Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.

Official Title
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Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis

Conditions
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Chronic Atrophic Gastritis

Intervention / Treatment
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* Biological: Mononuclear cells
* Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules<br> | Biological: Mononuclear cells<br>* 2 times gastric submucosal injection of mononuclear cells (10^8) at 1 month interval<br>Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules<br>* Orally delivered tablets for 7 months. Take it according to the instructions.<br>|
| Experimental: Mononuclear cells<br>Mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation | Biological: Mononuclear cells<br>* 2 times gastric submucosal injection of mononuclear cells (10^8) at 1 month interval<br>|
| Active Comparator: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules<br>Weifuchun is a kind of edible Chinese herbal prescription | Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules<br>* Orally delivered tablets for 7 months. Take it according to the instructions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline OLGA/OLGIM stages of gastric mucosa | 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 | At the first, seventh and thirteenth month of treatment | 
| Change from baseline gastric mucosal status under gastroscope | 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 | At the first, seventh and thirteenth month of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline blood test result | Assessment of Gastrin-17 and Pepsinogen I/II | At the first, seventh and thirteenth month of treatment | 
| Incidence of adverse reactions | Assessment of incidence of adverse reactions | Through follow-up period completion, an average of 1 year |