RecruitingPhase 1NCT05003947
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IBD
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Inflammatory Bowel Disease
Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
Enrollment
15 participants
Start Date
Jun 11, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of inflammatory bowel disease
Eligibility
Inclusion Criteria2
- Diagnosis of Crohn's disease or Ulcerative Colitis
- Understanding and willingness to sign a written informed consent document
Exclusion Criteria10
- Active infection
- Active cancer
- Chronic multisystem organ failure
- Pregnancy
- Clinically significant Abnormalities on pre-treatment laboratory evaluation
- Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
- Continued drug abuse
- Pre-menopausal women not using contraception
- Previous organ transplant
- Hypersensitivity to sulfur
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Interventions
BIOLOGICALAlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05003947
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