DB-3Q for the Treatment of Medically Refractory Crohn's Disease
ConditionCrohn Disease (CD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDirect Biologics, LLC
About this trial
This research study is studying DB-3Q as a possible treatment for medically refractory Crohn's disease. The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the study drug for Crohn's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent from participant
Males and females 18-75 years of age
Diagnosed with Crohn's disease of at least 6 months duration with medically refractory symptoms that failed to respond or responded but recurred after one advanced immunologic therapy (must have been receiving at least one advanced immunological therapy for 14 weeks duration prior to screening, including, but not limited to, adalimumab, certolizumab, , infliximab, risankizumab, upadacitinib, ustekinumab and vedolizumab), or is intolerant, or has a contraindication to advanced immunological therapy with a next step of subtotal colectomy or escalation in medical management
Active CD as defined by a CDAI score ≥ 220 and/or SES-CD score ≥ 4
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
Clinically significant medical conditions within the six months before initial administration of IMP: e.g., myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the participant
Confirmed Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infections
Trial design
Design model
Sequential
Treatments tested in this trial
DB-3Q
Biological/VaccinebmMSC derived, extracellular vesicle enriched secretome product
Placebo
Other intervention0.9% Saline
Treatment groups
36 Participants
are divided into 4 treatment groupsGroup A: DB-3Q 15 mL IVExperimental treatment 1 intervention
Group B: DB-3Q 30 mL IVExperimental treatment 1 intervention
Group C: DB-3Q 45 mL IVExperimental treatment 1 intervention
Group D: Placebo IVPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in SES-CD Score
Simple Endoscopic Score for Crohn's Disease (SES-CD) is a standardized tool used by gastroenterologists to assess and quantify the severity of Crohn's disease during an endoscopy or colonoscopy. The scale goes from 0 to greater than 15, with a lower score being better.
Time frame
12 WeeksSponsors and contacts
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Source ClinicalTrials.gov