Clinical Application and Mechanism of Cord Blood Mononuclear Cells in the Treatment of Ischemic Bowel Disease

Ischemic bowel disease, also known as ischemic bowel disease (IBD), is a type of disease that causes the blood supply to a certain intestinal segment to be reduced or stopped by various reasons such as hypovolemia, shock or recent abdominal surgery, resulting in insufficient blood supply to the intestinal wall, and causing a series of pathological changes in the intestine. Human umbilical cord blood mononuclear cells (HUCB-MNC) can be economically and conveniently isolated from human cord blood. The HUCB-MNC obtained from the isolation of human umbilical cord blood contains a variety of stem cells, such as hematopoietic stem cells, endothelial stem cells, etc. A number of previous studies have confirmed that HUCB-MNC can improve the occurrence of ischemic bowel disease through immunomodulatory and tissue repair. These characteristics make HUCB-MNC a cell with great potential to treat ischemic diseases.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Bowel Disease
• Intervention / Treatment: Other: Human Umbilical Cord blood mononuclear cells

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HongLi HL Yang, Dr; Phone Number: 0531-89269883 13791123806; Email: 13791123806@163.com

Study Locations

• China
  • Shandong
    • JiNan, Shandong, China, 250013
      • Recruiting
      • HongLi Yang
      • Contact: HongLi HL Yang, Dr; Phone Number: 13791123806; Email: 13791123806@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age is not limited, gender is not limited. Meet the diagnostic criteria for ischemic bowel disease and clearly diagnose inpatient patients with ischemic bowel disease.
• Diagnosis and diagnosis (standard) in line with the "2011 Chinese Medical.

• Association Gerontology Branch organization of relevant experts jointly wrote the diagnosis and treatment of ischemic bowel disease in the elderly in China":

  1. Acute mesenteric ischemia (AMI): clinical manifestations are acute and severe abdominal pain, symptoms do not match the severity of signs, and signs are often not obvious. Abdominal x-ray may show "finger marks" and balloon signs. CT shows no visualization of the superior mesenteric artery or intraluminal filling defect. Arteriography is helpful in diagnosis, and intestinal mucosal pathology is dominated by ischemic changes, such as in patients with vasculitis, thrombosis, and vascular embolism.
  2. Chronic mesenteric ischemia (CMI): clinical symptoms are recurrent abdominal pain, chronic disease capacity, emaciation, no tenderness in the abdomen, and vascular murmurs can often be heard in the upper abdomen. Imaging tests such as arteriography, CTA, and MRA can help confirm the diagnosis of CMI. It is mainly based on clinical symptoms and advanced imaging tests.
  3. Ischemic colitis (IC): manifested as unexplained abdominal pain, bloody stool, diarrhea or abdominal acute abdomen, which can be diagnosed with colonoscopy and angiography if necessary.

Exclusion Criteria:

• The diagnosis does not conform to the "2011 Cases of Diagnosis and Treatment Recommendations for Ischemic Bowel Disease in the Elderly in China Jointly Written by Relevant Experts organized by the Geriatrics Branch of the Chinese Medical Association";
• Exclude those with serious diseases of other organs;
• Patients with other diseases such as gastrointestinal tumors and inflammatory bowel diseases cannot be excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Cord blood mononuclear cell transplantation is performed at the same time as medical treatments such as fasting, rehydration, hemostasis, anti-infection, vasodilation, repair of intestinal mucosa, regulation of intestinal flora, etc.	Other: Human Umbilical Cord blood mononuclear cells; Intravenous infusion of cord blood mononuclear cells
No Intervention: Control group; Medical treatments such as fasting, rehydration, hemostasis, anti-infection, vasodilation, repair of intestinal mucosa, and regulation of intestinal flora are given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of IL-8 in serum	Ischemic bowel disease increases the expression of IL-8.	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
Concentration of NF-Kβ in serum	In the development of ischemic bowel disease, NFKβ activates the associated signaling pathway to exert an anti-inflammatory effect.	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
Concentration of IL-6 in serum	Ischemic bowel disease increases the expression of IL-6.	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
Concentration of IL-1β in serum	Ischemic bowel disease increases the expression of IL-1β.	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
Concentration of Nrf2 in serum	In the development of ischemic bowel disease, Nrf2 interacts with NF-Kβ and has an anti-inflammatory effect.	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Gastrointestinal Diseases; Ischemia; Intestinal Diseases; Mesenteric Ischemia
• Other Study ID Numbers: YXLL-KY-2020(030)

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