DB-3Q extracellular vesicle therapy for perianal Crohn's fistulas
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
This Phase 2 test uses DB-3Q, a treatment made from bone marrow mesenchymal stem cell-derived extracellular vesicles, to see if it can heal active perianal fistulas in adults with Crohn's disease who haven't responded to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Direct Biologics, LLC Industry-sponsored |
| Drugs / interventions | adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab, tofacitinib, upadacitinib, methotrexate |
| Locations | 3 sites (Aurora, Colorado and 2 other locations) |
| Trial ID | NCT06918808 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized, placebo-controlled, sequential-cohort, ascending-dose Phase 2 trial comparing DB-3Q to placebo in adults with active draining perianal fistulas due to Crohn's disease. Participants will be assigned to increasing dose cohorts and receive either DB-3Q or placebo under blinded conditions to monitor safety and signs of fistula healing. Eligible patients must have had Crohn's disease for at least six months, draining fistulas with two or fewer openings, prior failure of medical therapy or surgery, and stable background Crohn's medications before dosing. The trial is being conducted at multiple U.S. sites with scheduled follow-up visits to document adverse events and fistula outcomes.
Who should consider this trial
Good fit: Adults 18–75 years old with Crohn's disease for at least six months who have actively draining single- or multi-tract perianal fistulas with two or fewer openings and who have failed prior medical and/or surgical treatments are the intended candidates.
Not a fit: Patients with more than two external openings, non-draining or completely healed fistulas, recent changes in Crohn's medications, or other contraindications are unlikely to qualify and may not receive benefit from this protocol.
Why it matters
Potential benefit: If successful, DB-3Q could promote closure of perianal fistulas and reduce the need for additional surgery or prolonged high-risk medical therapy.
How similar studies have performed: Local injections of mesenchymal stromal cell therapies have shown benefit for refractory perianal Crohn's fistulas in prior trials, but use of bone marrow MSC-derived extracellular vesicles (EVs) is a newer, less-tested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written informed consent from participant 2. 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 3. Single and/or multi-tract perianal fistula(s) with 2 or fewer openings, that are actively draining 4. 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) 5. 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 6. 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 Criteria: 1. Lack of informed consent 2. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding 3. A participant who is unwilling to use medically acceptable contraception methods during participation in study 4. Active perianal abscess or infection at screening or Day 1 5. Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant 6. Confirmed HIV, Hepatitis B, or Hepatitis C infections 7. History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening 8. History of colorectal cancer within 2 years of screening 9. Use of investigational therapy or treatment within 30 days prior to Day 1
Where this trial is running
Aurora, Colorado and 2 other locations
- Direct Biologics Investigational Site — Aurora, Colorado, United States (Recruiting)
- Direct Biologics Investigational Site — St Louis, Missouri, United States (Recruiting)
- Columbia University Irving Medical Center/NYPH — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Executive Vice President, Clinical Affairs, MS
- Email: clinicalaffairs@directbiologics.com
- Phone: 1-800-791-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.