Conditions / Lungs and kidneys
Exosomes for covid-19 lung disease and inhaled use
The most studied area. A phase 2 trial of ExoFlo found lower mortality only at the higher dose and in a younger subgroup, and a phase 3 trial is underway. The other studies are small, uncontrolled, or test safety only.
Phase 3 EXTINGUISH ARDS trial of ExoFlo (NCT05354141), expanded to ARDS from any cause; no results found as of October 2026.
No exosome product is FDA-approved for this or any other condition.
5 studies, 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.
- Mixed or short-lived result
Bone marrow stem cell vesicles (ExoFlo) for respiratory failure from COVID-19
Lightner AL et al., CHEST, 2023. 102 people. Made from: bone marrow.
No treatment-related adverse events. Lower 60-day mortality was seen in the higher-dose group and in a subgroup of patients aged 18 to 65.
- No benefit over control
Stem cells with or without added vesicles for COVID-19 ARDS
Zarrabi M et al., Stem Cell Research & Therapy, 2023. 43 analyzed (8 got cells plus vesicles). Made from: umbilical cord.
Both treated groups had lower inflammatory markers than the control group, with no serious adverse events. A 2025 review of the trial reports no significant difference between cells alone and cells plus vesicles.
- Safety only
Inhaled adipose stem cell vesicles in healthy volunteers
Shi M et al., Journal of Extracellular Vesicles, 2021. 24 healthy volunteers. Made from: fat (adipose) stem cells.
All doses were well tolerated. Two people had a brief, mild slowing of heart rate that was not linked to dose.
- Improvement reported, no control group
Bone marrow stem cell exosomes (ExoFlo) for severe COVID-19
Sengupta V et al., Stem Cells and Development, 2020. 24 people. Made from: bone marrow.
Oxygen levels, clinical status, and lab markers improved, survival was 83%, and no adverse events were seen within 72 hours.
- Improvement reported, no control group
Inhaled adipose stem cell exosomes for severe COVID-19
Zhu Y et al., Stem Cell Research & Therapy, 2022. 7 people. Made from: fat (adipose) stem cells.
All patients tolerated treatment. Lymphocyte counts rose slightly, and lung lesions on CT regressed to varying degrees.