Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease (NCT05130983) | Clinical Trial Compass
TerminatedPhase 1
Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease
Stopped: Enrollment challenges.
United States3 participantsStarted 2023-01-23
Plain-language summary
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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females 18-75 years of age
. Crohn's colitis of at least 6 months duration with medically refractory symptoms who has failed one monoclonal antibody therapy (failed to have improvement of disease while receiving at least one monoclonal antibody for 8 weeks duration prior to enrollment, including, but not limited to, Infliximab, Adalimumab, Certolizumab, Golimumab, Vedolizumab, Ustekinumab and Tofacitinib), or is intolerant, or has a contraindication to monoclonal antibody therapy with a next step of subtotal colectomy or escalation in medical management
. Patient with medically refractory Crohn's disease as defined by a CDAI score ≥150 and/or SES-CD score ≥ 3
. Exposure to corticosteroids, 5-ASA drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 8 weeks for any monoclonal antibody is necessary.
. If receiving conventional immunomodulators (ie, AZA, 6-MP, or MTX), must have been taking them for ≥12 weeks, and on a stable dose for at least 4 weeks prior to receiving the first dose of the study drug.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 58 Weeks
2
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.
. If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks prior to receiving the first dose of study drug.
. If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks. If receiving oral corticosteroids, the dose must be ≤20 mg/day prednisone or its equivalent and must have been stable for at least 4 weeks prior to receiving the first dose of study drug.
. If receiving budesonide, the dose must have been stable for at least 2 weeks prior to receiving the first dose of study drug.
Exclusion criteria
. Inability to give informed consent.
. Clinically significant medical conditions within the six months before administration of ExoFlo: e.g., myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
. Patients with confirmed HIV, Hepatitis B, or Hepatitis C infections
. Abnormal AST or ALT at screening defined as AST \>100 or ALT \> 100
. Abnormal basic laboratory values with the following cut-offs: