Exosome Evidence Index

Conditions / Lungs and kidneys

Exosomes for lung disease in premature infants

One trial, reported on a registry, was stopped after a serious bowel complication in a premature infant.

No exosome product is FDA-approved for this or any other condition.

1 study, strongest design first

How to read the bars and marks

Bars: how strong the study design is

More filled bars means a design that can tell more reliably whether the treatment caused the result.

  • Single case or case seriesOne patient or a handful, described without a comparison. It can raise an idea; it cannot show that a treatment works.
  • Study without a control groupA group was treated and followed, but nobody was left untreated for comparison. Improvement may come from time, other care, or the placebo effect.
  • Controlled trialTreated patients were compared with a control: placebo, another treatment, or the untreated side of the face. Most exosome trials at this level are small and short.
  • Phase 3 resultsA large trial designed to prove a treatment works, the kind regulators usually require. No exosome product has published phase 3 results.
  • FDA approvedThe FDA has reviewed the evidence and approved the product for that use. No exosome product is approved for any use.

Marks: what the study found

A solid mark means a benefit over the comparison. Hollow or partly filled marks mean less.

  • Better than controlThe treated group did better than the comparison group on the main measures.
  • Mixed or short-lived resultSome benefit, but only on some measures, in a subgroup, or for a short time.
  • Similar to comparison treatmentAbout the same as another treatment, such as PRP, which may itself be unproven.
  • No benefit over controlThe treated group did no better than placebo or the comparison.
  • Improvement reported, no control groupPatients improved, but without a comparison group there is no way to tell whether the treatment caused it.
  • Safety onlyThe study looked for harms. It was not designed to show whether the treatment works.
  • Stopped for a safety eventThe study was halted after a serious problem in a participant.

More on how studies are graded

  1. Stopped for a safety eventStrength of design, level 2 of 5: Study without a control group

    IV stem cell vesicles (UNEX-42) for premature infants at high risk of chronic lung disease

    United Therapeutics, ClinicalTrials.gov NCT03857841. Stopped in the lowest-dose group. Made from: stem cells, tissue not specified here.

    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.