drugset / Trial / NCT05003947
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IBD
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2022-06-11
- Primary completion
- 2025-10
- Completion
- 2025-10
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AlloRx | Cell therapy | 100 cells | Intravenous |