A recent Phase 1 clinical trial tested whether giving repeated doses of umbilical cord-derived-MSCs is safe for very premature babies at high risk of BPD (1). Ten infants received three weekly MSC infusions starting about two weeks after birth. All babies completed the treatment and were later discharged, with no serious side effects reported during their hospital stay or over a two-year follow-up. These results suggest that multiple MSC doses are feasible and safe, though more research is needed to determine if they improve lung development.

Along with our HULC-1 trial, which showed that a single MSC dose is safe, this study shows that repeated doses are also well-tolerated.

Together, these findings have paved the way for our HULC-2 clinical trial to evaluate the safety and potential benefits of repeated MSC treatments for premature infants with BPD.