Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Prednisone
* Drug: Azathioprine
* Drug: Adalimumab
* Biological: umbilical cord blood mononuclear cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Western medicine diagnosis is consistent with patients with refractory ulcerative colitis. 2. 18 Years to 65 Years，male or female. 3. Those who voluntarily participate in this clinical study and have signed an informed consent. Exclusion Criteria: 1. Patients with non-refractory UC. 2. Those who are pregnant or breastfeeding, or have a childbirth plan in the near future. 3. People with severe allergies or allergies to known ingredients in basic treatments. 4. Patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, liver and kidney, and hematopoietic system. 5. There are serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon, rectal cancer, etc.. 6. Patients with mental disorders and intellectual disabilities. 7. Patients who have participated in clinical studies of other drugs in the past 3 months. 8. Those who are seriously ill and need emergency treatment. 9. Patients who are still undergoing other treatment options for ulcerative colitis. 10. Researchers believe that it is not suitable for entry.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control group<br>Prednisone+Azathioprine/Adalimumab | Drug: Prednisone<br>* 0.75 mg per kilogram per day for three months<br>* Other names: Meticorten;Drug: Azathioprine<br>* 1 mg per kilogram per day for three months<br>* Other names: Imurel;Drug: Adalimumab<br>* 40mg every two weeks for three months<br>* Other names: Humira;|
| Experimental: UCB-MNCs group<br>Prednisone+Azathioprine/Adalimumab+UCB-MNCs | Drug: Prednisone<br>* 0.75 mg per kilogram per day for three months<br>* Other names: Meticorten;Drug: Azathioprine<br>* 1 mg per kilogram per day for three months<br>* Other names: Imurel;Drug: Adalimumab<br>* 40mg every two weeks for three months<br>* Other names: Humira;Biological: umbilical cord blood mononuclear cells<br>* Peripheral intravenous infusion method, infusion of umbilical cord blood mononuclear cell suspension 50ml (cell number 2×10^8).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical 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%. | 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%. | Change from Baseline Clinical response rate at 8th and 16th week, and the first week after the end of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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%. | 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%. | Change from Baseline mucosal healing rate at the first week after the end of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety and efficacy, Ulcerative colitis, umbilical cord blood mononuclear cells