Status:
RECRUITING
DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
Lead Sponsor:
Direct Biologics, LLC
Conditions:
Perianal Fistula Due to Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment...
Eligibility Criteria
Inclusion
- Written informed consent from participant
- Men and women 18-75 years of age with a diagnosis of Crohn's Disease for at least six months duration prior to Day 1
- Single and/or multi-tract perianal fistula(s) with 2 or fewer openings, that are actively draining
- Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab), or small molecule inhibitors (tofacitinib, upadacitinib)
- Previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula
- Medical therapy for CD stable for at least 2 months prior to Day 1 (Changes in dosing or dosing intervals related to serum drug levels are not permitted)
Exclusion
- Lack of informed consent
- Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding
- A participant who is unwilling to use medically acceptable contraception methods during participation in study
- Active perianal abscess or infection at screening or Day 1
- Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant
- Confirmed HIV, Hepatitis B, or Hepatitis C infections
- History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening
- History of colorectal cancer within 2 years of screening
- Use of investigational therapy or treatment within 30 days prior to Day 1
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06918808
Start Date
May 19 2025
End Date
October 31 2026
Last Update
June 15 2025
Active Locations (1)
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1
Columbia University Irving Medical Center/NYPH
New York, New York, United States, 10032