To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
2 times gastric submucosal injection of mononuclear cells (10\^8) at 1 month interval
Orally delivered tablets for 7 months. Take it according to the instructions.
Shandong Provincial Hospital
Jinan, Shandong, China
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
Time frame: 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
Time frame: At the first, seventh and thirteenth month of treatment
Change from baseline blood test result
Assessment of Gastrin-17 and Pepsinogen I/II
Time frame: At the first, seventh and thirteenth month of treatment
Incidence of adverse reactions
Assessment of incidence of adverse reactions
Time frame: Through follow-up period completion, an average of 1 year
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