Studies / Lung disease in premature infants
IV stem cell vesicles (UNEX-42) for premature infants at high risk of chronic lung disease
United Therapeutics, ClinicalTrials.gov NCT03857841
Stopped for a safety eventRegistry results
Stopped for a safety event: The study was halted after a serious problem in a participant.
Level 2 of 5: A group was treated and followed, but nobody was left untreated for comparison. Improvement may come from time, other care, or the placebo effect.
See the full key- Design
- Dose-escalation safety trial
- People
- Stopped in the lowest-dose group
- Made from
- Stem cells, tissue not specified here
- How it was given
- IV infusion
What they found
The trial was stopped after one of the two infants in the lowest-dose group developed necrotizing enterocolitis, a serious bowel complication. A 2025 review describes the event as fatal.
What limits it
Reported on a trial registry rather than in a peer-reviewed paper. Necrotizing enterocolitis is a known complication of extreme prematurity, so a link to the product is not established.