Clinical trial
Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
Name
SWYX:NO.2022-1037
Description
To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.
Trial arms
Trial start
2023-06-07
Estimated PCD
2025-04-01
Trial end
2026-04-01
Status
Active (not recruiting)
Treatment
Mononuclear cells
2 times gastric submucosal injection of mononuclear cells (10\^8) at 1 month interval
Arms:
Mononuclear cells, Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Orally delivered tablets for 7 months. Take it according to the instructions.
Arms:
Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules, Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Size
60
Primary endpoint
Change from baseline OLGA/OLGIM stages of gastric mucosa
At the first, seventh and thirteenth month of treatment
Change from baseline gastric mucosal status under gastroscope
At the first, seventh and thirteenth month of treatment
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-04-17
1 organization
2 products
1 indication
Organization
Shandong Provincial HospitalProduct
Mononuclear cellsIndication
Gastritis