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

NCT05808010 NA UNKNOWN

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

Details

Lead sponsor	Shandong Provincial Hospital
Phase	NA
Status	UNKNOWN
Enrolment	60
Start date	2023-06-07
Completion	2026-04

Conditions

• Chronic Atrophic Gastritis

Interventions

• Mononuclear cells
• Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules

Primary outcomes

• 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

Countries

China