Chronic Atrophic Gastritis
Conditions
Brief summary
To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.
Interventions
BIOLOGICALMononuclear cells
2 times gastric submucosal injection of mononuclear cells (10\^8) at 1 month interval
DRUGWeifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Orally delivered tablets for 7 months. Take it according to the instructions.
Sponsors
Shandong Provincial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline OLGA/OLGIM stages of gastric mucosa | At the first, seventh and thirteenth month of treatment | Assessment of OLGA/OLGIM stages by GI pathologists. The obtained biopsy specimens will be scored using visual analogue scale (0, 1, 2, 3 points for none, mild, moderate and severe, respectively) to evaluate gastroatrophy and gastrointestinal metaplasia |
| Change from baseline gastric mucosal status under gastroscope | At the first, seventh and thirteenth month of treatment | Assessment of Kimura-Takemoto classification by endoscopy. The variation of atrophy can reflect the extent and degree of atrophy. The severity of atrophy increases gradually with C1-C2-C3-O1-O2-O3. Cases of closed-type gastric mucosa atrophy have an atrophic boundary between the fundic mucosa and the pyloric mucosa in the antrum or less curvature of the gastric body. Cases of open-type gastric mucosa atrophy have an atrophic boundary in the lateral wall or greater curvature of the gastric body. C, closed; O, open |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline blood test result | At the first, seventh and thirteenth month of treatment | Assessment of Gastrin-17 and Pepsinogen I/II |
| Incidence of adverse reactions | Through follow-up period completion, an average of 1 year | Assessment of incidence of adverse reactions |
Countries
China
Outcome results
None listed