This study conducted a systematic clinical observation of the clinical efficacy of UCB-MNCs in the treatment of hormone-resistant or hormone-dependent ulcerative colitis, in order to observe its clinical safety and efficacy.
This study adopts a randomized and controlled clinical research design. Patients are randomly divided into conventional treatment control group and UCB-MNCs treatment test group. The control group is given conventional treatment: prednisone combined azathioprine or adalimumab; the test group is given conventional treatment combined UCB-MNCs treatment, follow-up observations were carried out, in order to observe the clinical efficacy and safety of UCB-MNCs in the treatment of hormone resistance or hormone-dependent ulcerative colitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
0.75 mg per kilogram per day for three months
1 mg per kilogram per day for three months
40mg every two weeks for three months
The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Shandong, Shandong, China
RECRUITINGClinical efficacy rate
According to the method of modified Mayo score calculation, it is defined as a decrease of ≥30% of the score or a decrease of ≥3 points relative to the baseline value, and a decrease of ≥1 point or a score of 0 or 1 in the sub-item score of blood in the stool, and this type of patient is judged Effective for treatment. Clinical effective rate = (effective number of people / total number of people in this group ) × 100%.
Time frame: Change from Baseline Clinical efficacy rate at 8th and 16th week, and the first week after the end of treatment.
Clinical response rate
According to the method of modified Mayo score calculation, it is defined as a score ≤ 2 points and no single sub-item score\> 1 point. Clinical remission rate =(number of remissions / total number of people in this group) × 100%.
Time frame: Change from Baseline Clinical response rate at 8th and 16th week, and the first week after the end of treatment.
Clinical symptom score
According to the scoring criteria for individual symptoms (diarrhea, mucus pus and blood in the stool, abdominal pain, tenesmus), the severity of symptoms is divided into 0, 2, 4, and 6 points. The higher the score, the more severe the symptoms.
Time frame: Change from Baseline clinical symptom score at the first week after the end of treatment.
Endoscopic response rate
According to the method of modified Mayo score, endoscopy found that the score decreased by at least 1 point from baseline. Endoscopic response rate = (number of endoscopic responders/total number of people in the group) × 100%.
Time frame: Change from Baseline endoscopic response rate at the first week after the end of treatment.
Mucosal healing rate
According to the method of modified Mayo score, the absolute score of the endoscopy discovery score is 0 or 1 point. Mucosal healing rate = (mucosal healing number / total number of people in this group) × 100%.
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Peripheral intravenous infusion method, infusion of umbilical cord blood mononuclear cell suspension 50ml (cell number 2×10\^8).
Time frame: Change from Baseline mucosal healing rate at the first week after the end of treatment.