Actively Recruiting
A Phase 2a Study of Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product (DB-3Q) in Patients With Perianal Fistulizing Crohn's Disease
Led by Direct Biologics, LLC · Updated on 2026-05-15
36
Participants Needed
5
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of increasing doses of DB-3Q, a biological treatment derived from bone marrow mesenchymal stem cells, for adults with Perianal Fistulizing Crohn's Disease. This is a phase 2a, double-blind, randomized, placebo-controlled clinical trial sponsored by Direct Biologics, LLC, aiming to better understand treatment impact on this challenging condition. Participants will receive a single dose of DB-3Q or placebo, administered either as a 15 mL or 30 mL direct injection, or a combination of 15 mL intravenous and 30 mL direct injection. The study uses a sequential cohort design with escalating doses to assess different treatment levels. Placebo groups receive matching saline injections. The trial includes several groups to compare these dosing approaches under tightly controlled conditions. During the study, participants undergo screening including pelvic MRI reviewed by a central radiologist to confirm fistula characteristics. Researchers assess combined remission rates at 12 and 24 weeks to measure treatment response. Safety and efficacy are closely monitored throughout the trial, with follow-up visits and evaluations planned to track participant progress over time. The study runs until the end of 2027 and involves adults aged 18 to 75 with active fistulas despite prior therapies.
CONDITIONS
Brief 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 one or two perianal fistulas with one or two external openings that are actively draining
- Have failed at least one medical therapy in the past year, such as antibiotics, immunomodulators, monoclonal antibodies, or small molecule inhibitors
- Have had previous failed surgical intervention or are not candidates or willing to undergo surgery for their fistula
- Have stable Crohn's Disease medical therapy for at least 2 months before Day 1
- Have stable antibiotic treatment for at least 2 weeks before Day 1
- Have used oral corticosteroids of 20 mg/day prednisone or less, stable for at least 4 weeks before Day 1
- Have an approved screening pelvic MRI reviewed by a central radiologist meeting study imaging criteria
- Meet radiologic inclusion criteria confirming specific fistula anatomy and imaging scores
You will not qualify if you...
- Lack of informed consent
- Pregnant or breastfeeding women, or women of childbearing potential without a negative pregnancy test
- Unwillingness to use acceptable contraception during the study
- Active perianal abscess or infection at screening or Day 1
- Significant medical conditions within 6 months before Day 1 that may affect safety
- Confirmed HIV, Hepatitis B, or Hepatitis C infection
- History of cancer (except localized non-melanoma skin cancer) within 1 year
- History of colorectal cancer within 2 years
- History of coagulation disorders or current anticoagulant therapy
- Presence of recto/ano-vaginal fistula
- Presence of ileal anal pouch or history of proctectomy
- Severe proctitis
- Conditions preventing safe MRI evaluation, such as MRI unsafe devices or claustrophobia
- Abnormal lab results outside specified ranges at screening
- Use of investigational therapy within 30 days before Day 1
- Not meeting radiologic anatomic or imaging endpoint criteria for fistula
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive a single dose of DB-3Q or placebo by direct injection and/or intravenous infusion.
Multiple visits including baseline and follow-up assessments during treatment
Trial Site Locations
Total: 5 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
4
Direct Biologics Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
Direct Biologics Investigational Site
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
E
Executive Vice President, Clinical Affairs, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here