A Nobel Prize–winning Osaka University team led by Shimon Sakaguchi achieves a world-first in mass-producing regulatory T cells, marking a breakthrough in autoimmune disease treatment.
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| Osaka University’s Shimon Sakaguchi, 2025 Nobel laureate, leads a team that achieves mass production of regulatory T cells—an advance that could transform global autoimmune therapy. Image: CH |
OSAKA, Japan — October 25, 2025:
In a discovery hailed as a potential game-changer in immunology, a research team led by Professor Shimon Sakaguchi of Osaka University has successfully developed a method to mass-produce regulatory T cells (Tregs)—a milestone that could transform how autoimmune diseases are treated around the world.
Sakaguchi, who will receive the 2025 Nobel Prize in Physiology or Medicine for his groundbreaking discovery of Tregs, described the advance as “the first step toward human application.” The announcement, reported by YS, marks a significant leap from theory to clinical potential in immune regulation science.
T cells normally defend the body by attacking viruses and bacteria. However, when they malfunction, they can target the body’s own tissues—triggering autoimmune disorders such as rheumatoid arthritis, type 1 diabetes, and lupus. Regulatory T cells act as the immune system’s “brakes,” preventing such self-destructive reactions.
For years, scientists have struggled to produce sufficient, stable, and functional Tregs for therapy. Sakaguchi’s team overcame this barrier by reprogramming inflammatory T cells taken from the blood of mice with autoimmune conditions. Using a proprietary two-week culture process, they converted many of these cells into stable Tregs while expanding their numbers exponentially.
When these lab-grown Tregs were administered to mice suffering from autoimmune colitis, inflammation was effectively suppressed. In another study involving bone marrow transplant–related inflammation, the 30-day survival rate jumped from below 25% to around 70% in treated mice.
“This is a major step toward developing cell-based therapies for autoimmune diseases,” Sakaguchi said. “We hope to apply this technology to a wide range of immune disorders.”
The Osaka University team plans to begin clinical trials in the United States next year to assess the safety and efficacy of Treg-based therapies in humans. In Japan, the first focus will be pemphigus vulgaris, a rare and currently incurable autoimmune skin disease causing severe blistering.
Professor Hiroshi Kawamoto, an immunologist at Kyoto University, praised the development, saying the Tregs produced by Sakaguchi’s method are “robust and practical for therapeutic use.” He added, “This could lay the foundation for next-generation immune treatments. It’s now time to confirm their effectiveness in humans.”
The advance represents more than just a new treatment—it signals a paradigm shift in medicine. Traditional therapies suppress immune activity broadly, often causing side effects. Treg therapy, in contrast, fine-tunes the immune response, restoring balance without compromising defense.
This move from immune suppression to immune engineering mirrors how CAR-T therapy revolutionized cancer treatment. If successful in humans, Sakaguchi’s innovation could bring the same transformation to autoimmune disease care, offering personalized, targeted immune restoration.
Osaka University also recognized Sakaguchi’s scientific contributions by awarding him the title of Distinguished Honorary Professor.
Sakaguchi’s breakthrough unites decades of fundamental immunology with cutting-edge biotechnology, positioning Japan at the forefront of cell-based immune therapy research. As trials begin, the world will watch closely to see if this achievement can deliver what medicine has long sought: a lasting cure for autoimmune disease through precision immune balance.