Ischemic Bowel DiseaseNCT05560672
Clinical Application and Mechanism of Cord Blood Mononuclear Cells in the Treatment of Ischemic Bowel Disease
A study testing Human Umbilical Cord blood mononuclear cells in people with Ischemic Bowel Disease, run by Qianfoshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Bowel Disease
- What is being tested?
- Human Umbilical Cord blood mononuclear cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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":
- 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.
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
HongLi Yang
Jinan, Shandong, 250013
HongLi HL Yang, Dr, 13791123806, 13791123806@163.com
About this study
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.
- Conditions
- Ischemic Bowel Disease
- Being tested
- Human Umbilical Cord blood mononuclear cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Umbilical Cord blood mononuclear cellsOther
Intravenous infusion of cord blood mononuclear cells
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Other: Human Umbilical Cord blood mononuclear cells |
| Control group | No intervention | Medical treatments such as fasting, rehydration, hemostasis, anti-infection, vasodilation, repair of intestinal mucosa, and regulation of intestinal flora are given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of IL-8 in serum
Ischemic bowel disease increases the expression of IL-8.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Sep 2019
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560672
- Sponsor's protocol ID
- YXLL-KY-2020(030)
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application and Mechanism of Cord Blood Mononuclear Cells in the Treatment of Ischemic Bowel Disease
- ClinicalTrials.gov ID
- NCT05560672
- Acronym / sponsor ID
- YXLL-KY-2020(030)
- Conditions
- Ischemic Bowel Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Human Umbilical Cord blood mononuclear cellsCord 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. |
| Control group | No intervention | –Medical treatments such as fasting, rehydration, hemostasis, anti-infection, vasodilation, repair of intestinal mucosa, and regulation of intestinal flora are given. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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":
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Umbilical Cord blood mononuclear cellsIntravenous infusion of cord blood mononuclear cells | Other | Experimental group |
Primary outcome
Concentration of IL-8 in serum
Time frame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
Ischemic bowel disease increases the expression of IL-8.
Concentration of NF-Kβ in serum
Time frame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
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
Time frame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
Ischemic bowel disease increases the expression of IL-6.
Concentration of IL-1β in serum
Time frame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
Ischemic bowel disease increases the expression of IL-1β.
Concentration of Nrf2 in serum
Time frame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after
In the development of ischemic bowel disease, Nrf2 interacts with NF-Kβ and has an anti-inflammatory effect.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Umbilical Cord blood mononuclear cells in people with Ischemic Bowel Disease, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HongLi HL Yang, Dr (13791123806 ext. 0531-89269883, 13791123806@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of IL-8 in serum (time frame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.