of face transplantation and any transplant sort of surgery is in developing new ways of delivering the effective immunosuppression medications at the most minimal toxicity. On that end, along with our clinical program of actually doing the operations, we have a very active basic science and research program that is led by one of the world’s top immunologists who has been doing this with our liver transplant program for almost two decades now. To try and get there, they will try to develop those immunosuppression protocols that will enable the post-operative phase for the long term to be as benign as possible for our patients.
UCLA is now seeking patients willing to participate in a face-transplant clinical trial and to be followed for five years after their surgery. As a news release from UCLA’s Office of Media relations explains:
Candidates for the clinical trial will undergo a thorough evaluation to determine whether they meet the criteria for participation. The evaluation includes a comprehensive medical history, a physical examination, lab tests, X-rays and a psychological exam. Approved participants will be placed on a waiting list until the center identifies a suitable match from a donor. Recipients must match the donor’s blood type, gender, ethnicity, skin tone, hair pattern and other criteria.
Additional eligibility criteria for the clinical trial include:
• The patient’s facial disfigurement cannot be repaired by conventional surgery.
• The disfigurement is not due to a birth defect.
• The patient’s age is between 18 and 60 years.
• The patient has no serious infections, including HIV or hepatitis B or C.
• The patient is in otherwise good general health.
• The patient must commit to extensive rehabilitation after surgery, including soft-tissue massage and speech, swallowing and facial-movement therapies.
• The patient must agree to follow a drug schedule to prevent transplant rejection and attend all appointments at the transplant center.
Link: UCLA launches first face transplantation program in western U.S.