Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis

Shandong First Medical University

Status: Active, not recruiting

Conditions: Chronic Atrophic Gastritis

Treatments: Biological: Mononuclear cells; Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules

Study type: Interventional

Funder types: Other

Identifiers

NCT05808010

SWYX:NO.2022-1037

Details and patient eligibility

About

To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects voluntarily participated in the study and signed an informed consent.
2. The age is 18-65 years old, regardless of gender.
3. Patients with chronic atrophic gastritis by gastroscopy and pathological examination.
4. Patients with a negative C13 breath test or have eradicated Helicobacter pylori infection.
5. Patients without contraindications to submucosal injection of umbilical cord blood derived mononuclear cells.

Exclusion criteria

1. Patients with gastric ulcer, erosive gastritis, active upper gastrointestinal bleeding, gastric varices, or other gastric tumors.
2. Patients who are taking or have taken proton pump inhibitors, antibiotics, glucocorticoids, nonsteroidal anti-inflammatory drugs and immunosuppressants in the last six months.
3. People who have had gastric surgery or required gastric surgery during the study.
4. Patients with severe systemic diseases (diseases of cardiovascular, liver, blood, kidneys, lungs or liver).
5. Pregnant or nursing females.
6. Patients who are reluctant to accept endoscopy and treatment.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules

Experimental group

Treatment:

Biological: Mononuclear cells

Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules

Mononuclear cells

Experimental group

Description:

Mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation

Treatment:

Biological: Mononuclear cells

Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules

Active Comparator group

Description:

Weifuchun is a kind of edible Chinese herbal prescription

Treatment:

Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules