deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 6-arm NCT05836883

Study of ExoFlo for the Treatment of Perianal Fistulas

A Phase IB/IIA Study of ExoFlo, an Ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Perianal Fistulizing Crohn's Disease

Sponsor: Direct Biologics, LLC

Updated 7 times since 2023 Last updated: Feb 7, 2025 Started: Aug 28, 2023 Primary completion: Dec 1, 2024 Completion: Dec 1, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Enrollment challenges.

Other terminated trials from Direct Biologics, LLC

More terminations from Direct Biologics, LLC

Listed as NCT05836883, this PHASE1/PHASE2 trial focuses on Crohn's Disease and Perianal Fistula and remains terminated or withdrawn. Sponsored by Direct Biologics, LLC, it has been updated 7 times since 2023, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jun 2023 – ~Oct 2023 · 4 months · monthly snapshotNot Yet Recruiting~Oct 2023 – ~Mar 2024 · 5 months · monthly snapshotRecruiting~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshotRecruiting~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshotActive Not Recruiting~Mar 2025 – present · 18 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Mar 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

    Status: Active Not RecruitingTerminated

  2. Sep 2024 — Mar 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  3. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Status: RecruitingActive Not Recruiting

  4. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  5. Mar 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

Show 2 earlier versions
  1. Oct 2023 — Mar 2024 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet RecruitingRecruiting

  2. Jun 2023 — Oct 2023 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Direct Biologics, LLC
Data source: Direct Biologics, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations