Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
- Conditions
- Chronic Atrophic Gastritis
- Interventions
- Biological: Mononuclear cellsDrug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
- Registration Number
- NCT05808010
- Lead Sponsor
- Shandong Provincial Hospital
- Brief Summary
To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules Mononuclear cells - Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules - Mononuclear cells Mononuclear cells Mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules Weifuchun is a kind of edible Chinese herbal prescription
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China