Back to resultsClinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prednisone
Azathioprine
Adalimumab
umbilical cord blood mononuclear cells
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis, umbilical cord blood mononuclear cells, safety and efficacy
Eligibility Criteria
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.
Sites / Locations
- The Second Affiliated Hospital of Shandong University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
control group
UCB-MNCs group
Arm Description
Prednisone+Azathioprine/Adalimumab
Prednisone+Azathioprine/Adalimumab+UCB-MNCs
Outcomes
Primary Outcome Measures
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%.
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%.
Secondary Outcome Measures
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.
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%.
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%.
Full Information
NCT ID
NCT04882683
First Posted
May 6, 2021
Last Updated
May 11, 2021
Sponsor
Shandong Qilu Stem Cells Engineering Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04882683
Brief Title
Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
Official Title
Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Qilu Stem Cells Engineering Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis, umbilical cord blood mononuclear cells, safety and efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Experimental
Arm Description
Prednisone+Azathioprine/Adalimumab
Arm Title
UCB-MNCs group
Arm Type
Experimental
Arm Description
Prednisone+Azathioprine/Adalimumab+UCB-MNCs
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Deltacortone, Meticorten
Intervention Description
0.75 mg per kilogram per day for three months
Intervention Type
Drug
Intervention Name(s)
Azathioprine
Other Intervention Name(s)
Imurek, Imurel
Intervention Description
1 mg per kilogram per day for three months
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
40mg every two weeks for three months
Intervention Type
Biological
Intervention Name(s)
umbilical cord blood mononuclear cells
Intervention Description
Peripheral intravenous infusion method, infusion of umbilical cord blood mononuclear cell suspension 50ml (cell number 2×10^8).
Primary Outcome Measure Information:
Title
Clinical efficacy rate
Description
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.
Title
Clinical response rate
Description
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.
Secondary Outcome Measure Information:
Title
Clinical symptom score
Description
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.
Title
Endoscopic response rate
Description
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.
Title
Mucosal healing rate
Description
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%.
Time Frame
Change from Baseline mucosal healing rate at the first week after the end of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xueliang C Jiang
Phone
+8615954103609
Email
jiangxueliang678@126.com
Facility Information:
Facility Name
The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Shandong
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xueliang Jiang
Phone
+86-15954103609
Email
jiangxueliang678@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
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