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Solid organ transplants are lifesaving but come with the burden of lifelong immunosuppression. That may soon change thanks to innovative new research in transplantation.

Nearly 40,000 transplants are performed each year in the United States, and the immunosuppression drugs that transplant recipients are required to take, although effective in preventing the rejection of the organ, are not without challenges.

“I’m taking 23 pills a day,” says Mary Baliker (pictured above), an author and healthcare professional who has been through four kidney transplants since she was diagnosed with proliferative glomerulonephritis at the age of nine. “At one point it was over 50. A lot of transplant recipients don’t want to complain about the side effects, but they’re real. And they’re serious.”

A lifetime of side effects

“Transplant care usually involves drugs that must be taken to suppress the immune system to prevent rejection,” explains Suzanne T. Ildstad, M.D., founder and chief scientific officer of Talaris Therapeutics Inc., a cell therapy company based in Boston, Massachusetts and Louisville, Kentucky. “What people don’t realize is that those same drugs can impair quality of life and shorten lifespan.”

These drugs can lead to numerous side effects that negatively impact the quality of life of transplant recipients, including increased susceptibility to infections, increased incidence of cancer and heart disease, and potential kidney damage.

“Immunosuppressant drugs are a necessary evil,” notes Joseph R. Leventhal, M.D., Ph.D., Fowler McCormick Professor of Surgery at Northwestern University’s Feinberg School of Medicine. “The challenge is that because of the limitations of the drugs, patients do not enjoy as long a transplant survival as they might.”

“It impacts me daily,” Baliker says. “I’ve had multiple skin cancers, and because I’ve been on medications that make me more susceptible to infection and healing, it takes longer for me to heal. Another consideration is the COVID vaccine in kidney transplant recipients. Unlike the general population, we need more than the recommended dosage. I do have antibodies after my third vaccine, but at a very minimal level. So, I still have to be very careful.”

Innovation is needed

After a lifetime of living with the effects of immunosuppressant drugs, Baliker advocates for more innovative solutions. “The transplant community as a whole — we need more innovation, we need more support and better treatments,” she says.

Dr. Ildstad agrees. “There really haven’t been any major breakthroughs with respect to new drugs that have fewer complications,” she says. Talaris is investigating FCR001, an innovative cell therapy, in 2 clinical trials (FREEDOM-1 and FREEDOM-2) with the goal of patients discontinuing chronic immunosuppression.

“We do a combined kidney and stem cell transplant where we collect stem cells from the donor a few months before the living donor kidney transplant, and then donor cells are processed to create FCR001,” explains Dr. Leventhal. “The recipient then goes through a regimen known as ‘conditioning’ to successfully receive those stem cells.”

“The stem cell in your body produces a lot of the immune cells that protect you from infection,” adds Dr. Ildstad. “When you transplant the stem cell from the donor into the recipient, it essentially re-educates the recipient to see the donor as part of themselves. This is called inducing tolerance.”

For Baliker, such innovative approaches offer hope for improved quality of life. “I always say my transplant isn’t my life — transplants are a part of my life,” she says. “It’s important to promote organ donation — to explain that it works and can give quality of life to patients. But we really need more innovation because being immune-compromised affects every aspect of your life.”

To learn more about Talaris, visit Talaristx.com.

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