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Sponsor kills ExoFlo perianal fistula trial after enrolling five patients

Author: Andrew Jonathan Hillman (ORCID 0009-0001-5396-321X)
Published: , Zenodo. Also published in The Hillman Letter.
DOI: 10.5281/zenodo.23352288 (all versions); this version 10.5281/zenodo.23352289
License: CC BY 4.0

Abstract

Reports the August 2026 termination of a Phase 1/2 trial of an investigational bone marrow MSC-derived extracellular vesicle product in Crohn's-associated perianal fistula (NCT05836883) after five subjects enrolled. Notes the stated reason was enrollment challenges and places it alongside earlier terminations by the same sponsor.

Exosome, stem cell and extracellular vesicle products discussed here are not approved by the FDA for any indication. This essay describes regulatory and public records. It does not describe an available treatment, and it is not legal advice.

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Indexed in OpenAlex under author A5139488776.

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