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

Not Applicable

• Conditions: Ulcerative Colitis
• Interventions: Drug: Prednisone; Drug: Azathioprine; Drug: Adalimumab; Biological: umbilical cord blood mononuclear cells

• Registration Number: NCT04882683
• Lead Sponsor: Shandong Qilu Stem Cells Engineering Co., Ltd.

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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Study First Posted: 2021-05-12
• Last Update Posted: 2021-05-12
• Study Start: 2021-06-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UCB-MNCs group	umbilical cord blood mononuclear cells	Prednisone+Azathioprine/Adalimumab+UCB-MNCs
control group	Azathioprine	Prednisone+Azathioprine/Adalimumab
control group	Prednisone	Prednisone+Azathioprine/Adalimumab
UCB-MNCs group	Prednisone	Prednisone+Azathioprine/Adalimumab+UCB-MNCs
control group	Adalimumab	Prednisone+Azathioprine/Adalimumab
UCB-MNCs group	Azathioprine	Prednisone+Azathioprine/Adalimumab+UCB-MNCs
UCB-MNCs group	Adalimumab	Prednisone+Azathioprine/Adalimumab+UCB-MNCs

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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%.
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.
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%.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine; 🇨🇳 Shandong, Shandong, China