Primary Objectives:~To evaluate the feasibility of intravenous ExoFlo in subjects with moderately to severely active Crohn's disease who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.~To evaluate the safety of intravenous ExoFlo in subjects with moderately to severely active Crohn's disease who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.~Secondary Objectives:~To evaluate the efficacy of intravenous ExoFlo in inducing clinical remission in subjects with moderately to severely active Crohn's disease who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.~To evaluate the efficacy of intravenous ExoFlo in inducing clinical response in subjects with moderately to severely active Crohn's disease who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.~To evaluate the efficacy of intravenous ExoFlo in improving disease-specific health-related quality of life.~To evaluate the pharmacokinetics and pharmacodynamics of ExoFlo therapy, including changes in C-reactive protein (CRP) and fecal calprotectin.~Number of Subjects: 10~Diagnosis and Main Inclusion Criteria: Subjects must have colitis, ileitis, or ileocolitis previously confirmed at any time in the past by radiography, histology, and/or endoscopy, and must allow a ≥ 8-week washout for prior monoclonal antibody therapy.~Study Product, Dose, Route, Regimen:~Arm 1: IV administration of study agent at Day 0, Day 2, Day 4, Week 2, Week 6 and every 8 weeks thereafter to week 46 (n=5), (total # doses = 10).~Arm 2: IV administration of study agent at Day 0, Day 2, Day 4, Week 2, Week 6 and every 4 weeks thereafter to week 46 (n=5), (total # doses = 15).~Statistical Methodology: This is a safety study with exploratory assessment of efficacy. The study has insufficient power to confirm efficacy. All assessments of efficacy will be exploratory for the purpose of hypothesis-generation in larger sample sizes.
Protocol Summary~Title: A Phase I study of ExoFlo, an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product, for the treatment of medically refractory Crohn's disease.~Short Title: ExoFlo for Crohn's Disease~Phase: 1~Methodology: Open label~Study Duration: 24 months~Subject Participation: 70 weeks~Single or Multi-Site: Multi-Site