Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 75 Years|
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This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Direct Biologics, LLC|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Vikram Sengupta, MD|
|Principal Investigator Affiliation||Direct Biologics|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Crohn Disease, IBD - Irritable Bowel Disease|
Experimental: 15ml of ExoFlo at Day 0, 2, 4 Week 2, 6, and every 8 weeks after that to week 46
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).
Experimental: 15ml of ExoFlo at Day 0, 2, 4 Week 2, 6, and every 4 weeks after that to week 46
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).
Drug: - Bone Marrow MSC Derived Extracellular Vesicle Isolate
ExoFlo 15ml, IV