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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Human umbilical cord MSCs are transplanted three times by intravenous infusion(1×10\^6/kg) ,once every week，a total of three times.
Normal saline in same volume as MSCs are transplanted to patients.
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, China
RECRUITINGSafety will be determined by the assessment of major adverse events.
Safety will be determined by the assessment of major adverse events defined as fever, allergy or any other intravenous infusion adverse events.
Time frame: Within the six months after intravenous infusion
Clinical response (CDAI points)
CDAI is defined as Clinical Disease Activity Index.
Time frame: Post first cell transplantation: 3 weeks and months 1,3 and 6
Endoscopic improvement is assessed by UCEIS.
UCEIS is defined as Ulcerative Colitis Endoscopic Index of Severity.
Time frame: Post first cell transplantation 6 months
Level of C-reactive protein
Time frame: Post first cell transplantation: 3 weeks and months 1,3 and 6
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