Perianal Fistula Due to Crohn's DiseasePhase 2NCT06918808
DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
A Phase 2 study testing DB-3Q in people with Perianal Fistula Due to Crohn's Disease, run by Direct Biologics, LLC at 5 sites in United States.
Trial 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 of Perianal Fistulizing Crohn's Disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Perianal Fistula Due to Crohn's Disease
- What is being tested?
- DB-3Q
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 May 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- One or two perianal fistula(s) with 1 or two external 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)
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- Antibiotics for the treatment of CD (e.g., ciprofloxacin, metronidazole, or rifaximin) must have been stable for at least 2 weeks prior to Day 1
- Oral corticosteroids ≤ 20 mg/day prednisone or its equivalent and must have been stable for at least 4 weeks prior to Day 1
- Approval of a screening pelvic MRI by review of a central radiologist. The definition of an acceptable screening pelvic MRI is provided in the study imaging manual.
- Fulfillment of radiologic inclusion by a central radiologist. Radiologic inclusion on MRI is presence of 1 or 2 qualifying perianal fistula(s). Radiologic inclusion assesses anatomic criteria of a perianal fistula and study-defined imaging endpoint criteria. a. Anatomically, a qualifying perianal fistula on MRI fulfills the following from central radiologist assessment: i. has a communication with the internal sphincter of the anal canal ii. is classified as a Parks intersphincteric, transsphincteric, or suprasphincteric perianal fistula. b. For study imaging endpoints, a central radiologist confirms that a fistula has a minimum score of 7 (range 0 to 25) on MAGNIFI-CD and a fistula fibrosis -to-fluid ratio of less than 80%.25, 37 Within components of MAGNIFI-CD, the fistula has a length of 2.5 cm or greater and has a composition of either 'predominantly fluid/pus' or 'predominantly granulation tissue'. c. Within components of fistula fibrosis-to-fluid ratio, the ratio of hypointense scarring or fibrosis on MRI T2 weighted sequences to hyperintense fluid on MRI T2 weighted sequences is below 80%.25 The fistula is categorized into one of following ranges of fibrosis-to- fluid ratio: i) 0%, ii) 1-19%, iii) 20-39%, iv) 40-59%, or v) 60-79%
Who cannot join
- 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
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- 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
- History of coagulation disorders and/or are currently on anti- coagulant therapy
- Presence of a recto/ano-vaginal fistula
- Presence of an ileal anal pouch and/or history of proctectomy
- Presence of severe proctitis (SES CD >6)
- Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for participant to undergo MRI evaluations (i.e., presence of implantable or external MRI unsafe device that cannot be removed, body weight exceeding limitations, claustrophobia, etc.)
- The following out of range laboratory results at screening
- WBC > 13 x 109 /L
- Hemoglobin < 8 g/dL
- Platelet count < 100,000/mL
- AST/ALT > 3 times the upper limit of normal
- Creatinine > 2 μmol/L
- PT/INR: 2 times the upper limit of normal
- Hemoglobin A1c > 6.5 mg/dL
- Use of investigational therapy or treatment within 30 days prior to Day 1
- Does not meet the radiologic anatomic inclusion criteria: i) has a primary communication with the rectum and not the anal canal; ii) is classified as a Parks extrasphincteric fistula
- Does not meet the minimum thresholds for the radiologic imaging endpoint inclusion criteria: i) has a MAGNIFI-CD score of <7 (range 0-6) on screening pelvic MRI; ii) has a fibrosis-to-fluid ratio of 80% or more (range 80-100%) on screening pelvic MRI
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Executive Vice President, Clinical Affairs, MS contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Direct Biologics Investigational Site
Aurora, Colorado, 80045
- Recruiting
Direct Biologics Investigational Site
Nashville, Tennessee, 37232
- Recruiting
Columbia University Irving Medical Center/NYPH
New York, New York, 10032
Claudia Musat, cm2065@cumc.columbia.edu
- Recruiting
Direct Biologics Investigational Site
Philadelphia, Pennsylvania, 19104
- Recruiting
Direct Biologics Investigational Site
St Louis, Missouri, 63130
About this study
Official title: 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 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
- Perianal Fistula Due to Crohn's Disease
- Being tested
- DB-3Q, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB-3QBiological
DB-3Q (IMP) is the frozen liquid formulation of acellular secretome proteins and extracellular vesicles isolated from human bmMSC and processed under current Good Manufacturing Process standards.
PlaceboBiological
0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Single dose DB-3Q 15 mL direct injection | Experimental | Not described Receives: Biological: DB-3Q |
| Single dose Placebo 15 mL direct injection | Placebo comparator | Not described Receives: Biological: Placebo |
| Single dose DB-3Q 30 mL direct injection | Experimental | Not described Receives: Biological: DB-3Q |
| Single dose Placebo 30 mL direct injection | Placebo comparator | Not described Receives: Biological: Placebo |
| Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injection | Experimental | Not described Receives: Biological: DB-3Q |
| Single dose Placebo 15 ml IV and Placebo 30 mL direct injection | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Remission
Clinically confirmed 100% closure of all treated external openings, without development of new fistulas or abscesses and drainage > 1 cm by the external openings, occurring spontaneously or after gentle finger compression; and on blinded central review of the MRI results, combined imaging endpoint of >50% reduction in MAGNIFI-CD score and >20% increase in perianal fistula fibrosis-to-fluid ratio.
Measured: 24 Weeks
Secondary outcomes (1)
Combined Remission
Clinically confirmed 100% closure of all treated external openings, without development of new fistulas or abscesses and drainage > 1 cm by the external openings, occurring spontaneously or after gentle finger compression; and on blinded central review of the MRI results, combined imaging endpoint of >50% reduction in MAGNIFI-CD score and >20% increase in perianal fistula fibrosis-to-fluid ratio.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start19 May 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal Fistula Due to Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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 PFCD.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direct Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918808
- Sponsor's protocol ID
- 3Q-PFCD-201
- Status last verified
- Feb 2026
- First submitted
- 2 Apr 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IP protection
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06918808
- Acronym / sponsor ID
- 3Q-PFCD-201
- Conditions
- Perianal Fistula Due to Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Direct Biologics, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 May 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- 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 PFCD.
| Arm | Type | Receives |
|---|---|---|
| Single dose DB-3Q 15 mL direct injection | Experimental | Biological: DB-3Q |
| Single dose Placebo 15 mL direct injection | Placebo comparator | Biological: Placebo |
| Single dose DB-3Q 30 mL direct injection | Experimental | Biological: DB-3Q |
| Single dose Placebo 30 mL direct injection | Placebo comparator | Biological: Placebo |
| Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injection | Experimental | Biological: DB-3Q |
| Single dose Placebo 15 ml IV and Placebo 30 mL direct injection | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- One or two perianal fistula(s) with 1 or two external 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DB-3QDB-3Q (IMP) is the frozen liquid formulation of acellular secretome proteins and extracellular vesicles isolated from human bmMSC and processed under current Good Manufacturing Process standards. | Biological | Single dose DB-3Q 15 mL direct injection, Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injection, Single dose DB-3Q 30 mL direct injection |
| Placebo0.9% NaCl | Biological | Single dose Placebo 15 mL direct injection, Single dose Placebo 15 ml IV and Placebo 30 mL direct injection, Single dose Placebo 30 mL direct injection |
Primary outcome
Combined Remission
Time frame: 24 Weeks
Clinically confirmed 100% closure of all treated external openings, without development of new fistulas or abscesses and drainage > 1 cm by the external openings, occurring spontaneously or after gentle finger compression; and on blinded central review of the MRI results, combined imaging endpoint of >50% reduction in MAGNIFI-CD score and >20% increase in perianal fistula fibrosis-to-fluid ratio.
1 secondary outcome
Combined Remission
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. IP protection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Executive Vice President, Clinical Affairs, MS contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DB-3Q in people with Perianal Fistula Due to Crohn's Disease, run by Direct Biologics, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Executive Vice President, Clinical Affairs, MS (1-800-791-1021, clinicalaffairs@directbiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Remission (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.