Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease

Primary Objectives:

* To evaluate the feasibility of intravenous ExoFlo in subjects with medically refractory 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 medically refractory 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 medically refractory 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 medically refractory 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:

IV administration of 15 mL study agent at Day 0, Day 2, Day 4 and 30 mL at Week 2, Week 6 and every 4 weeks thereafter to week 46 (n=10), (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.