NCT05003947 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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. Epub 2016 Sep 20.
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.
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.
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.

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Inflammatory Bowel Disease

Clinical trial NCT05003947 - References