Direct Biologics, LLC
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: 58 weeks Single or Multi-Site: Multi-Site
Crohn Disease
Inflammatory Bowel Diseases
ExoFlo
Phase 1
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.
Study Type : | Interventional |
Estimated Enrollment : | 10 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | January 23, 2023 |
Estimated Primary Completion Date : | July 1, 2024 |
Estimated Study Completion Date : | September 1, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: 15ml at Day 0, 2, 4, 30 ml at Week 2, Week 6, and every 4 weeks after to week 46 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 (total # doses = 15). |
Biological: ExoFlo |
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Active, not recruiting
Direct Biologics Investigational Site
Los Angeles, California, United States, 90048
Recruiting
Direct Biologics Investigational Site
New York, New York, United States, 10016