Actively Recruiting
DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
Led by Direct Biologics, LLC · Updated on 2026-02-23
36
Participants Needed
3
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 of Perianal Fistulizing Crohn's Disease.
CONDITIONS
Official Title
DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Men and women aged 18 to 75 years
- Diagnosed with Crohn's Disease for at least six months before Day 1
- Have single or multiple perianal fistulas with two or fewer openings that are actively draining
- Have failed at least one medical therapy for Crohn's Disease in the past year
- Have had previous failed surgical intervention for fistula management or are not candidates or unwilling to have surgery
- Have had stable medical therapy for Crohn's Disease for at least two months before Day 1 with no dosing changes related to drug levels
You will not qualify if you...
- Lack of informed consent
- Pregnant, breastfeeding, or women of childbearing potential without a negative pregnancy test
- Unwilling to use acceptable contraception during the study
- Active perianal abscess or infection at screening or Day 1
- Significant medical conditions within six months before Day 1 that may affect safety
- Confirmed HIV, Hepatitis B, or Hepatitis C infection
- History of cancer including melanoma (except localized non-melanoma skin cancers) within one year before screening
- History of colorectal cancer within two years before screening
- Use of investigational therapies within 30 days prior to Day 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Direct Biologics Investigational Site
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Direct Biologics Investigational Site
St Louis, Missouri, United States, 63130
Actively Recruiting
3
Columbia University Irving Medical Center/NYPH
New York, New York, United States, 10032
Actively Recruiting
Research Team
E
Executive Vice President, Clinical Affairs, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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