Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
Overview
- Phase
- Not Applicable
- Intervention
- Prednisone
- Conditions
- Ulcerative Colitis
- Sponsor
- Shandong Qilu Stem Cells Engineering Co., Ltd.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Clinical efficacy rate
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Western medicine diagnosis is consistent with patients with refractory ulcerative colitis.
- •18 Years to 65 Years，male or female.
- •Those who voluntarily participate in this clinical study and have signed an informed consent.
Exclusion Criteria
- •Patients with non-refractory UC.
- •Those who are pregnant or breastfeeding, or have a childbirth plan in the near future.
- •People with severe allergies or allergies to known ingredients in basic treatments.
- •Patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, liver and kidney, and hematopoietic system.
- •There are serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon, rectal cancer, etc..
- •Patients with mental disorders and intellectual disabilities.
- •Patients who have participated in clinical studies of other drugs in the past 3 months.
- •Those who are seriously ill and need emergency treatment.
- •Patients who are still undergoing other treatment options for ulcerative colitis.
- •Researchers believe that it is not suitable for entry.
Arms & Interventions
control group
Prednisone+Azathioprine/Adalimumab
Intervention: Prednisone
control group
Prednisone+Azathioprine/Adalimumab
Intervention: Azathioprine
control group
Prednisone+Azathioprine/Adalimumab
Intervention: Adalimumab
UCB-MNCs group
Prednisone+Azathioprine/Adalimumab+UCB-MNCs
Intervention: Prednisone
UCB-MNCs group
Prednisone+Azathioprine/Adalimumab+UCB-MNCs
Intervention: Azathioprine
UCB-MNCs group
Prednisone+Azathioprine/Adalimumab+UCB-MNCs
Intervention: Adalimumab
UCB-MNCs group
Prednisone+Azathioprine/Adalimumab+UCB-MNCs
Intervention: umbilical cord blood mononuclear cells
Outcomes
Primary Outcomes
Clinical efficacy rate
Time Frame: Change from Baseline Clinical efficacy rate at 8th and 16th week, and the first week after the end of treatment.
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%.
Clinical response rate
Time Frame: Change from Baseline Clinical response rate at 8th and 16th week, and the first week after the end of treatment.
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%.
Secondary Outcomes
- Endoscopic response rate(Change from Baseline endoscopic response rate at the first week after the end of treatment.)
- Clinical symptom score(Change from Baseline clinical symptom score at the first week after the end of treatment.)
- Mucosal healing rate(Change from Baseline mucosal healing rate at the first week after the end of treatment.)