A Phase I study on the Safety Allogeneic Human Umbilical Cord Mesenchymal Stem Cells(PF2020-CELL) for Perianal Fistulas in patients with Crohn`s disease
Stem Cell Therapy for Perianal Fistulas in Crohn's Disease
General Information
(1) Primary Measures: Safe and feasible usage without serious adverse events (SAE)
(2) Secondarary Measures: (a) Improvement /closure of openings and Re-epithelialization (b) Improvement in inflammatory markers
In this study, we will be utilizing the conventional 3 + 3 design, as described by Storer in 1989, which is best used in dose-escalation clinical studies. The 3 + 3 dose-escalation method remains the most popular method employed by researchers in phase 1 trials. Based on this design, a total of 7 patients will be recruited which includes a consideration of 20% (one patient) possible patients withdrawal from the trial.
Study Information
Inclusion & Exclusion Criteria
Study Timeline