ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Perianal fistulas are a serious complication of Crohn’s disease and can be hard to treat. This trial tested a novel extracellular-vesicle therapy (ExoFlo) delivered locally as a potential new option, so patients with perianal disease and their clinicians may want to know about the research landscape.
Who Should Pay Attention
Patients with Crohn’s disease and perianal fistulas; caregivers; gastroenterologists and colorectal surgeons; researchers studying cell-derived or biologic therapies for fistulizing disease.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 1, Phase 2
Enrollment5 participants
Study statusTerminated
Source depthTrial registry record
What To Know
This is a ClinicalTrials.gov record for a phase IB/IIA randomized, placebo-controlled, dose-escalation study testing ExoFlo — bone marrow mesenchymal stem cell–derived extracellular vesicles — given as a local injection to treat perianal fistulizing Crohn’s disease.
The trial planned a 2:1 randomization (ExoFlo vs saline) in small cohorts with adverse events as a primary outcome and was registered as terminated. The trial enrolled adults (18–75) with Crohn’s disease and single or multi-tract perianal fistulas who had failed prior medical and/or surgical therapy.
Key exclusion criteria included active perianal abscess, recent cancer, rectovaginal fistula, severe proctitis, or inability to undergo MR evaluations. Study sites included Direct Biologics in Los Angeles.
Because the record shows the registry status as TERMINATED and this is an interventional early-phase trial, the entry reports design and eligibility but does not present trial results.
Keep In Mind
This is a ClinicalTrials.gov trial record (phase IB/IIA, interventional) registered by Direct Biologics; the status is listed as TERMINATED and no trial results are provided in the record. The entry describes design, eligibility, and planned outcomes but not findings.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorDirect Biologics, LLC
Trial IDNCT05836883
Study typeInterventional
Trial phasePhase 1, Phase 2
Enrollment5 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 11, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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