Studies / Complex anal fistula
Placental stem cell exosomes injected into complex anal fistulas (without Crohn's disease)
Pak H et al., Journal of Gastroenterology and Hepatology, 2023
Improvement reported, no control group
Improvement reported, no control group: Patients improved, but without a comparison group there is no way to tell whether the treatment caused it.
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
- Phase I, no control group
- People
- 11 people
- Made from
- Placenta
- How it was given
- Injected during surgery
What they found
10 of 11 patients showed improvement on physical examination, and the authors reported the treatment as safe.
What limits it
No comparison group, and fistulas were treated in the operating room, so surgery alone may explain some improvement. A randomized trial against fistulotomy alone has been registered (NCT06568653).