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

NCT04882683 | Unknown

• 1 other identifier: UCB-MNCs-UC-2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; umbilical cord blood mononuclear cells; safety and efficacy

Outcome Measures

Primary Outcomes (2)

• 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%.

  Change from Baseline Clinical efficacy rate at 8th and 16th week, and the first week after the end of treatment.

• 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%.

  Change from Baseline Clinical response rate at 8th and 16th week, and the first week after the end of treatment.

Secondary Outcomes (3)

• Clinical symptom score

  Change from Baseline clinical symptom score at the first week after the end of treatment.

• Endoscopic response rate

  Change from Baseline endoscopic response rate at the first week after the end of treatment.

• Mucosal healing rate

  Change from Baseline mucosal healing rate at the first week after the end of treatment.

Study Arms (2)

control group

EXPERIMENTAL

Prednisone+Azathioprine/Adalimumab

Drug: Prednisone; Drug: Azathioprine; Drug: Adalimumab

UCB-MNCs group

EXPERIMENTAL

Prednisone+Azathioprine/Adalimumab+UCB-MNCs

Drug: Prednisone; Drug: Azathioprine; Drug: Adalimumab; Biological: umbilical cord blood mononuclear cells

Interventions

Prednisone DRUG

0.75 mg per kilogram per day for three months

Also known as: Deltacortone, Meticorten

UCB-MNCs group; control group

Azathioprine DRUG

1 mg per kilogram per day for three months

Also known as: Imurek, Imurel

UCB-MNCs group; control group

Adalimumab DRUG

40mg every two weeks for three months

Also known as: Humira

UCB-MNCs group; control group

umbilical cord blood mononuclear cells BIOLOGICAL

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

UCB-MNCs group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Western medicine diagnosis is consistent with patients with refractory ulcerative colitis.
• \. 18 Years to 65 Years，male or female.
• \. Those who voluntarily participate in this clinical study and have signed an informed consent.

You may not qualify if:

• \. Patients with non-refractory UC.
• \. Those who are pregnant or breastfeeding, or have a childbirth plan in the near future.
• \. People with severe allergies or allergies to known ingredients in basic treatments.
• \. Patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, liver and kidney, and hematopoietic system.
• \. There are serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon, rectal cancer, etc..
• \. Patients with mental disorders and intellectual disabilities.
• \. Patients who have participated in clinical studies of other drugs in the past 3 months.
• \. Those who are seriously ill and need emergency treatment.
• \. Patients who are still undergoing other treatment options for ulcerative colitis.
• \. Researchers believe that it is not suitable for entry.

Sponsors & Collaborators

• Shandong Qilu Stem Cells Engineering Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Shandong, Shandong, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Prednisone; Azathioprine; Adalimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

xueliang C Jiang

CONTACT

+8615954103609; jiangxueliang678@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 31, 2022
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)