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

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ClinicalTrials.gov Identifier: NCT04882683
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Prednisone Drug: Azathioprine Drug: Adalimumab Biological: umbilical cord blood mononuclear cells Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: control group
Prednisone+Azathioprine/Adalimumab
Drug: Prednisone
0.75 mg per kilogram per day for three months
Other Names:
  • Deltacortone
  • Meticorten

Drug: Azathioprine
1 mg per kilogram per day for three months
Other Names:
  • Imurek
  • Imurel

Drug: Adalimumab
40mg every two weeks for three months
Other Name: Humira

Experimental: UCB-MNCs group
Prednisone+Azathioprine/Adalimumab+UCB-MNCs
Drug: Prednisone
0.75 mg per kilogram per day for three months
Other Names:
  • Deltacortone
  • Meticorten

Drug: Azathioprine
1 mg per kilogram per day for three months
Other Names:
  • Imurek
  • Imurel

Drug: Adalimumab
40mg every two weeks for three months
Other Name: Humira

Biological: umbilical cord blood mononuclear cells
Peripheral intravenous infusion method, infusion of umbilical cord blood mononuclear cell suspension 50ml (cell number 2×10^8).




Primary Outcome Measures :
  1. 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%.

  2. 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 Outcome Measures :
  1. Clinical symptom score [ Time Frame: 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.

  2. Endoscopic response rate [ Time Frame: 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%.

  3. Mucosal healing rate [ Time Frame: 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%.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04882683


Contacts
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Contact: xueliang C Jiang +8615954103609 jiangxueliang678@126.com

Locations
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China, Shandong
The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine Recruiting
Shandong, Shandong, China
Contact: xueliang Jiang    +86-15954103609    jiangxueliang678@126.com   
Sponsors and Collaborators
Shandong Qilu Stem Cells Engineering Co., Ltd.
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Responsible Party: Shandong Qilu Stem Cells Engineering Co., Ltd.
ClinicalTrials.gov Identifier: NCT04882683    
Other Study ID Numbers: UCB-MNCs-UC-2021
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shandong Qilu Stem Cells Engineering Co., Ltd.:
Ulcerative colitis
umbilical cord blood mononuclear cells
safety and efficacy
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Prednisone
Adalimumab
Azathioprine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antirheumatic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors