DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDirect Biologics, LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
DB-3Q
Biological/VaccineDB-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.
Placebo
Biological/Vaccine0.9% NaCl
Treatment groups
36 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Single dose DB-3Q 15 mL direct injectionExperimental treatment 1 intervention
Group B: Single dose Placebo 15 mL direct injectionPlacebo comparator 1 intervention
Group C: Single dose DB-3Q 30 mL direct injectionExperimental treatment 1 intervention
Group D: Single dose Placebo 30 mL direct injectionPlacebo comparator 1 intervention
Group E: Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injectionExperimental treatment 1 intervention
Group F: Single dose Placebo 15 ml IV and Placebo 30 mL direct injectionPlacebo comparator 1 intervention
Trial outcomes
Primary 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.
Time frame
24 WeeksSecondary 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.
Time frame
12 WeeksSponsors and contacts
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Source ClinicalTrials.gov