Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline OLGA/OLGIM stages of gastric mucosa
研究概览
简要总结
To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
干预措施: Mononuclear cells (Biological)
Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
干预措施: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules (Drug)
Mononuclear cells
Mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation
干预措施: Mononuclear cells (Biological)
Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Weifuchun is a kind of edible Chinese herbal prescription
干预措施: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules (Drug)
结局指标
主要结局
Change from baseline OLGA/OLGIM stages of gastric mucosa
时间窗: 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
时间窗: 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
次要结局
- 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)
研究者
Xu Hongwei
Chief Physician
Shandong Provincial Hospital