RecruitingPhase 2NCT06918808

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

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

Sponsor

Direct Biologics, LLC

Enrollment

36 participants

Start Date

May 19, 2025

Study Type

INTERVENTIONAL

Conditions

Perianal Fistula Due to Crohn's Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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
Single and/or multi-tract perianal fistula(s) with 2 or fewer 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)

Exclusion Criteria9

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
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
Use of investigational therapy or treatment within 30 days prior to Day 1

Interventions

BIOLOGICALDB-3Q

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.

BIOLOGICALPlacebo

0.9% NaCl