Clinical trial NCT05560672: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Bowel Disease
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of IL-8 in serum
timeFrame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
measure: Concentration of NF-Kβ in serum
timeFrame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
measure: Concentration of IL-6 in serum
timeFrame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
measure: Concentration of IL-1β in serum
timeFrame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
measure: Concentration of Nrf2 in serum
timeFrame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
Secondary outcomes:
Other outcomes:
Locations:
city: JiNan
country: China
facility: HongLi Yang
state: Shandong
Study officials:
References: