UW Hospital plans to launch the first study in the country of a cell therapy for a potentially serious complication of kidney transplants, the most common type of organ transplant.
Doctors will infuse donor immune cells into kidney recipients who develop severe infections of cytomegalovirus, or CMV. The virus, generally mild in most people, can become dangerous in patients whose immune systems are suppressed, such as patients who take drugs to prevent rejection of donor organs.
In kidney transplant recipients, CMV can damage the brain, lungs, gut and kidneys, said Dr. Arjang Djamali, chief of kidney medicine at UW Health. Antiviral drugs to treat the infection don’t always work and can have side effects, such as reducing blood counts and kidney function, Djamali said.
In the phase 1 trial scheduled to start at UW Hospital later this year, doctors will collect T cells from a matched donor who has been exposed to CMV, and expand the cells in a lab run by the UW Program for Advanced Cell Therapy, or PACT.
The cells, trained by the donor’s immune system to target CMV, will be given to the kidney recipient to fight the infection. The cell donor could be the same person who donated the kidney, if it was a living donor transplant, or a relative or other person who is well-matched.
“We hope to have found a solution with cell therapy,” said Djamali, who designed the study with Dr. Jacques Galipeau, PACT director.
If the trial involving 20 patients is successful, the doctors plan to expand the study to more centers and more participants, eventually including recipients of other organs, Djamali said.
A similar study at UW Hospital is set to test the cell therapy in patients who receive bone-marrow, or stem-cell, transplants.
UW Hospital, one of the nation’s largest transplant centers, does nearly 300 kidney transplants a year.
About a third of kidney recipients develop a CMV infection, and it’s severe for about a third of them , Djamali said. Some acquire CMV from the donor organ or in other ways after the transplant. But in most, a previous infection is reactivated after they start immune suppression drugs to accept the donor kidney, he said.
The trial will test three doses of cell therapy. “We are hoping to find the right dose in terms of safety and efficacy,” Djamali said.