Can stem cell vesicles heal Crohn's fistulas?
NCT ID NCT05836883
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This early-phase trial tests whether ExoFlo, a product made from extracellular vesicles derived from donor bone marrow stem cells, can safely treat perianal fistulas in people with Crohn's disease. The study enrolls adults aged 18-75 who have had Crohn's for at least six months and have failed at least one prior medical therapy. Participants receive a local injection of ExoFlo or a placebo, and the main goal is to assess safety and feasibility.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- ExoFlo, an injection of extracellular vesicles derived from donor bone marrow stem cells
- What this could lead to
- If safe and effective, ExoFlo could offer a new way to heal perianal fistulas in Crohn's disease, potentially reducing the need for surgery or long-term immune-suppressing drugs.
- What could go wrong
- This is a very early, small trial (only 5 participants) focused on safety and feasibility, so it may not show clear benefit. Risks include injection-site reactions or lack of effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Direct Biologics Investigational Site
Los Angeles, California, 90048, United States
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