Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: control group Prednisone+Azathioprine/Adalimumab |
Drug: Prednisone
0.75 mg per kilogram per day for three months
Other Names:
Drug: Azathioprine
1 mg per kilogram per day for three months
Other Names:
Drug: Adalimumab
40mg every two weeks for three months
Other Names:
|
| Experimental: UCB-MNCs group Prednisone+Azathioprine/Adalimumab+UCB-MNCs |
Drug: Prednisone
0.75 mg per kilogram per day for three months
Other Names:
Drug: Azathioprine
1 mg per kilogram per day for three months
Other Names:
Drug: Adalimumab
40mg every two weeks for three months
Other Names:
Biological: umbilical cord blood mononuclear cells
Peripheral intravenous infusion method, infusion of umbilical cord blood mononuclear cell suspension 50ml (cell number 2×10^8).
|
Outcome Measures
Primary Outcome Measures
- Clinical efficacy rate [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 [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 Outcome Measures
- Clinical symptom score [Change from Baseline clinical symptom score at the first week after the end of treatment.]
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.
- Endoscopic response rate [Change from Baseline endoscopic response rate at the first week after the end of treatment.]
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%.
- Mucosal healing rate [Change from Baseline mucosal healing rate at the first week after the end of treatment.]
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%.
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Western medicine diagnosis is consistent with patients with refractory ulcerative colitis.
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- 18 Years to 65 Years，male or female.
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- Those who voluntarily participate in this clinical study and have signed an informed consent.
Exclusion Criteria:
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- Patients with non-refractory UC.
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- Those who are pregnant or breastfeeding, or have a childbirth plan in the near future.
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- People with severe allergies or allergies to known ingredients in basic treatments.
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- Patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, liver and kidney, and hematopoietic system.
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- There are serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon, rectal cancer, etc..
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- Patients with mental disorders and intellectual disabilities.
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- Patients who have participated in clinical studies of other drugs in the past 3 months.
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- Those who are seriously ill and need emergency treatment.
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- Patients who are still undergoing other treatment options for ulcerative colitis.
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- Researchers believe that it is not suitable for entry.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine | Shandong | Shandong | China |
Sponsors and Collaborators
- Shandong Qilu Stem Cells Engineering Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UCB-MNCs-UC-2021