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To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules | Experimental |
| |
| Mononuclear cells | Experimental | Mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation |
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| Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules | Active Comparator | Weifuchun is a kind of edible Chinese herbal prescription |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mononuclear cells | Biological | 2 times gastric submucosal injection of mononuclear cells (10^8) at 1 month interval |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| hongwei Xu, MD | Shandong Provincial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
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| Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules | Drug | Orally delivered tablets for 7 months. Take it according to the instructions. |
|
| Through follow-up period completion, an average of 1 year |
| ID | Term |
|---|---|
| D005757 | Gastritis, Atrophic |
| ID | Term |
|---|---|
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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