Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
Overview
- Phase
- Not Applicable
- Intervention
- Mononuclear cells
- Conditions
- Chronic Atrophic Gastritis
- Sponsor
- Shandong Provincial Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change from baseline OLGA/OLGIM stages of gastric mucosa
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.
Investigators
Xu Hongwei
Chief Physician
Shandong Provincial Hospital
Eligibility Criteria
Inclusion Criteria
- •Subjects voluntarily participated in the study and signed an informed consent.
- •The age is 18-65 years old, regardless of gender.
- •Patients with chronic atrophic gastritis by gastroscopy and pathological examination.
- •Patients with a negative C13 breath test or have eradicated Helicobacter pylori infection.
- •Patients without contraindications to submucosal injection of umbilical cord blood derived mononuclear cells.
Exclusion Criteria
- •Patients with gastric ulcer, erosive gastritis, active upper gastrointestinal bleeding, gastric varices, or other gastric tumors.
- •Patients who are taking or have taken proton pump inhibitors, antibiotics, glucocorticoids, nonsteroidal anti-inflammatory drugs and immunosuppressants in the last six months.
- •People who have had gastric surgery or required gastric surgery during the study.
- •Patients with severe systemic diseases (diseases of cardiovascular, liver, blood, kidneys, lungs or liver).
- •Pregnant or nursing females.
- •Patients who are reluctant to accept endoscopy and treatment.
Arms & Interventions
Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Intervention: Mononuclear cells
Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Intervention: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Mononuclear cells
Mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation
Intervention: Mononuclear cells
Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Weifuchun is a kind of edible Chinese herbal prescription
Intervention: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Outcomes
Primary Outcomes
Change from baseline OLGA/OLGIM stages of gastric mucosa
Time Frame: 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
Time Frame: 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 Outcomes
- Change from baseline blood test result(At the first, seventh and thirteenth month of treatment)
- Incidence of adverse reactions(Through follow-up period completion, an average of 1 year)