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Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease

NCT05130983 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-02-11

No results posted yet for this study

Summary

Protocol Summary

* Title: A Phase I study of ExoFlo, an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product, for the treatment of medically refractory Crohn's disease.
* Short Title: ExoFlo for Crohn's Disease
* Phase: 1
* Methodology: Open label
* Study Duration: 24 months
* Subject Participation: 58 weeks
* Single or Multi-Site: Multi-Site

Conditions

  • Crohn Disease
  • Inflammatory Bowel Diseases

Interventions

BIOLOGICAL

ExoFlo

Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

Sponsors & Collaborators

  • Direct Biologics, LLC

    lead INDUSTRY

Principal Investigators

  • Bill Arana · Direct Biologics, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2024-12-01
Completion
2024-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05130983 on ClinicalTrials.gov