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

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)