Ulcerative Colitis Clinical Trial
Official title:
Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem
cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind,
controlled prospective study.
Thirty patients will be selected and randomized into two groups: the first group of 15
patients will receive a sole injection of UC-MSC and the remaining 15 patients will comprise
the control group.
Every patient will maintain their standard treatment of active ulcerative colitis, with
maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided
into 0-1 week, 1 week-2 week,2 week-3 week, 3 week-1 month, and 3 month-6 months.
Clinical results will be analyzed after completion of 6 months of followup.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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