Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IBD
NCT ID: NCT05003947
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2022-06-11
2025-10-31
Brief Summary
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Detailed Description
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For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Single intravenous infusion of 100 million cells
AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Interventions
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AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Eligibility Criteria
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Inclusion Criteria
* Understanding and willingness to sign a written informed consent document
Exclusion Criteria
* 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
ALL
No
Sponsors
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The Foundation for Orthopaedics and Regenerative Medicine
OTHER
Responsible Party
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Principal Investigators
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Chadwick Prodromos, MD
Role: PRINCIPAL_INVESTIGATOR
The Foundation for Orthopaedics and Regenerative Medicine
Locations
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Medical Surgical Associates Center
St John's, , Antigua and Barbuda
Center for Investigation in Tissue Engineering and Cellular Therapy
Buenos Aires, , Argentina
Countries
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Facility Contacts
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References
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Jowett SL, Seal CJ, Barton JR, Welfare MR. The short inflammatory bowel disease questionnaire is reliable and responsive to clinically important change in ulcerative colitis. Am J Gastroenterol. 2001 Oct;96(10):2921-8. doi: 10.1111/j.1572-0241.2001.04682.x.
Wilcox AR, Dragnev MC, Darcey CJ, Siegel CA. A new tool to measure the burden of Crohn's disease and its treatment: do patient and physician perceptions match? Inflamm Bowel Dis. 2010 Apr;16(4):645-50. doi: 10.1002/ibd.21094.
Hu J, Zhao G, Zhang L, Qiao C, Di A, Gao H, Xu H. Safety and therapeutic effect of mesenchymal stem cell infusion on moderate to severe ulcerative colitis. Exp Ther Med. 2016 Nov;12(5):2983-2989. doi: 10.3892/etm.2016.3724. Epub 2016 Sep 20.
Zhang J, Lv S, Liu X, Song B, Shi L. Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial. Gut Liver. 2018 Jan 15;12(1):73-78. doi: 10.5009/gnl17035.
Other Identifiers
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SC-8-ATG-11-04
Identifier Type: -
Identifier Source: org_study_id
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