Back to results

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

Primary Purpose

Ischemic Bowel Disease

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Human Umbilical Cord blood mononuclear cells

About this trial

This is an interventional treatment trial for Ischemic Bowel Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

HongLi YangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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.

Medical treatments such as fasting, rehydration, hemostasis, anti-infection, vasodilation, repair of intestinal mucosa, and regulation of intestinal flora are given.

Outcomes

Primary Outcome Measures

Concentration of IL-8 in serum

Ischemic bowel disease increases the expression of IL-8.

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.

Concentration of IL-6 in serum

Ischemic bowel disease increases the expression of IL-6.

Concentration of IL-1β in serum

Ischemic bowel disease increases the expression of IL-1β.

Concentration of Nrf2 in serum

In the development of ischemic bowel disease, Nrf2 interacts with NF-Kβ and has an anti-inflammatory effect.

Secondary Outcome Measures

Full Information

NCT ID

NCT05560672

First Posted

September 20, 2022

Last Updated

September 26, 2022

Sponsor

Qianfoshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05560672

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qianfoshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Bowel Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Medical treatments such as fasting, rehydration, hemostasis, anti-infection, vasodilation, repair of intestinal mucosa, and regulation of intestinal flora are given.

Intervention Type

Other

Intervention Name(s)

Human Umbilical Cord blood mononuclear cells

Intervention Description

Intravenous infusion of cord blood mononuclear cells

Primary Outcome Measure Information:

Title

Concentration of IL-8 in serum

Description

Ischemic bowel disease increases the expression of IL-8.

Time Frame