A life transformed
Nursing assistant Kimberly Renihan was a 22-year-old newlywed when a lupus diagnosis flipped her life’s script. It explained her crushing fatigue, joint pain and hair loss, but effective treatment was elusive. She gave up her dream of becoming a nurse.
The chronic autoimmune disease, which affects 1.5 million Americans, causes the immune system to attack the body’s own tissues. Lupus is nine times more common in women, often striking between ages 15 and 45. It can flare up periodically over the years, and there is no cure.
An unexpected pregnancy a year after her diagnosis in 2006 exacerbated Renihan’s disease, which now attacked her kidneys. The UCI Health high-risk maternity team hospitalized her at 24 weeks to manage her symptoms and preserve the pregnancy.
Five weeks later, doctors said her son would have a better shot outside the womb. Owen Renihan was born July 1, 2008. At 29 ounces, he was the size of a soda can.
One of the rheumatologists managing her lupus symptoms during the pregnancy was Dr. Sheetal Desai. With her help, Renihan’s kidney disease (called lupus nephritis) went into remission a few months after Owen’s birth.
Flare-ups and fatigue
Desai has remained her steadfast guide through periods of stability and severe flare-ups.
In 2020, lupus launched another brutal attack on her kidneys. Multiple therapies, including low-dose chemotherapy, lost effectiveness over time. Overwhelmed by fatigue and pain, her health declined until she was barely able to function more than four to six hours a day.
At one appointment, Desai pulled out a list of all medications approved for lupus, even those that could be used off-label.
“We checked off every single one I had tried,” Renihan says. “There were none left.”
Novel stem-cell therapy
That’s when Desai told her about a phase 1 clinical trial for an investigational stem-cell therapy called FT819, which has shown promise in preclinical trials for lupus and other autoimmune diseases.
“It’s a very new and promising approach that I think it is definitely worth trying,” Desai told her.
Unlike traditional lupus treatments that suppress the entire immune system, FT819 is a one-time infusion of bioengineered chimeric antigen receptor (CAR) T cells. Created in a lab, the modified cells are designed to seek and eliminate only the B cells driving the disease.
What makes the therapy so promising, Desai says, is that “we’re using a highly targeted approach to direct the immune system to clean up shop with the hope of creating an immune reset.”
First clinical trial participant
As the first UCI Health trial participant, Renihan in late August underwent a 25-minute infusion of the cell therapy developed by Fate Therapeutics. No longer on other lupus medications, she began noticing subtle changes.
About five weeks later, the crushing fatigue lifted. She started exercising, resumed playing piano and tackling everyday activities. Best of all, she could attend her now 17-year-old son’s school events.
“I’m picking up my son, going to the store, cooking dinner,” she says. “Finally taking my place back at the family table has been so wonderful.”
Tests show her kidney function has improved significantly. Now, several months post-infusion, she is hopeful.
Profound joy and new hope
“After 20 years, you don’t let yourself get too excited — I’ve been disappointed so many times,” says Renihan, now 41. “But I cannot deny the differences I’m seeing and feeling.”
For Desai, witnessing Renihan’s transformation after nearly two decades is a moment of profound joy — one she cannot describe without tearing up.
“I was so invested in finding a therapy that would work for her,” says Desai, a professor and chief of rheumatology at the UC Irvine School of Medicine.
“The day she got her CAR T infusion, I went home and cried. I was so excited to be able to offer this to her. To see her now living her life to the fullest has been the greatest gift.”
For Renihan, each new day brings joys she hadn’t dared to imagine, especially quality time with her husband and son, now a high school senior and long-distance runner. They are even planning trips to Japan and Australia.
“For 20 years, your brain tells you, ‘I’m sick,’” she says. “It’s a hard transition to think I’m healing. It’s like being released from prison. You’ve been living this life for so long, and all of a sudden the doors open and your body says, ‘You’re free!’”
Trial open to other lupus patients
Desai is working to identify other lupus patients who haven’t been helped by conventional therapies for the trial at the UCI Alpha Clinic, one of only five California sites to offer the therapy.
The trial is funded by the California Institute of Regenerative Medicine and will be monitored for two years to evaluate its long-term safety and efficacy.
Those interested in the trial can view details and eligibility requirements online.