2023-10-29 09:05:14
by Ruggiero Corcella
the goal being worked on by Professor Muhammad Mohiuddin, University of Maryland (USA), author of the first two implants of this kind on humans in the world
Of course, he tells Corriere della Sera: I have achieved what I would never have imagined in my dreams. Seeing your life’s work translate into reality is an indescribable feeling. However, the work isn’t done until we have an option for every single person waiting for an organ transplant.
Professor Muhammad Mohiuddin is the director of the xenotransplantation program at the University of Maryland Medical Center (USA), the mastermind of the first two heart transplants in the world from genetically modified pigs on humans.
Making xenotransplantations a normal therapy
With a very specific objective: to transform xenotransplantations into a routine therapy to save human lives. Starting from the next step, that of clinical studies. The two transplants completed, in fact, benefited from recognition as compassionate use therapies by the Food and Drug Administration (FDA, the US regulatory body)
We want to anticipate and begin human trials within two years or less,” he reveals, “based on our conversation with the FDA. Clinical trials may take a few years before gaining permission for regular use of this procedure.
A life of studies
Thanks to 33 years of research conducted by him, in 2022 his team at the University of Maryland transplanted a genetically modified pig heart into a patient suffering from a very serious heart disease for the first time in the world. Technically the organ graft was successful but David Bennett, the recipient, died after two months from a series of complications, also described in a publication in the prestigious scientific journal The Lancet.
Last September 23, the second transplant of a porcine heart with modified genes on Lawrence Faucette had completely different results from the beginning. Two days after the operation, in fact, the man was joking with the doctors and was able to sit on a chair.
What are your health conditions? Patient Faucette is well and is slowly improving — reports Mohiuddin — Her heart is functioning well, with no signs of rejection. still in hospital, but the plan is to send him home as soon as possible Posted by Nature Among the 10 people who have made the greatest contribution to science in 2022, the expert says he decided to dedicate himself to transplants because – he tells us – my mentor at university advised me to choose a field that would make a difference in patient survival.
Learn from mistakes
And the two xenotransplants carried out are proving him right. A long and uphill road, dotted with attempts, failures and new attempts. Each time learning from mistakes and adding a new piece. As in the case of the heart graft on Bennett which served to adjust the aim for the second.
What are the main differences between the two transplants? Pre-existing conditions. Bennett was on ECMO (extracorporeal blood circulation, ed.) with severe sarcopenia (loss of muscle mass, ed.), while Faucette entered the hospital with only a little breathlessness. He had a ventricular fibrillation arrest one day before admission. Bennett had surgical complications, but Faucette did not. The latter wears a pacemaker while Bennett does not.
Swine virus
Furthermore, it was only after the transplant last year that scientists discovered signs of a pig virus lurking in the heart and now have better tests to look for hidden viruses. They also learned to avoid certain medications. The second pig heart was no different from the first but, explains Mohiuddin, we ensured that the organ was not a carrier of any virus. And from a surgical point of view? No changes, except that with Faucette the surgery went smoothly, without surgical complications.
The next steps
What steps still need to be taken now? We must continue NHP (nonhuman primate) preclinical work to meet the criteria required by the FDA. In the meantime, we will continue to seek authorization for compassionate use. Also because competition in the sector is intense. Especially in the United States. Last year, surgeons at New York University Langone led by Professor Robert Montgomery, one of the pioneers in this field internationally, transplanted two more pig hearts. Two months ago the same team transplanted a genetically modified pig kidney that continued to function well after 32 days in a man declared dead according to neurological criteria (brain death) and maintained with a beating heart and ventilator support.
Accumulated preclinical data, sufficient to warrant the benefit
Professor Mohiuddin, however, believes he has gained a fair distance: We are proud of the preclinical data accumulated over the years – he underlines -, which distinguish us from other groups seeking similar authorizations as the FDA has in fact recognized twice. However, data generated at other centers could soon lead to licensure for other organs.
And if you ask him who will win in the race between human organ transplantation and xenotransplantation he answers without hesitation: At the moment the human organ has an advantage but in the future, with “personalized” pigs and organs on demand, pig organs will become a choice attractive.
October 29, 2023 (modified October 29, 2023 | 08:04)
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