CHA Biotech’s stem cell therapy triggers menstruation return in phase 1

CHA Biotech has posted phase 1 data on its stem cell therapy for premature ovarian insufficiency (POI), pointing to safety and early signs of ovarian function recovery -- including one patient who resumed menstruation after years of amenorrhea.

The Korean company on Wednesday shared topline results from a single-arm study of CBT210-POI, branded as CordSTEM-ST, in six women aged 25 to 39 with POI, a condition that affects about one percent of women under 40 and often leads to infertility.

The therapy, delivered as a one-time intravenous infusion, was generally well tolerated, with no severe adverse events reported.

Across the cohort, 21 adverse events were reported. CHA Biotech said more than 90 percent were mild, with vaginal discharge and muscle pain among the most common. One serious event, a mild infusion reaction considered “possibly related” to treatment, resolved without complications. No deaths or severe events were observed.

Early biological changes tracked with ovarian activity. One patient who hadn’t menstruated since her POI diagnosis began bleeding again at week 18 post-treatment, the company said. Another developed a mature follicle by week 24, a marker of ovarian function that had been absent at baseline.

Others showed reductions in follicle-stimulating hormone, increases in estradiol, and thickening of the endometrial lining -- indicators the company described as evidence of “early therapeutic potential.”

The trial was conducted at CHA Bundang Medical Center, with CHA Biotech expecting to complete the clinical study report in the third quarter to guide future studies, including in Japan.

“As the average age of childbirth rises, ovarian decline is becoming a leading cause of infertility in Korea,” said Nam Su-youn, chief scientific officer and chief technology officer at CHA Biotech, in a statement Wednesday.

She noted that while estrogen-based hormone therapy remains the standard approach, “long-term hormone use has been linked to increased risks of breast cancer, cardiovascular disease, and stroke,” reinforcing the need for safer alternatives.

Nam added that the program could extend beyond POI, contributing to broader challenges tied to low birth rates and aging populations.