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

Chronic Atrophic Gastritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05808010
• Other study ID #: SWYX:NO.2022-1037
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: Shandong Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subjects voluntarily participated in the study and signed an informed consent.

2. The age is 18-65 years old, regardless of gender.

3. Patients with chronic atrophic gastritis by gastroscopy and pathological examination.

4. Patients with a negative C13 breath test or have eradicated Helicobacter pylori infection.

5. Patients without contraindications to submucosal injection of umbilical cord blood derived mononuclear cells.

Exclusion Criteria:

1. Patients with gastric ulcer, erosive gastritis, active upper gastrointestinal bleeding, gastric varices, or other gastric tumors.

2. Patients who are taking or have taken proton pump inhibitors, antibiotics, glucocorticoids, nonsteroidal anti-inflammatory drugs and immunosuppressants in the last six months.

3. People who have had gastric surgery or required gastric surgery during the study.

4. Patients with severe systemic diseases (diseases of cardiovascular, liver, blood, kidneys, lungs or liver).

5. Pregnant or nursing females.

6. Patients who are reluctant to accept endoscopy and treatment.

Related Conditions & MeSH terms

• Atrophy
• Chronic Atrophic Gastritis
• Gastritis
• Gastritis, Atrophic

Intervention

Biological:
• Mononuclear cells
2 times gastric submucosal injection of mononuclear cells (10^8) at 1 month interval

Drug:
• Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Orally delivered tablets for 7 months. Take it according to the instructions.

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

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