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

May 11, 2021 updated by: Shandong Qilu Stem Cells Engineering Co., Ltd.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Shandong, Shandong, China
        • Recruiting
        • The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: control group
Prednisone+Azathioprine/Adalimumab
Drug: Prednisone
0.75 mg per kilogram per day for three months
Other Names:
  • Meticorten
  • Deltacortone
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 Names:
  • Humira
Experimental: UCB-MNCs group
Prednisone+Azathioprine/Adalimumab+UCB-MNCs
Drug: Prednisone
0.75 mg per kilogram per day for three months
Other Names:
  • Meticorten
  • Deltacortone
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 Names:
  • 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
Change from Baseline Clinical efficacy rate at 8th and 16th week, and the first week after the end of treatment.
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%.
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
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.
Change from Baseline clinical symptom score at the first week after the end of treatment.
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%.
Change from Baseline endoscopic response rate at the first week after the end of treatment.
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%.
Change from Baseline mucosal healing rate at the first week after the end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Qilu Stem Cells Engineering Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCB-MNCs-UC-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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